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  • With the exception of Getting into Medical Writing, this is a members only event 

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Registration includes all conference materials and attendance at events, subject to registration for the relevant days.
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Full (Tuesday to Friday)

Get the complete EMWA Spring Conference experience with access from Tuesday to Friday giving you the most value and flexibility.

Registration includes all conference materials and attendance at the following events, subject to registration for the relevant days: Opening Sessions followed by the networking event and welcome reception; Freelance Business Forum; Getting into Medical Writing, round tables, lunchtime seminars; and lunches and coffee breaks.

There is no additional charge for the Symposium, provided you purchase full registration, 1 or 2 day registration that includes the Symposium Day.

The registration fee does not include attending EMWA Professional Development Programme (EPDP) workshops or Expert Seminar Series (ESS) sessions. These are charged separately. 

Accompanying Person Options

Opening Session, Evening drinks & buffet, lunch and coffee breaks only.
The networking buffet and drinks can be purchased by changing the quantity in your basket.

Virtual Attendance

Virtual attendance: Full Conference (incl. Opening Session, Symposium and all ESS’s)

Virtual Attendance: Getting into Medical Writing

Virtual attendance: Symposium

Virtual attendance: ESS1

Virtual attendance: ESS2

Virtual attendance: ESS3

Virtual attendance: ESS4

EC Members, Workshop Leaders and Speakers, please check your email for your coupon code.

Below you will find programme details for the 59th EMWA conference in Riga.

Please note this programme is subject to change. All timings are in EET (Eastern European Time)

Tuesday, 6th May, 2025

9:00 am to 4:00 pm

In addition to giving a presentation covering all aspects of medical writing, the seminar leader will act as a facilitator to optimise exchange of experience between participants, as well as providing insight based on her expertise in this area.

The aim is to provide information on the following:

  • Definition of medical writing and its different categories
  • Role of the medical writer throughout the life-cycle of a pharmaceutical product
  • Explanation of the different types of documents that we write, with more detailed information on some of the most common (e.g. clinical study protocols and reports, investigator brochures, CTDs, manuscripts, posters)
  • Finding a job as a medical writer (qualities and qualifications required), types of companies that employ medical writers, recruitment process, working as a freelancer
  • Training and networking for medical writers

Members of the public who wish to attend the seminar should approach the EMWA Staff at the Conference registration desk who will issue them with a temporary badge and direct them to the seminar room.

Participant profile: This seminar is aimed at those considering a career in medical writing. It is open to conference delegates and members of the general public. It will also be interesting to those who have recently joined the profession who would like to know more.

Welcome

Welcome

Evguenia Alechine

Evguenia finished her PhD in biochemistry at the University of Buenos Aires before finding her true passion in science communication. At EMWA, she is the co-editor of the Medical Writing journal and chair of the GIMW Programme Committee. She is a passionate educator with 15+ years of teaching experience. She is currently a freelance science communication lecturer, a career coach, and a founding partner at Alquimia CMC.

Introduction to medical writing

Introduction to medical writing

Sarah Hopwood

Sarah is Vice President of Global Medical Writing at Veristat, where she provides strategic oversight of medical writing activities supporting global drug development programs.

A neuroscientist by training, Sarah began her career as a medical writer in 2006 and has over two decades of experience across consultancy, CRO, and medical communications settings. Her work has focused on regulatory and clinical documentation supporting development from early clinical phases through regulatory submissions and post-marketing activities.

Before joining Veristat in 2023, Sarah held senior leadership roles at Scinopsis, including Director of Medical Writing and Chief Operating Officer. Earlier in her career, she worked in medical communications agencies supporting global pharmaceutical clients.

Sarah serves as Membership Officer on EMWA’s Executive Committee and is co-chair of EMWA’s Getting into Medical Writing initiative. She is passionate about encouraging and supporting professionals entering the field.

She holds a PhD in Neuropharmacology from the University of London and is based in the South of France.

Med Comms

Med Comms

Helen Chambers
Helen is the Medical Communications Director at Costello Medical Consulting, overseeing the company’s Publications, Medical Affairs and Creative service offerings across the UK, North America and Asia. Her focus is on ensuring that the team and the work they deliver is at the forefront of the latest industry developments, such as the development of digital content, patient engagement and AI.
Helen holds the Certified Medical Publication Professional™ (CMPP™) credential from the International Society for Medical Publications Professionals (ISMPP), an Advanced Certificate in Medical Writing from EMWA, and serves as a member of the EMWA Professional Development Committee and the ISMPP Publications Ethics & Standards Committee. She also delivers guest lectures on the University of Cambridge Therapeutic Sciences MPhil course on Medical Communication.
Regulatory medical writing

Regulatory medical writing

Sarah Hopwood

Sarah is Vice President of Global Medical Writing at Veristat, where she provides strategic oversight of medical writing activities supporting global drug development programs.

A neuroscientist by training, Sarah began her career as a medical writer in 2006 and has over two decades of experience across consultancy, CRO, and medical communications settings. Her work has focused on regulatory and clinical documentation supporting development from early clinical phases through regulatory submissions and post-marketing activities.

Before joining Veristat in 2023, Sarah held senior leadership roles at Scinopsis, including Director of Medical Writing and Chief Operating Officer. Earlier in her career, she worked in medical communications agencies supporting global pharmaceutical clients.

Sarah serves as Membership Officer on EMWA’s Executive Committee and is co-chair of EMWA’s Getting into Medical Writing initiative. She is passionate about encouraging and supporting professionals entering the field.

She holds a PhD in Neuropharmacology from the University of London and is based in the South of France.

Applying your transferable skills to regulatory writing

Applying your transferable skills to regulatory writing

Matthew Edmonds
CVs, LinkedIn & online networking

CVs, LinkedIn & online networking

Evguenia Alechine

Evguenia finished her PhD in biochemistry at the University of Buenos Aires before finding her true passion in science communication. At EMWA, she is the co-editor of the Medical Writing journal and chair of the GIMW Programme Committee. She is a passionate educator with 15+ years of teaching experience. She is currently a freelance science communication lecturer, a career coach, and a founding partner at Alquimia CMC.

The EMWA universe (conference offerings, LEGs, Hubs, ambassadors, journal, EPDC)

The EMWA universe (conference offerings, LEGs, Hubs, ambassadors, journal, EPDC)

Abe Shevack

Abe F. Shevack MA, ELS is a Biologist with many years of experience in basic research in both academia and industry. He is also a certified Editor in the Life Sciences. For over 20 years as a senior scientific medical writer at Schering and Bayer, Abe wrote numerous regulatory documents including clinical study protocols, investigator’s brochures, study reports, and common technical documents (CTD) for global regulatory submissions. He has worked in a wide range of therapeutic indications and has participated in successful global marketing authorisations for new drugs in leukaemia, non-Hodgkin’s lymphoma, hepatic cell carcinoma, macular degeneration, and men’s health. Since 2016, Abe has been the owner of Associated Medical Writer Services where he writes and consults for clients in pharma and biotech. He has been a member of EMWA since 1996 and is a past-President (2017-2018) and workshop leader. He is currently the chair of the EMWA Ambassador’s Programme.

Freelancing

Freelancing

Heather L. Mason

Heather worked in both clinical operations and medical affairs departments for eight years before turning to medical writing in 2010. She has been a freelance writer since 2018, working in a wide range of therapeutic areas for pharma, biotech, not-for-profit, and patient organisations. Her specialist area of interest is rare diseases, and she writes predominantly in medical communications, ranging from conference coverage and manuscripts to patient-focused materials and whole project management. Since working on rare diseases and having a son with a disability, she has a passion for patient advocacy, understanding first-hand how non-inclusivity can adversely affect the day-to-day lives of people.

AI in medical writing

AI in medical writing

Namrata Singh

MBA is a physician turned medical writer with a passion to communicate science and medicine to different audiences: Right content for the right audience and at the right platform. She is the founder of Turacoz Group which provides strategic solutions to biopharma companies, medical technology firms, healthcare professionals, and research institutes around medical writing, evidence generation, insights gathering and medical education.

She has been involved in mentoring and training medical writers including the recent technology advancements. She is an active member of societies like European Medical Writers Association (EMWA), American Medical Writers Association (AMWA) and International Society of Medical Publication Professionals (ISMPP). She is the chair of AI working group and Entrepreneurship Special Interest Group at EMWA. She participates as speaker, organizing member and has authored publications around medical writing. She is based in Utrecht, The Netherlands.

Meeting those who make EMWA (EC members and group chairs)

Meeting those who make EMWA (EC members and group chairs)

Evguenia Alechine

Evguenia finished her PhD in biochemistry at the University of Buenos Aires before finding her true passion in science communication. At EMWA, she is the co-editor of the Medical Writing journal and chair of the GIMW Programme Committee. She is a passionate educator with 15+ years of teaching experience. She is currently a freelance science communication lecturer, a career coach, and a founding partner at Alquimia CMC.

4:00 pm - 9:00 pm

Registration opens

Registration opens at 4pm on 5th May and will remain open throughout the conference.

Please visit the registration desk to collect your badge.

5:30 pm – 7:00 pm

Geoff Hall update

Lisa Chamberlain James

Lisa is a Senior Partner of Trilogy Writing & Consulting. Aside from management activities, she leads client projects, with extensive experience in a variety of documents. Lisa has a special interest in writing for the public, and in the effective and ethical use of AI in medical writing. Following a PhD and post doc. in Pathology at Cambridge, Lisa began her medical writing career in 2000. Since then, she has been involved in the European Medical Writers Association (EMWA) as a member of the Educational Committee, mentor, leader, and assessor of workshops, and is a member of the American Medical Writers Association (AMWA)’s Executive Forum, AI Task Force, and teaches and reviews workshops for AMWA. Lisa regularly takes part in podcasts, articles, and is a member of several global, pan-industry panels and committees. She holds an EMWA professional development certificate, is a visiting lecturer for King’s College London and the University of Lisbon, initiated and chaired EMWA’s first Special Interest Group (in PV) and is the current chair of the Communicating with the Public SIG, and the Geoff Hall Scholarship Committee. She is section editor of the ‘Medical Communications and Writing for the Public’ section of Medical Writing, is an EMWA Nick Thompson Fellow, and a Fellow of the Royal Society of Medicine.

Regulatory Chaos to Clarity: AI-Powered Compliance for MedTech

This session shares practical tools to help medical writers handle EU MDR documentation challenges. It will demonstrate how understanding device classification simplifies documentation planning and explain efficient methods for tracking and applying regulatory updates. Using real examples from Class I through Class III devices, attendees will explore approaches that save research time and prevent documentation gaps in technical files and clinical evaluation reports.

The session includes case studies showing how writers can organize requirements for different device types and maintain compliance as regulations evolve. Attendees will learn practical strategies to streamline documentation without compromising quality or compliance.

Arta Zikmane

Is a medical engineering and physics graduate with 15 years of experience in the medical technology sector. Her career has progressed from regional sales to managing distributor partnerships across Eastern and Central Europe for a genetic sequencing corporation. This experience has provided valuable insight into the challenges of implementing medical technology across diverse healthcare systems.
Arta holds an MBA in Innovation Leadership and she is currently developing a healthcare technology venture. Her ongoing professional development includes exploring artificial intelligence applications in healthcare while enhancing technical skills in AI.

Arta’s background combines technical expertise with commercial experience, enabling her to effectively translate complex medical innovations into practical market solutions.

Welcome to Latvia

I’m excited to take you on a journey through Latvia, a beautiful country of four regions with our own traditions. Latvia is a country that experiences all four seasons, each bringing its own unique charm. From snowy winters to vibrant springs, sunny summers, and colourful autumns, Latvia offers a diverse and picturesque environment throughout the year. I will introduce you to several traditional dishes, as well as provide the information where you can find them. Finally, I will tell you about the most interesting places in Riga that you can visit.

Olita Stanislavska

Medical doctor`s degree and master of social sciences. Professional experience of regulatory affairs, preparation and writing of regulatory documentation, safety and quality assurance, non-clinical and clinical studies, SOPs, and promotional and educational materials for medicines, medical devices, and cosmetics.

Wednesday, 7th May, 2025

7:45 am - 8:30 am

English breakfast’ Round table session

In this session, we’ll explore the realms of hyphens, articles, and serial commas. Whether English is your first language or you’re navigating it as a foreign language, come share your thoughts, ask questions, and gain insights into the nuances of English grammar. Feel free to grab some breakfast and bring it with you!

Johanna Svanberg

Johanna Svanberg studied physical chemistry in the UK. After finishing her DPhil, she worked as a freelance science writer and editor before turning to regulatory medical writing in 2022. Johanna currently works for Optimapharm.

7:45 am - 8:30 am

Round Table Session: Sustainability in healthcare – an update and open discussion

During this round table, we will provide updates on policies and initiatives to make the healthcare industry more sustainable. As medical writers, embedded in healthcare – from protocol to publication to patient brochure – we can be part of this change. We invite EMWA members to come join the discussion, ask questions, and share ideas and/or their own sustainability experiences. 

Kimi Uegaki

Kimi Uegaki, PhD is a freelance medical writer/editor and sustainability enthusiast. She has written about preventing research waste and has worked on projects involving FAIR data sharing, natural substance-based medical devices, and drug repurposing. She currently serves as the Chair of EMWA’s SUS-SIG.

Catarina Leitao

Catarina Leitão, PhD has been a medical writer since 2017. She also volunteers at the non-governmental organisations Ocean Alive and Circular Economy Portugal. Her volunteer work has included participating in plastic clean-up campaigns, repair cafés, and creating an urban agroforest. She is currently the Chair of the General Assembly Board of Circular Economy Portugal and an EMWA SUS-SIG core committee member.

8:45 am to 12:30 pm

Organisers: Sarah Milner & Jules Kovacevic  Regulatory-SIG

There are significant differences in approach, when communicating with children and their caregivers compared to adults. Differences in terms of priorities, understanding, accessibility, and appropriateness must all be considered when communicating with this population.

This session will have speakers including; patient advocates, a parent, a regulatory writer, a regulatory professional, and a healthcare professional. There will be presentations describing the stakeholders’ contribution to document design; and how “informed” the consent and assent processes are in practice. In addition, we will look at how regulatory requirements are communicated in the child’s voice to ensure understanding; and which new techniques the professionals are employing to ensure this unique cohort is both heard and involved.

Our speakers bring diversity in their personal and professional perspectives in communicating with children and their caregivers.

Paediatric patient facing documents: involving children and young people

Paediatric patient facing documents: involving children and young people

The involvement of children and young people in the drug development process is not common practice. Regulatory agencies, such as the European Medicines Agency (EMA), encourage patient involvement in study protocol design, and there is evidence of the benefits of incorporating patients’ voices into this process. Despite this, the expertise required to involve minors in health science projects remains a limitation to ensuring that this practice becomes standard.

The European Young Person’s Advisory Group Network (eYPAGnet), accredited by EnprEMA (European Networks of Paediatric Research at EMA), was set up in 2017 by four paediatric hospitals with the aim of providing a solid infrastructure to support the involvement of paediatric patients and parents in drug development. This is achieved through the design of bespoke patient involvement plans and the delivery of these services by well-known experts across Europe.

Patient-facing documents, such as patient information sheets, assent forms, educational materials, and lay summaries, are areas where patients and parents can provide a unique perspective. Their input helps ensure that these materials are appropriate for their health literacy levels, needs, and expectations, ultimately empowering them to be active participants in clinical research projects.

The aim of this presentation is to introduce the services, methods, and lessons learned from more than 10 years of activities carried out with the active participation of young patients and parents as experts providing advice in health research projects.

Begoña Nafría, Head of patient engagement in research at SJD Children’s Hospital, Spain

Begonya Nafria is Head of Department at Sant Joan de Déu Chidren’s Hospital (Spain). She has long experience in the field of patient and family involvement in research initiatives. She has also a personal story as a caregiver and patient advocate because she is the sister of an adult with cerebral palsy.

Her areas of expertise are paediatric patient involvement in research, and specifically in the field of clinical trials. She is currently a PhD student focusing on children’s rights with respect to their participation in clinical studies.

Other relevant background of Begonya’s profile includes: Fellow of EUPATI (first cohort), Coordinator of eYPAGnet (European Young Patients Advisory Group Network – www.eypagnet.eu), Coordinator of Kids Barcelona (www.kidsbarcelona.org), member of Children’s Medicines Working Party of EFPGCP, chair of the working the working group of cross-border access to clinical trials at EmprEMA, and member of the EUPATI Board.

Coordinator of the cross-cutting theme of patients’ involvement in Conect4Children project (pan-European paediatric clinical trials network).

Mastering the ICF and Assent Best Practises

Mastering the ICF and Assent Best Practises

Effective communication with children and parents involved in clinical trials is crucial for fostering trust and ensuring informed participation. Ensuring that children and their parents fully understand the information provided during clinical trial participation is both a legal and ethical imperative.

However, the complexity and length of informed consent forms (ICFs) often pose significant challenges. This presentation will explore the key issues surrounding the design and delivery of trial information to families, including language accessibility, readability, and the emotional and cognitive needs of children and their guardians. It will also highlight common barriers in ICFs, such as medical jargon, lack of age-appropriate content, and insufficient emphasis on participants’ rights and potential risks. By examining best practices and innovative approaches to simplify and personalise trial information, this session aims to improve understanding, empower decision-making, and enhance the overall experience for families in clinical trials.

Bojana Mirosavljevic, ZIVOT (LIFE) Patient Organisation, Serbia & Balkan Region

Bojana Mirosavljevic is the Director of Patient Advocacy Strategy at ICON, and has 15+ years of Rare Disease Patient Advocacy Strategy experience focused on the clinical development process. Bojana has extensive experience in creating and implementing Patient Advocacy strategies for rare diseases in pharma and contract research organisations (CROs). Bojana is a chemist and embryologist specialised in pre-implantation genetic testing (PGT). 

Bojana is the Founder and President of ZIVOT (LIFE), a Patient Organisation operating in Serbia and the Balkan region. She successfully lobbied for Zoya’s law, which increased access to early diagnostic and newborn screening in Serbia.  She is a certified EUPATI Patient Expert for Rare Diseases and was a recipient of the prestigious EURORDIS Black Pearl Award. 

Compiling with the Regulatory Requirement of the patient engagement process with pediatrics and their caregivers

Compiling with the Regulatory Requirement of the patient engagement process with pediatrics and their caregivers

There is a growing expectation from regulatory agencies for sponsors to provide robust patient experience data that demonstrate the impact their drugs may have on the quality of life for paediatric patients and their caregivers.

This involves meaningful involvement of patients and their caregivers in research priorities, protocol design, and regulatory decision making . means sponsors must start working closely with the patient community, regulators, key opinion leaders and other stakeholders to develop robust methodologies for data collection and analysis, as well as having systems and processes in place to put that into practice. During this workshop we will aim to discuss the regulatory strategy and medical writing aspects of these expectations and some strategies to address these.

Sarah Milner

Dr Sarah Milner is an experienced clinical and regulatory medical writer. Over the last 15+ years, she has provided medical writing, training, and consulting services to the pharmaceutical industry. Sarah has particular interest in the rare disease space, especially in paediatrics, and is a passionate patient advocate.

Francesca Buttigieg

Ms Francesca Buttigieg is an experienced Regulatory Affairs Director with a demonstrated history of working in the pharmaceutical industry, and is skilled in Global Drug Development, Regulatory Requirements, and Regulatory Strategy.

Communicating with children and their families: Engaging patient expert feedback and new media approaches to improve paediatric informed consent forms and lay summaries

Communicating with children and their families: Engaging patient expert feedback and new media approaches to improve paediatric informed consent forms and lay summaries

Communicating clinical trial information to the public is inherently challenging, given the complexity of medical terminology, procedures, and risks. This challenge is magnified when explaining clinical trials to children, who require clear, age-appropriate information to understand their participation. It is an ethical imperative to ensure that children and their families are fully informed about the trials in which they are involved.

At Boehringer Ingelheim, we have implemented several strategies to address this issue. One effective approach is the use of a paediatric expert advisory board. This board reviews our informed consent forms for children (called “assent forms”) and provides valuable feedback, enabling us to refine these documents to be more comprehensible for young participants. Additionally, we have embraced new media solutions, such as comics and videos, to make informed consent forms and lay summaries more engaging and accessible for children.

In our workshop session, we will present aggregate results from the paediatric advisory board’s feedback. We will highlight specific areas of the assent forms that have been updated and improved based on this feedback. Furthermore, we will showcase examples of our paediatric comics and videos, which have been used to explain trial results in a child-friendly manner.

Participants in the workshop will have the opportunity to discuss and explore other industry approaches to enhancing the clarity and accessibility of clinical study information for children and their families. This session aims to foster a collaborative environment where medical writers can share best practices and innovative solutions for improving paediatric clinical trial communication.

Karen Hinkle, Boehringer Ingelheim, USA

Dr. Karen Hinkle has been a medical writer with the Lay Language & New Media team at Boehringer Ingelheim for 2.5 years. Previously, she was a biology professor, researcher, and administrator at Norwich University, a comprehensive liberal arts academic institution in Vermont, USA. It was as a biology professorship where Karen’s passion for deconstructing technical information to plain language was born. At Boehringer, Karen continues this work through developing regulatory plain language documents for clinical trials, including lay summaries, informed consent forms, paediatric assent forms, lay protocol synopses, brief summaries, and others. She also oversees the development of the company-wide plain language glossary. Karen is an active member of AMWA and presented information about the glossary at the national conference in October, 2024, in New Orleans, LA, USA.  

Sebastian Florescu, Boehringer Ingelheim, Germany

Dr. Sebastian Florescu is also a Lay Language & New Media Medical Writer at Boehringer Ingelheim, where he has worked for about 4 years. With a PhD in cancer biology from the German Cancer Research Institute, Sebastian combines his scientific expertise with a passion for plain language writing and visual communication. He authors lay regulatory documents, including brief summaries, lay protocol synopses, informed consent forms, and lay summaries of study results. Sebastian is dedicated to making complex scientific information accessible and engaging for patients and the public. He also supports the development of digital solutions that enhance clinical development and communication. An active member of EMWA, Sebastian is committed to improving the clarity and accessibility of clinical trial information through innovative approaches.

Panel Discussion

Panel Discussion

Begoña Nafría, Head of patient engagement in research at SJD Children’s Hospital, Spain

Begonya Nafria is Head of Department at Sant Joan de Déu Chidren’s Hospital (Spain). She has long experience in the field of patient and family involvement in research initiatives. She has also a personal story as a caregiver and patient advocate because she is the sister of an adult with cerebral palsy.

Her areas of expertise are paediatric patient involvement in research, and specifically in the field of clinical trials. She is currently a PhD student focusing on children’s rights with respect to their participation in clinical studies.

Other relevant background of Begonya’s profile includes: Fellow of EUPATI (first cohort), Coordinator of eYPAGnet (European Young Patients Advisory Group Network – www.eypagnet.eu), Coordinator of Kids Barcelona (www.kidsbarcelona.org), member of Children’s Medicines Working Party of EFPGCP, chair of the working the working group of cross-border access to clinical trials at EmprEMA, and member of the EUPATI Board.

Coordinator of the cross-cutting theme of patients’ involvement in Conect4Children project (pan-European paediatric clinical trials network).

Bojana Mirosavljevic, ZIVOT (LIFE) Patient Organisation, Serbia & Balkan Region

Bojana Mirosavljevic is the Director of Patient Advocacy Strategy at ICON, and has 15+ years of Rare Disease Patient Advocacy Strategy experience focused on the clinical development process. Bojana has extensive experience in creating and implementing Patient Advocacy strategies for rare diseases in pharma and contract research organisations (CROs). Bojana is a chemist and embryologist specialised in pre-implantation genetic testing (PGT). 

Bojana is the Founder and President of ZIVOT (LIFE), a Patient Organisation operating in Serbia and the Balkan region. She successfully lobbied for Zoya’s law, which increased access to early diagnostic and newborn screening in Serbia.  She is a certified EUPATI Patient Expert for Rare Diseases and was a recipient of the prestigious EURORDIS Black Pearl Award. 

Sarah Milner

Dr Sarah Milner is an experienced clinical and regulatory medical writer. Over the last 15+ years, she has provided medical writing, training, and consulting services to the pharmaceutical industry. Sarah has particular interest in the rare disease space, especially in paediatrics, and is a passionate patient advocate.

Francesca Buttigieg

Ms Francesca Buttigieg is an experienced Regulatory Affairs Director with a demonstrated history of working in the pharmaceutical industry, and is skilled in Global Drug Development, Regulatory Requirements, and Regulatory Strategy.

Karen Hinkle, Boehringer Ingelheim, USA

Dr. Karen Hinkle has been a medical writer with the Lay Language & New Media team at Boehringer Ingelheim for 2.5 years. Previously, she was a biology professor, researcher, and administrator at Norwich University, a comprehensive liberal arts academic institution in Vermont, USA. It was as a biology professorship where Karen’s passion for deconstructing technical information to plain language was born. At Boehringer, Karen continues this work through developing regulatory plain language documents for clinical trials, including lay summaries, informed consent forms, paediatric assent forms, lay protocol synopses, brief summaries, and others. She also oversees the development of the company-wide plain language glossary. Karen is an active member of AMWA and presented information about the glossary at the national conference in October, 2024, in New Orleans, LA, USA.  

Sebastian Florescu, Boehringer Ingelheim, Germany

Dr. Sebastian Florescu is also a Lay Language & New Media Medical Writer at Boehringer Ingelheim, where he has worked for about 4 years. With a PhD in cancer biology from the German Cancer Research Institute, Sebastian combines his scientific expertise with a passion for plain language writing and visual communication. He authors lay regulatory documents, including brief summaries, lay protocol synopses, informed consent forms, and lay summaries of study results. Sebastian is dedicated to making complex scientific information accessible and engaging for patients and the public. He also supports the development of digital solutions that enhance clinical development and communication. An active member of EMWA, Sebastian is committed to improving the clarity and accessibility of clinical trial information through innovative approaches.

8:45 am - 10:15 am

Empowering Patients in Risk Mitigation: Bridging Theory and Practice in Clinical Pharmacy – EDG

Risk mitigation strategies (RMS) are essential for enhancing patient safety and ensuring effective healthcare delivery. However, their success depends on translating theoretical frameworks into practical, patient-centered interventions. Patient empowerment has been increasingly recognised as a crucial dimension of healthcare, improving patients’ understanding and control over their health and care processes. The World Health Organisation (WHO) has emphasised that patients’ active role and involvement in their care are essential for enhancing patient safety.
This presentation explores the integration of patients in RMS, focusing on the hospital pharmacist’s role in bridging theory and clinical practice. It will address critical questions, such as whether patients are involved in shaping, implementing, and evaluating RMS, and if not, why. Strategies for patient involvement range from providing information and education (e.g., brochures, surveys, peer support groups) to engaging patients in feedback and evaluation through tools like incident reporting systems and structured interviews. Examples will include practical approaches like medication reconciliation to reduce adverse drug events (ADEs), timely communication about medication changes to increase adherence, and the use of the teach-back method to ensure understanding of new medications or skills, such as inhaler techniques or subcutaneous injections.

Challenges, including the lack of patient input, delayed follow-ups, and limited resources, will also be discussed, along with solutions to overcome these barriers. Attendees will gain insights into how pharmacists can engage patients through consultation, advocacy, and collaboration, ensuring RMS are patient-friendly and effective. This session aims to inspire healthcare professionals to prioritise patient involvement as a key component of RMS to improve outcomes, enhance adherence, and foster safer healthcare systems.

Participant profile: Expert Discussion Groups (EDGs) are group discussions led by a moderator/moderators and the moderators will pose 2-3 questions ahead of the discussion on one topic to lead the discussion or to bring the discussion back to topic. There will be a max of 10 attendees, and we ask the moderators to set experience levels to keep the discussion standards and the level high. These sessions will be 1.5 to 2 hours.

Rita Martins PharmaD MSc, Tallaght University Hospital, Ireland

Rita is a clinical pharmacist at TUH with extensive experience in both primary care and hospital settings, with a strong focus on patient-centred care. She has a proven track record of collaborating with multidisciplinary teams to optimise medication use, enhance patient safety, and improve healthcare outcomes. Passionate about empowering patients, Rita is dedicated to providing education and fostering engagement, ensuring that patients and/or caregivers are actively involved in their healthcare journey.

 

8:45 am to 12:30 pm

LWA11a Tense

Provide guidance for medical writers who are not native speakers of English on the effective use of tense in English scientific and medical texts.

Participant Profile: This workshop is targeted towards medical writers whose native language is not English. Native speakers who encounter difficulties with the use of tense or who need to be aware of the difficulties experienced by non-native English writers in this area are also welcome.

Johanna Chester

Johanna M Chester is an independent freelance medical and scientific writer. She has co-authored over 75 publications in indexed journals in various disciplines, including surgery, dermatology, nephrology, urology, haematology, biomedical sciences and laboratory medicine. She teaches medical writing to doctors and aspiring medical writers in Italy. Johanna actively supports EMWA initiatives,  as a member of the EPDC,  co-lead of the webinar programme, member of the freelance business group, and a founder of the Italian LEG.

DDF 33 & 34B – Clinical Study Reports: Mastering the Essential Skills (Double workshop)

The objective of this workshop is to equip you with the essential skills required for the management and preparation of high quality clinical study reports (CSRs). This includes in-depth sessions on both the writing of CSRs as well as their project management. The workshop will include group exercises and discussions so that participants can develop the new skills they attained and learn from each other’s experiences. This double workshop brings together different aspects of knowledge and medical writing skills required (covered in depth in other workshops) for the production of CSRs.
Participant profile: This course is intended for medical writers with no or little experience of writing CSRs.
Gaele Ducher

Gaele is a principal medical writer and manager at Veristat. She worked in academic research for 10 years, in France, the UK, Australia, and the US, with a specific interest in rheumatology, paediatrics, medical imaging, and sport sciences. Gaele has a doctoral degree in physiology and published approximately 30 scientific articles during her research career. She has been a medical writer since 2011 and is experienced at writing a wide range of regulatory documents and medical communications covering various therapeutic areas

Arine Kassabian

Arine is a senior medical writer at Veristat. She has a PhD in sports sciences and has worked in academic research. She has been a medical writer since 2021 and is experienced at writing a wide range of regulatory documents on pharmaceuticals and medical devices, covering various therapeutic areas. Arine has also mentored medical writers on several types of documents.

DDA31 Orphan Medicinal Drug Products

To provide participants with an understanding of how to prepare the scientific part of an orphan designation application and to recognise strategies used in clinical development of an orphan medicinal product.
Participant profile: This workshop will benefit medical writers who have an interest in the clinical development of orphan medicinal products, and who are familiar with the European Medicines Agency marketing authorisation application (MAA) procedures. Prior attendance to DDF13 Basic Concepts of Study Design in Clinical Development would be helpful but is not essential.
Cheryl Roberts

Cheryl is currently the head of the global medical writing group for BioMarin, and specialises in medical writing for serious and life‑threatening rare diseases. She joined the pharmaceutical industry in 2001 in drug development, and continued in positions in medical editing and medical writing in both the pharmaceutical and consultancy industry. She holds a degree in Medical Biology and a Masters in Neuroscience. Cheryl has been a workshop leader since 2015.

DDA20 Risk Management Plans: Challenges and insights

To deepen and apply knowledge about regulatory requirements and guidance for the Risk Management Plan (RMP). At the end of the workshop, participants will be able to identify the right format and content for each section and deal with some major challenges of RMPs.
Participant profile: Aimed at medical writers with some experience of writing risk management plans (RMPs) or other safety documents (e.g. Periodic Safety Update Reports), or who have attended the foundation workshop on RMPs (the latter may be helpful for those with no experience of RMPs). Participants may also find the workshop “Introduction to Pharmacovigilance writing” (DDF32) helpful.
Tiziana von Bruchhausen

Tiziana has been specialising in pharmacovigilance (PV) writing since 2008. In her current position at Boehringer Ingelheim, she is responsible for the preparation of lifecycle PV documents with a particular focus on Risk-Management Plans (RMPs) and Periodic Safety Update Reports (PSURs), including related pre- and post-submission activities and health authority assessment reports. Tiziana has been a member of EMWA since 2009 and a workshop leader since 2013; she was President elect in 2017-2019 and has been chairing the PV special interest group since 2017.

MCF7c Targeting your Audience

The primary goal of writing is to convey information to a target audience. This workshop will explore the fundamental concepts of how a writer can express the same story to vastly varied audiences. The workshop and the post-workshop assignment will introduce, actively explore, and exercise the different writing styles commonly used in medical writing, emphasising which style is most effective for each audience, and why. Participants will learn and develop one of the fundamental principles of good writing: recognise who you are writing for and write for them.
Participant profile: Anyone who wants to develop their fundamental writing skills by building on the philosophy of writing and the writer’s role in expressing an idea in many ways. Anyone interested in gaining some practical insight into areas of writing (from public relations to regulatory) they may not encounter on a daily basis.
Julia Forjanic Klapproth

Julia is a Senior Partner of Trilogy Writing & Consulting, a company specialized in providing regulatory medical writing. Since she started her career as a regulatory medical writer in 1997, she has since been President of the European Medical Writers Association (EMWA) twice and is currently a member of the Executives Council for the American Medical Writers Association (AMWA). Julia is a known voice in the industry as an advocate for the importance of medical writing, writing and speaking frequently about the value of good medical writers during drug development. She is an experienced training of medical writers, running workshops for EMWA, AMWA, DIA, and pharmaceutical companies around the world. She is a Nick Thomson Fellow of EMWA and in 2022 she received the AMWA Harold Swanberg Distinguished Service Award for her contributions to medical communication.

Lisa Chamberlain James

Lisa is a Senior Partner of Trilogy Writing & Consulting. Aside from management activities, she leads client projects, with extensive experience in a variety of documents. Lisa has a special interest in writing for the public, and in the effective and ethical use of AI in medical writing. Following a PhD and post doc. in Pathology at Cambridge, Lisa began her medical writing career in 2000. Since then, she has been involved in the European Medical Writers Association (EMWA) as a member of the Educational Committee, mentor, leader, and assessor of workshops, and is a member of the American Medical Writers Association (AMWA)’s Executive Forum, AI Task Force, and teaches and reviews workshops for AMWA. Lisa regularly takes part in podcasts, articles, and is a member of several global, pan-industry panels and committees. She holds an EMWA professional development certificate, is a visiting lecturer for King’s College London and the University of Lisbon, initiated and chaired EMWA’s first Special Interest Group (in PV) and is the current chair of the Communicating with the Public SIG, and the Geoff Hall Scholarship Committee. She is section editor of the ‘Medical Communications and Writing for the Public’ section of Medical Writing, is an EMWA Nick Thompson Fellow, and a Fellow of the Royal Society of Medicine.

NEW MSF17 Oncology Essentials for Medical Writers

To equip medical writers with essential skills for oncology studies, the workshop aims to cover the principles of oncology diagnosis and therapy, relevant drug development guidelines, and their application in document drafting. Given the complexity of oncology trials, which involve intricate designs, diverse drug actions, varied patient populations, and specific objectives and endpoints, understanding these aspects is crucial.
Participant profile: This workshop is designed for medical writers with limited or no experience in oncology. Participants should have a general understanding of clinical study designs, ICH-GCP guidelines, and basic clinical trial statistics.
Ekaterina Weith

Ekaterina, a trained biologist, began her journey in Oncology drug development in 2005. Ekaterina brings experience in Medical Writing, Medical Data Review and Clinical Sciences. Her career includes leadership roles in biotech companies and contract research organizations, where she developed internal Oncology training programs. Ekaterina holds a Master’s degree in Pharmaceutical Medicine and is currently pursuing her PhD. At Immatics, she is part of Clinical Sciences team focusing on innovative TCR-based anticancer therapies.

PTA16 Oral Presentations: Skills to Help You Survive or Even Shine

What you need to know before preparing slides
Managing equipment and the environment.
Rehearsing and keeping to time.
Increasing the impact of an oral presentation.
Presentation nerves.
Voice and body language.
Questions and difficult people.
Individual participant presentations.
Important
Each participant will deliver a short presentation (3 minutes) with up to 10 slides prepared during the pre-workshop assignment. Participants and workshop leader will give constructive feedback
The workshop is limited to 10 participants, allowing comfortable time for all presentations and feedback.
For those who are worried – don’t be – you’ll be safe and it’s fun!
Participant profile: This workshop is suitable for medical writers who have some experience in delivering oral presentations and want to reflect on or improve their oral presentation skills. Participants should find the workshop useful for a variety of situations: presentations to colleagues, pitching to potential clients for new business, training colleagues, or speaking at meetings. Participants should be confident communicating in English, particularly as they will deliver a short presentation in English. (We do not cover slide design and construction of a story, which is addressed in the workshop Developing Effective Oral Presentations, MCF22.)
John Dixon

John qualified in medicine having studied at Oxford University and Guy’s Hospital, London. Initially he trained as a surgeon. After gaining further experience in paediatrics, neonatology, obstetrics and gynaecology, he then became a GP. Since 2003, John has completed an MBA at Warwick University Business School. He then spent five years as Director of Medical Communications at InterComm International Ltd., becoming a healthcare communications consultant and trainer in scientific communications in 2013. His interests include supporting researchers, medical communications agencies and medical equipment companies to ensure their scientific communications are accurate, understandable and use appropriate language. John has provided training for universities and research institutes across Europe in academic writing, presentation delivery, and conference abstract and poster preparation. He is co-author of How to Publish in Biomedicine. 500 Tips for Success. 3rd Edition (2016). CRC Press.

PTF25b What Medical Writers Need to Know About Patient Registries

To present the pros and cons of real-life research, to teach how to avoid over-interpretation of the study results, and how to present these data effectively. Finally, to position patient registries as a complement to experimental studies as a source of medical information.
Participant profile: This workshop addresses medical writers who prepare publications based on the data from research databases, patient registries and other real-life data sources. Basic knowledge of the design of observational studies, epidemiological research and statistics is not critical, but would be beneficial.
Adam Jacobs

After getting bored of his first two careers (organic chemistry research and medical translating), Adam worked as a medical writer, first at a small contract research organisation and then at a large medical communications agency. He set up his own business in 1999, which was a lot of fun for a while but sadly didn’t survive the recession and ceased trading in 2014. Adam was EMWA President in 2004–2005 and was co-author of EMWA’s guidelines on the role of professional medical writers in publications. He finally got bored of medical writing as well, and now works as a statistician. However, he doubts he will ever get bored of coming to EMWA conferences.

Maria Koltowska-Haggstrom

Maria is a co-owner of Proper Medical Writing, the first Polish medical writing agency. In 1991, she began working within the pharmaceutical industry where she gained experience in both the marketing and medical sides of the business. Between 2001 and 2013, Maria worked at Pharmacia (later Pfizer) in Stockholm, Sweden, where she was responsible for large research databases and patient registries. Maria led numerous research groups investigating growth hormone disorders based on real-life clinical data. She has an extensive track record of quality of life and patient-reported outcomes research. Furthermore, she lectured at different meetings related to late phase drug development and patient registries. She is a member of the European Medical Writers Association, European Association of Scientific Editors, European Society of Endocrinology, and Growth Hormone Research Society. She is also a reviewer for a number of peer-reviewed journals, an Associate Editor for BMC Endocrine Disorders and a section editor for Medical Writing. Maria was EMWA president in 2023-2024.

DDF38 CORE Reference Clarity and Openess in Reporting: E3-based

The current International Council for Harmonisation (ICH) guidance on clinical study report (CSR) authoring is ICH E3 (1995) and the 2012 Questions and Answers (Q & A) Revision document. Inconsistencies in interpretation require clarification, and indeed this is recognised specifically for ICH E3 in the 2012 Q & A document. CORE Reference (see http://www.core-reference.org/) launched on 03 May 2016, provides interpretational guidance on CSR authoring that incorporates regional (EU and US) and real-world insights. These include guidance on writing CSRs that share clinical trial data responsibly, and in accordance with current public disclosure requirements. Participants will acquire the knowledge and skills required to author or review fit-for-purpose CSRs that belong in the modern drug development arena.
Participant profile: Regulatory medical writers working in the contract research organisation or pharmaceutical company environment, as either employees or as freelancers, who write or review CSRs. The workshop will meet the needs of writers and reviewers in interpreting existing ICH guidelines that drive preparation of CSRs, and in ensuring that CSRs are written in accordance with the principles of responsible clinical trial data sharing. Participants must have written at least one CSR or reviewed several, and have working knowledge of ICH reporting guidelines.
Vivien Fagan

Vivien has 30 years of experience in an international pharmaceutical CRO. In her current position as Director, Global Medical Writing and Head of IQVIA’s Clinical Trial Disclosure group, Vivien manages a team of UK and European Medical Writers along with a group of Clinical Trial Disclosure Specialists based out of India. Vivien was a member of the EMWA-AMWA group who delivered the CORE Reference project (www.core-reference.org; an open access resource to support authoring of disclosure-ready CSRs).
Vivien is an EMWA Workshop Leader, DIA panellist and a member of The CORE Reference Project committee. In more recent years, Vivien has been an Expert Seminar Series (ESS) presenter on the topic of the EU CTR/CTIS.

Sam Hamilton

Sam Hamilton is a postdoctoral virologist, with 32 years in clinical and regulatory medical writing and leadership roles in the pharmaceutical industry. Sam has a special interest in public disclosure of clinical-regulatory documents as Chair of the EMWA-AMWA group who delivered the open-access www.core-reference.org in May 2016. Sam is long-time supporter of EMWA serving in various roles over 19 years, notably as Freelance Advocate; Editorial Board member for Medical Writing (MEW); Workshop Leader; Expert Seminar Series (ESS) Chair; and Vice President and President. Sam was elected an EMWA Nick Thompson Fellow in 2018 for her services to the Association. Sam is currently MEW Section Editor for the “Regulatory Public Disclosure” Section, and Chair of The CORE Reference Project.

12:30 am - 1:30 pm

Regulatory writing SIG lunchtime meeting

This session will take place in room Beta 1, Hall 1.

12:30 pm - 1:15 pm

GenAI in Action: Demo and Real-World Case Studies Automating Document Authoring for Regulatory Submissions and Scientific Reports in Top Global Pharma

1:30 pm to 5:00 pm

Organisers: Lisa Chamberlain James and Tiziana von Bruchhausen, CwP & PV SIG

The Communicating with Patients and Pharmacovigilance SIGs are excited to present a joint ESS on Wednesday 7th May titled: The Link Between Risk Mitigation and Patients – Where do they Fit In?

Join us for a deep dive into how patients are (or are not) involved in the clinical development process – specifically hearing from Patient advocates, Regulators, Pharmaceutical lawyers, and Medical Writers who will examine patients’ and the Pharma Industry’s roles and responsibilities when it comes to explaining the risks from medicines. How does this affect patients and industry, and how can we do better?

Clear Communication of Safety and Contraception Information in the Informed Consent

Clear Communication of Safety and Contraception Information in the Informed Consent

Informed consent is a cornerstone of ethical medical practice, ensuring that participants are fully aware of the risks and benefits associated with treatments in clinical research studies. This presentation explores the critical role of clear communication in conveying safety and contraception information within informed consent documents. We will examine regulatory and ethical frameworks, effective risk mitigation strategies, and practical communication techniques.

We will summarise the process of continuous safety updates within clinical development and demonstrate how Lay Language Medical Writers can extend this process to integrate regular safety updates into Informed Consent Forms. We will describe how to extract and convert relevant information for potential clinical study volunteers. Examples will be provided to illustrate how safety language can be simplified to be both acceptable to researchers and understandable to participants. Additionally, we will discuss the evolution of safety content from early investigational drugs to approved medicines on the market, including adjustments for communicating safety to children and adolescents.

By sharing feedback from patients, doctors, sites, and ethics committees, we will highlight the challenges of implementing clear communication of safety and contraception information. Attendees will gain insights into overcoming common challenges and implementing best practices to enhance patient understanding and decision-making.

Cornelia Weiss-Haljiti PhD, Boehringer Ingelheim, Germany

Cornelia Weiss-Haljiti is an Expert Medical Writer and a biochemist by training with a PhD in endothelial cell biology. For 10 years, she worked as a scientist leading projects and laboratories in academia, biotech, and pharmaceutical industry. Cornelia developed expertise in the discovery and validation of targets, drugs, and biomarkers.

In 2012, Cornelia joined Boehringer Ingelheim Pharma GmbH & Co. KG. to become a Medical Writer. She wrote regulatory documents across all phases and therapeutic areas. She holds the EMWA foundation and advanced certificate. Over time she became particularly interested in plain language writing, graphics, and design. She was the design lead of a digital platform to share lay summaries of study results with the public. Currently she leads and represents Informed Consent activities by the Lay Language & New Media Team, a specialised medical writing team within Boehringer Ingelheim.

 

Empowering Patients in Risk Mitigation: Bridging Theory and Practice in Clinical Pharmacy

Empowering Patients in Risk Mitigation: Bridging Theory and Practice in Clinical Pharmacy

Risk mitigation strategies (RMS) are essential for enhancing patient safety and ensuring effective healthcare delivery. However, their success depends on translating theoretical frameworks into practical, patient-centred interventions. Patient empowerment has been increasingly recognised as a crucial dimension of healthcare, improving patients’ understanding and control over their health and care processes. The World Health Organisation (WHO) has emphasised that patients’ active role and involvement in their care are essential for enhancing patient safety.

This presentation explores the integration of patients in RMS, focusing on the hospital pharmacist’s role in bridging theory and clinical practice. It will address critical questions, such as whether patients are involved in shaping, implementing, and evaluating RMS, and if not, why. Strategies for patient involvement range from providing information and education (e.g., brochures, surveys, peer support groups) to engaging patients in feedback and evaluation through tools like incident reporting systems and structured interviews. Examples will include practical approaches like medication reconciliation to reduce adverse drug events (ADEs), timely communication about medication changes to increase adherence, and the use of the teach-back method to ensure understanding of new medications or skills, such as inhaler techniques or subcutaneous injections.

Challenges, including the lack of patient input, delayed follow-ups, and limited resources, will also be discussed, along with solutions to overcome these barriers. Attendees will gain insights into how pharmacists can engage patients through consultation, advocacy, and collaboration, ensuring RMS are patient-friendly and effective. This session aims to inspire medical writers to prioritise patient involvement as a key component of RMS to improve outcomes, enhance adherence, and foster safer healthcare systems.

Rita Martins PharmaD MSc, Tallaght University Hospital, Ireland

Rita is a clinical pharmacist at TUH with extensive experience in both primary care and hospital settings, with a strong focus on patient-centred care. She has a proven track record of collaborating with multidisciplinary teams to optimise medication use, enhance patient safety, and improve healthcare outcomes. Passionate about empowering patients, Rita is dedicated to providing education and fostering engagement, ensuring that patients and/or caregivers are actively involved in their healthcare journey.

 

Communicating Drug Risks Without Scaring Patients: A Patient-Centred Approach (VIRTUAL PRESENTATION)

Communicating Drug Risks Without Scaring Patients: A Patient-Centred Approach (VIRTUAL PRESENTATION)

Patient-centred drug development has made huge leaps forward in recent years and an increasingly better-informed patient community is embracing shared-decision making as the norm when it comes to their healthcare. But how can we ensure that they are kept in the loop when it comes to conveying risk? Are we scaring patients with the current patient information leaflets? This presentation will cover why it is important to make patients part of the conversation, how to involve patients in developing materials that communicate risk, tips for effectively working with patients, and opportunities for the future. 

Trishna Bharadia MFPM (hon), Patient Advocate, UK

Trishna Bharadia is a multi-award winning patient engagement consultant and advocate with ~15 years of experience in the field. She works with multiple stakeholders, including pharma, medical communications agencies, publishers, academia, industry associations, and patient groups to better embed the patient voice into healthcare, research, and medicines development. Among various roles, she is a visiting lecturer in patient engagement at King’s College London, an Advisory Board member for the Patient Information Forum, a steering group member for Good Publication Practice (GPP), sits on editorial boards for several journals, and co-chairs the Working with Patients and Communities Forum at the Faculty of Pharmaceutical Medicine, where she is also an honorary member. Her main interests lie in good patient engagement practice and design/delivery of patient-focused projects; diversity, equity and inclusion in healthcare and research; and patient involvement in health information and scientific publications. A full list of her publications is available on ORCID.

 

 

Trust in Science: Under Assault!

Trust in Science: Under Assault!

There is evidence that confidence in science and associated sources of information has been eroding.  Many factors may be seen as having contributed to this alarming trend, resulting in difficulty in distinguishing integrity and reliability of information.

Some of this is self-inflicted, caused by fraud, misrepresentation, and unintended errors.  In some cases, desperate circumstances resulted in desperate measures, and in the context of a global health crisis (e.g., COVID-19), there were pressures which exacerbated these factors, fostering wild theories and science denialism through unfettered on-line platforms. 

We will discuss some of these factors and influences on the public perception of, and trust in empirical science. 

Art Gertel, MedSciCom, LLC

Art has a background in neurophysiology and behavioural medicine. As an independent consultant, he specialises in regulatory strategy, Data Safety Monitoring Board management, medical writing, and bioethics. Art has held senior posts at a number of companies including Schering-Plough/Merck, Hoffmann-LaRoche, TFS, and Quintiles, and headed departments responsible for medical writing, publications, project management, and regulatory affairs. He also served as a Senior Research Fellow with the Centre for Innovation in Regulatory Sciences (CIRS). Art has extensive teaching experience and has presented to professional organisations (e.g. EMWA, AMWA, DIA), and corporate and academic audiences, worldwide. He spent 2 years heading Clinical Operations for an eDC ‘dot.com’ company, and has been active in Clinical Data Interchange Standards Consortium (CDISC) since its inception. He served as Chair of the Global Ethics and Regulatory Initiative (GERI) of the Alliance for Clinical Research Excellence and Safety (ACRES). He is a Founding Member of the Global Alliance of Publication Professionals (GAPP), a Past President of AMWA, and a Fellow of both AMWA and EMWA. Art served in a Senior Advisory capacity on the Budapest Working Group in developing the CORE Reference. He has a particular interest in bioethics in the context of clinical studies, is an adviser to an IRB, and serves on a number of task forces focusing on improving the drug development process while protecting the rights and safety of clinical study participants.

 

Legal Perspective on Informed Consent Forms and Patient Information Sheets: Do They Really Have to Be So Long?

Legal Perspective on Informed Consent Forms and Patient Information Sheets: Do They Really Have to Be So Long?

Have you ever wondered why Informed Consent Forms (ICFs) and patient information sheets in clinical trials are so lengthy? Is this level of detail truly necessary? What legal requirements must be included, and could these be simplified without losing essential information?

This presentation aims to answer these questions by examining the legal landscape surrounding ICFs. It explores how these documents protect patient rights and ensure ethical conduct in clinical research. Additionally, it discusses the potential risks for patients, physicians, and sponsors if ICFs do not meet legal requirements or if these requirements are not clearly understood by patients.

Whether you find legal topics intriguing or typically avoid them, this session promises to provide valuable insights and practical knowledge that will enhance your understanding of the legal requirements for ICFs in the European Union and help you engage more effectively with legal advisers on this topic.

Franka Felsner, Boehringer Ingelheim Middle East & Africa GmbH

Biography

As a lawyer with extensive experience in the pharmaceutical industry, Franka Felsner is dedicated to helping her clients confidently and effectively navigate an ever-evolving regulatory landscape around the world. As Senior Legal Counsel at Boehringer Ingelheim, she provides expert legal support for all aspects of clinical development, with a particular focus on Informed Consent Forms in the European Union and beyond. Before joining Boehringer Ingelheim, Franka worked for an international law firm in London, Brussels, and Frankfurt, and holds a law degree from the University of Oxford.

 

Advancing medicines safety: EMA’s revised risk minimisation measures and the role of patient engagement

Advancing medicines safety: EMA’s revised risk minimisation measures and the role of patient engagement

In July 2024, the European Medicines Agency (EMA) issued its revised guideline on Good Pharmacovigilance Practices (GVP) Module XVI and its Addendum II. The update places greater emphasis on the involvement of healthcare professionals and patient representatives in the design, testing, dissemination of risk minimisation measures (RMMs), as well as the evaluation of their effectiveness.

While routine RMMs, such as the summary of product characteristics and package leaflet, can be sufficient to manage most risks for medicines, some may require the use of additional RMM tools. And although the selection and design of RMMs is a shared responsibility between medicines regulators and marketing authorisation holders, healthcare professionals and patients play a key role in ensuring that they are integrated and adopted into practice. By establishing processes to enhance the engagement of healthcare professionals and patients, the revised guideline aims to ensure that RMMs are scientifically robust, practical, and effective in everyday clinical practice.

This collaborative model underscores the critical importance of educating healthcare professionals and patients to drive change of behaviours and practices amongst clinicians and patients through integration in healthcare processes.

EMA has a longstanding history of involving patients in its core activities and integrating their perspectives, from scientific advice early in development, evaluation of marketing authorisation applications to post-authorisation activities. Enhancing the relevance and accessibility of safety information and improving patient outcomes can only strengthen the pharmacovigilance ecosystem.

Morgane De Verdiere, European Medicines Agency, NL

My name is Morgane De Verdiere and I am the head of the Medical and Health Information service better known within the European Medicines Agency as the Medical Writers team. 

I trained as a pharmacist in Paris and moved to the UK in early 2000 to work in Regulatory Affairs for a pharmaceutical company. I joined EMA in early 2006, working in the 

Committee for Medicinal Products for Human Use (CHMP) secretariat for several years. After a stint in our Access to Document service, I moved to my current role in 2019 where amongst other things I oversee all medicines-related content that we publish in lay language.

 At EMA, writing is a big part of our work and communicating clearly is a strength we cultivate and share internally. I am a strong believer that anyone can get better at writing clearly.

 

Panel Discussion

Panel Discussion

Cornelia Weiss-Haljiti PhD, Boehringer Ingelheim, Germany

Cornelia Weiss-Haljiti is an Expert Medical Writer and a biochemist by training with a PhD in endothelial cell biology. For 10 years, she worked as a scientist leading projects and laboratories in academia, biotech, and pharmaceutical industry. Cornelia developed expertise in the discovery and validation of targets, drugs, and biomarkers.

In 2012, Cornelia joined Boehringer Ingelheim Pharma GmbH & Co. KG. to become a Medical Writer. She wrote regulatory documents across all phases and therapeutic areas. She holds the EMWA foundation and advanced certificate. Over time she became particularly interested in plain language writing, graphics, and design. She was the design lead of a digital platform to share lay summaries of study results with the public. Currently she leads and represents Informed Consent activities by the Lay Language & New Media Team, a specialised medical writing team within Boehringer Ingelheim.

 

Rita Martins PharmaD MSc, Tallaght University Hospital, Ireland

Rita is a clinical pharmacist at TUH with extensive experience in both primary care and hospital settings, with a strong focus on patient-centred care. She has a proven track record of collaborating with multidisciplinary teams to optimise medication use, enhance patient safety, and improve healthcare outcomes. Passionate about empowering patients, Rita is dedicated to providing education and fostering engagement, ensuring that patients and/or caregivers are actively involved in their healthcare journey.

 

Trishna Bharadia MFPM (hon), Patient Advocate, UK

Trishna Bharadia is a multi-award winning patient engagement consultant and advocate with ~15 years of experience in the field. She works with multiple stakeholders, including pharma, medical communications agencies, publishers, academia, industry associations, and patient groups to better embed the patient voice into healthcare, research, and medicines development. Among various roles, she is a visiting lecturer in patient engagement at King’s College London, an Advisory Board member for the Patient Information Forum, a steering group member for Good Publication Practice (GPP), sits on editorial boards for several journals, and co-chairs the Working with Patients and Communities Forum at the Faculty of Pharmaceutical Medicine, where she is also an honorary member. Her main interests lie in good patient engagement practice and design/delivery of patient-focused projects; diversity, equity and inclusion in healthcare and research; and patient involvement in health information and scientific publications. A full list of her publications is available on ORCID.

 

 

Art Gertel, MedSciCom, LLC

Art has a background in neurophysiology and behavioural medicine. As an independent consultant, he specialises in regulatory strategy, Data Safety Monitoring Board management, medical writing, and bioethics. Art has held senior posts at a number of companies including Schering-Plough/Merck, Hoffmann-LaRoche, TFS, and Quintiles, and headed departments responsible for medical writing, publications, project management, and regulatory affairs. He also served as a Senior Research Fellow with the Centre for Innovation in Regulatory Sciences (CIRS). Art has extensive teaching experience and has presented to professional organisations (e.g. EMWA, AMWA, DIA), and corporate and academic audiences, worldwide. He spent 2 years heading Clinical Operations for an eDC ‘dot.com’ company, and has been active in Clinical Data Interchange Standards Consortium (CDISC) since its inception. He served as Chair of the Global Ethics and Regulatory Initiative (GERI) of the Alliance for Clinical Research Excellence and Safety (ACRES). He is a Founding Member of the Global Alliance of Publication Professionals (GAPP), a Past President of AMWA, and a Fellow of both AMWA and EMWA. Art served in a Senior Advisory capacity on the Budapest Working Group in developing the CORE Reference. He has a particular interest in bioethics in the context of clinical studies, is an adviser to an IRB, and serves on a number of task forces focusing on improving the drug development process while protecting the rights and safety of clinical study participants.

 

Franka Felsner, Boehringer Ingelheim Middle East & Africa GmbH

Biography

As a lawyer with extensive experience in the pharmaceutical industry, Franka Felsner is dedicated to helping her clients confidently and effectively navigate an ever-evolving regulatory landscape around the world. As Senior Legal Counsel at Boehringer Ingelheim, she provides expert legal support for all aspects of clinical development, with a particular focus on Informed Consent Forms in the European Union and beyond. Before joining Boehringer Ingelheim, Franka worked for an international law firm in London, Brussels, and Frankfurt, and holds a law degree from the University of Oxford.

 

Morgane De Verdiere, European Medicines Agency, NL

My name is Morgane De Verdiere and I am the head of the Medical and Health Information service better known within the European Medicines Agency as the Medical Writers team. 

I trained as a pharmacist in Paris and moved to the UK in early 2000 to work in Regulatory Affairs for a pharmaceutical company. I joined EMA in early 2006, working in the 

Committee for Medicinal Products for Human Use (CHMP) secretariat for several years. After a stint in our Access to Document service, I moved to my current role in 2019 where amongst other things I oversee all medicines-related content that we publish in lay language.

 At EMA, writing is a big part of our work and communicating clearly is a strength we cultivate and share internally. I am a strong believer that anyone can get better at writing clearly.

 

1:30 pm - 3:00 pm

Writing with the paediatric population in mind – EDG

This workshop is aimed at medical writers who work in paediatric healthcare. We will discuss the recent updates to the E11a and share experiences on paediatric protocol design to optimise engagement and retention while being mindful of the specific ethics and vulnerabilities we encounter. Have we yet embraced AI as a tool to optimise our patient‑focused materials in clinical trials and the context of the general medicine environment?
We would like this EDG to be an opportunity to share our experiences working for the paediatric population, including what has worked and what has not.
Participant profile: Expert Discussion Groups (EDGs) are group discussions led by a moderator/moderators, and the moderators will pose 2-3 questions ahead of the discussion on one topic to lead the discussion or to bring the discussion back to topic. There will be a max of 10 attendees, and we ask the moderators to set experience levels to keep the discussion standards and the level high. These sessions will be 1.5 to 2 hours.
Heather L. Mason

Heather worked in both clinical operations and medical affairs departments for eight years before turning to medical writing in 2010. She has been a freelance writer since 2018, working in a wide range of therapeutic areas for pharma, biotech, not-for-profit, and patient organisations. Her specialist area of interest is rare diseases, and she writes predominantly in medical communications, ranging from conference coverage and manuscripts to patient-focused materials and whole project management. Since working on rare diseases and having a son with a disability, she has a passion for patient advocacy, understanding first-hand how non-inclusivity can adversely affect the day-to-day lives of people.

1:30 pm to 5:00 pm

MCF34 The art of storytelling through infographics

The ability to communicate scientific and medical topics visually gives any medical writer an advantage and a chance to collaborate on a variety of projects and improve their portfolio. Given the emergence of new technologies, it is important to gain tools that cannot be easily replaced by AI. Infographics and complex displays of information including images are not yet easily achieved by this type of technology, positioning medical writers with visual communication skills in a more competent place.
Participant profile: This workshop is designed for anyone in medical writing who wants to improve their skills in visual communication using infographics. No previous knowledge or workshop is required, some experience in design would be helpful but is not essential. There’s no need to buy any license as we will work with free online tools.
Evguenia Alechine

Evguenia finished her PhD in biochemistry at the University of Buenos Aires before finding her true passion in science communication. At EMWA, she is the co-editor of the Medical Writing journal and chair of the GIMW Programme Committee. She is a passionate educator with 15+ years of teaching experience. She is currently a freelance science communication lecturer, a career coach, and a founding partner at Alquimia CMC.

Sofia Polcownuk

Sofia Polcowñuk has a PhD in Biology from the University of Buenos Aires and is currently a researcher at the University of Glasgow where she discovered her passion for science communication through illustrations. She joined EMWA 3 years ago and is an active member of the Creative Team. With over 8 years teaching experience in different modalities, Sofia is currently working as a freelance illustrator for ChemDye studio and is passionate about visual communications and design.

MDF11 Introduction to Medical Devices

To give attendees an overview of what a medical device is, the classification rules, regulatory landscape (focusing primarily on the European Union), and the main documents that medical writers are involved with. The workshop will also explore the role of the medical writer, the necessary skills and possible challenges to overcome when working in the medical devices area.
Participant profile: new/aspiring medical writers who are interested in writing for medical devices, or experienced medical writers, who usually work in medical communications or in regulatory (drug development) and want to learn about medical devices. This is an introductory workshop, so the only ones who will not benefit from it are those who already work in medical devices and have an understanding of the processes and documents involved.
Diana Ribeiro

Diana Ribeiro, MPharm, is a pharmacist by training. Having worked for 10+ years in hospital and community pharmacies, she then transitioned to medical writing in late 2019. Working across a number of therapeutic areas, she has written many different types of documents, both in medical communications and the regulatory field. In 2020, she started working in medical devices, authoring clinical evaluation reports under the medical devices directive and the medical devices regulation (MDR), as well as other documents in this area.

LWF8 Sharpen up your Writing Skills

The objective of the course is to help participants write clear, professional text that communicates effectively with their target audience. We will focus on writing for scientific/technical/medical audiences and touch on aspects of writing for patients and the general public. The skills taught are applicable to all types of written communication.
Participant profile: This workshop will be useful for anyone who wants to make their writing more effective.
Jo Whelan

Jo has over 25 years’ experience in medical writing, and is currently Value Communication Principal at Visible Analytics Ltd. She specialises in writing for market access, health economics, and outcomes research. She has led, managed, and written a wide variety of projects for pharmaceutical companies, market access consultancies, and medical communications agencies, including health technology assessment submissions, value stories, manuscripts, literature research projects and more. In a previous life, she has written numerous news and feature articles for the scientific and consumer health press, and is author of four health-related books for teenagers. She has a particular interest in oncology and holds an MSc in Cancer Therapeutics from Barts Cancer Institute, Queen Mary University of London. Jo served as EMWA Education Officer from 2011 to 2014.

PTA-19: Regulatory Writing: the Medical Writer as the Leader and Manager

This workshop will detail and enhance stakeholder management and resource management within project teams when the Medical Writer (MW) is considered the lead in the production process. MWs will be in a position to better manage the projects that they are leading or resourcing following this workshop.
Participant profile: This workshop is beneficial for Medical Communicators/MW who lead in project development, resource for specific documents, possibly still author, or manage teams and resource tasks within those teams. Participants should have experience in leading projects, departments, teams or with the potential of moving into that role.
Sarah Choudhury

Sarah has been a medical writing professional since she graduated with a doctorate in the biological sciences from University College London. Currently, she is a Director in clinical regulatory writing at AstraZeneca. She manages one of the established portfolios in the oncology franchise. There she is a also a submission lead overseeing dossiers for IND/CTAs, MAAs/BLAs. In addition to authoring key clinical documents, she is also a line manager of 5 reports. Previously, she has worked in CROs, other pharmas, also as a manager and lead author. She had a brief stint in medical devices, and as a freelancer. She is actively involved in EMWA: She served on Executive Committee as Treasurer and Honorary Secretary, led an EMWA workshop, EMWA webinar, and published in Medical Writing (including recently, the Salary Survey). She is currently part of the Treasurer’s Finance Committee, an EMWA ambassador, and a member of the Remuneration Survey team.

MCF17a Using Writing Guidelines

The growing availability of guidelines and checklists makes identification and use of the most appropriate guidelines for any specific disclosure more difficult. This workshop will help the writer to identify what is available and understand how to choose and use the most appropriate guidelines for their purpose.
Participant profile: As professional medical writers should be reporting guideline champions, this workshop is propaedeutic for any workshops publishing in scientific journals or at congresses, and highly helpful for regulatory writers.
Andrea Rossi
Andrea Rossi is a Florence biologist who has been in clinical research for over 35 years. He has been an EMWA member since 2004 and was on the coordination board of BIAS (Biometristi Italiani Associati) from 2007–2009. Andrea is a trainer for statistics and medical writing in some Italian Universities and schools for specialization in medicine. He is an EMWA Ambassador, is a member of several Special Interest Groups, has developed the EMWA salary surveys, is leading the Italian Local EMWA Group, and is a workshop leader and past president of EMWA.

MCA4 Manuscript Writing: from Good to Excellent

To increase the likelihood of producing focused – on a clear purpose statement – coherent research papers with well-structured in-depth argumentation.
Participant profile: Participants should have some experience with writing scientific papers. The workshop is relevant for those who write or edit papers for others, and for those who wish to improve their own papers.
Kari Skinningsrud

Kari is an experienced freelance medical writer who works mainly with medical communication and training, particularly manuscript writing. She has given workshops on manuscript writing at several universities in different countries, gives EMWA workshops on manuscript writing, grant-writing and cross-cultural communication, and currently serves on EMWA’s Professional Development Committee (since 2013). During 2004–09 she was a member of EMWA’s Executive Committee. She is bilingual Canadian/Norwegian, has a MSc in biochemistry, has worked for more than 10 years in clinical development in pharmaceutical industry, and is currently a regular writing consultant for a medical device company.

PTA10 Effective Reporting of Scales, Questionnaires and VAS

This workshop explains the use of assessments in treatment outcomes that cannot easily be measured objectively. Typical examples are patient or physician questionnaires and visual analogue scales. These are often used in psychiatry, pain studies, or quality of life research where objective measurements are not possible or difficult. The reporting of these “soft endpoints” has some pitfalls, often providing a huge amount of data that is difficult to analyse, interpret, and communicate. Given the growing importance of psychiatry and patient focused quality of life research, reporting outcomes of subjective scales and questionnaires are becoming more and more important for medical writers.
Participant profile: This workshop addresses writers dealing with or interested in areas of clinical research, such as psychiatry, pain, quality of life, or patient reported outcomes, where “soft” endpoints are often used to assess treatments. Participants should have at least 1 year of medical writing experience and should already have written a study report or a manuscript based on the results of clinical studies.
Thomas Wagner

Thomas is a biologist by training and was working hard to unravel the mysteries of the brain using his own brain and such obscure things as glass needles, fluorescent dyes and white powders called neurotransmitters. However, in order to avoid going mad himself, he quit university and started his medical writing career in 1999 with the CRO Kendle in Munich. In 2002 he changed to big pharma and worked for Lilly Deutschland GmbH, mainly writing on Phase III-IV projects, including observational studies. Still working in the area of madness he mostly tackled psychiatry, quality of life, and red tape in the position of Group Leader Scientific Communications Europe for Neurosciences at Eli Lilly & Co. To avoid getting entangled too much he then changed in 2009 to the other side of the fence now working as a service provider and consultant for Trilogy Writing & Consulting as Medical Writing Manager. In 2015 Thomas moved to the headquarters of Merck Healthcare KGaA in Germany and is responsible for all regulatory medical writing documents from Phase I to post-marketing studies in the “beyond oncology” area; including the setup of a MW hub in Bangalore/India.

NEW PTF43 Optimizing writing efficiency by taking advantage of Microsoft Word’s hidden options

Attendees will learn how to organize their most-used commands for easy access, to apply keyboard shortcuts that are useful for their writing needs, to more efficiently create and revise tables, and to create standardized styles. Each topic will be introduced in a short lecture with class participation, followed by a hands-on exercise and group discussion.
Participation profile: This workshop is intended for medical writers with basic to intermediate skills in Microsoft Word who want to become more efficient at using Microsoft Word in their jobs. There are no prerequisites for this workshop.
Jacqueline Janowich Wasserott

Dr. Janowich Wasserott is a Senior Medical Writer on the Publications and Scientific Communications team of the PPD clinical research business of Thermo Fisher Scientific. She is the leader of the ‘Tech Tips’ focus group, where she provides departmental trainings on practical tips to improve writing efficiency using Microsoft Word, Excel, and PowerPoint. Before becoming a medical writer, Dr. Janowich Wasserott studied how the brain handles the demands of task switching and task planning. She has a keen interest in improving processes and enjoys finding new ways to elevate the quality and efficiency of writing deliverables.

DDF 33 & 34B – Clinical Study Reports: Mastering the Essential Skills (Double workshop)

The objective of this workshop is to equip you with the essential skills required for the management and preparation of high quality clinical study reports (CSRs). This includes in-depth sessions on both the writing of CSRs as well as their project management. The workshop will include group exercises and discussions so that participants can develop the new skills they attained and learn from each other’s experiences. This double workshop brings together different aspects of knowledge and medical writing skills required (covered in depth in other workshops) for the production of CSRs.
Participant profile: This course is intended for medical writers with no or little experience of writing CSRs.
Gaele Ducher

Gaele is a principal medical writer and manager at Veristat. She worked in academic research for 10 years, in France, the UK, Australia, and the US, with a specific interest in rheumatology, paediatrics, medical imaging, and sport sciences. Gaele has a doctoral degree in physiology and published approximately 30 scientific articles during her research career. She has been a medical writer since 2011 and is experienced at writing a wide range of regulatory documents and medical communications covering various therapeutic areas

Arine Kassabian

Arine is a senior medical writer at Veristat. She has a PhD in sports sciences and has worked in academic research. She has been a medical writer since 2021 and is experienced at writing a wide range of regulatory documents on pharmaceuticals and medical devices, covering various therapeutic areas. Arine has also mentored medical writers on several types of documents.

Thursday, 8th May, 2025

7:45 am - 8:30 am

English breakfast’ Round table session

English breakfast’ Round table session with Johanna Svanberg.

In this session, we’ll explore the realms of hyphens, articles, and serial commas. Whether English is your first language or you’re navigating it as a foreign language, come share your thoughts, ask questions, and gain insights into the nuances of English grammar. Feel free to grab some breakfast and bring it with you!

Johanna Svanberg

Johanna Svanberg studied physical chemistry in the UK. After finishing her DPhil, she worked as a freelance science writer and editor before turning to regulatory medical writing in 2022. Johanna currently works for Optimapharm.

7:45 am - 8:30 am

Round Table Session: The MDR and lay language: working together to create lay summaries on SSCPs in a medical device company

In this roundtable session, a medical writer and a regulatory writer will cover the collaborative steps in successfully producing lay language summaries for medical devices for submission to notified bodies. Special attention will be given to searching for best practice and addressing remaining challenges.

Michael Todd

Team Leader, Medical Writing at MED-EL Medical Electronics (Innsbruck, Austria)

Michael Todd has been working on manuscripts for MED-EL since 2011 and has been a team leader since 2021. Prior to working in medical writing, he taught English as a foreign language in Poland, Czechia, and Slovakia. Unusually for a medical writer, he comes from the humanities rather than the sciences (B.A. in English Literature, McGill University, Montreal). Originally from Detroit, Michigan, he lived in 6 countries before settling in Austria in 2011. He has assisted in writing/editing over 100 peer-reviewed publications.

CwP (Communicating with the Public Special Interest Group)

Med Coms SIG

Katharina Angerer-Klaunzer

Clinical Evaluations Manager at MED-EL Medical Electronics (Innsbruck, Austria)

Katharina Angerer joined MED-EL as a Clinical Evaluations Manager/Regulatory Writer in 2022. She prepares regulatory documents (e.g., CEP, CER and SSCP) for submission to notified bodies. Katharina is a molecular biologist by training. Before joining MED-EL, she worked in basic and translational research in immuno-oncology.

7:45 am - 8:30 am

Round Table Session: Cross-publisher plain language article guidance: have your say

Plain language summaries of publications (PLSPs) help to democratize scientific knowledge. These standalone summaries of original research articles are written in an easy-to-understand language and are published open access, making them accessible to a diverse readership. Despite these benefits and increasing support of pharma companies, healthcare professionals and patient advocates for PLSPs, only three publishers to date offer this article type in at least some of their journals.

Sarah Griffiths

Sarah Griffiths, PhD is Communications Director of the Patient Engagement Team at Oxford PharmaGenesis. She is an experienced medical communications and publications professional, with expertise and a passion for plain language deliverables and health literacy. She is a member of numerous professional associations, has presented at congresses and peer reviews plain language summary publications.

8:45 am to 5:00 pm

Organisers: Raquel Billiones, Anne Paulussen, Cherry Malonzo Marty, Jules Kovacevic MD-SIG, Regulatory-SIG

Introduction: Why Combination Products are Important in Healthcare

Introduction: Why Combination Products are Important in Healthcare

Raquel Billiones
Raquel Billiones (PhD in Biology) is a (she/her) subject matter expert in Clinical Research, Development & Regulatory Strategy, Regulatory Medical Writing for Pharma/Medical Devices/Combination Products, and Data Disclosure/Protection. She has been a regulatory writer for almost 20 years, covering both pharmaceuticals and medical devices. Her core competencies include clinical trials and marketing authorisation submission documents, data disclosure and protection, and project and people management. Over the years, she took on a wide range of industry positions, as freelancer, as employed regulatory writer, and leadership roles in CROs and big pharma settings. She is currently employed at Johnson & Johnson Innovative Medicine. Her current role is Director of Medical Writing for Medical Devices and Combination Products at Alexion (AstraZeneca Rare Disease Unit).
Raquel is an active EMWA member since 2006 serving in various roles. She co-founded the EMWA Medical Device SIGs and co-leads several EMWA regulatory workshops on medicinal products, medical devices, and combination products. She is currently the editor-in-chief of the EMWA journal Medical Writing and a member of the EMWA Executive Committee.
Navigating Combined Studies: The COMBINE Initiative and EMA’s Role

Navigating Combined Studies: The COMBINE Initiative and EMA’s Role

Facilitating the development and authorisation of medicines used in combination with medical devices including companion diagnostics is a key priority for the EU regulatory network.

As innovative treatments increasingly integrate medicinal products with medical devices or in vitro diagnostics, navigating the different regulatory frameworks has become more challenging.

The COMBINE project aims to address the challenges sponsors face in navigating the regulatory interface between the regulations for clinical trials of medicinal products, medical devices, and in vitro diagnostics.

After an initial phase analysing the root causes of challenges that sponsors of combined studies encounter, the COMBINE initiative is switching gear. The next phase has started and will identify possible solutions so that Europe can remain an attractive place to perform combined studies.

The second phase of the project, as agreed in December 2024, will involve the development and implementation of the above-mentioned solutions. Key cross-sectorial projects are starting, and the collaborative effort will involve Member States’ competent authorities, the European Commission, medical research ethics committees, and stakeholders from both the medicinal product and medical device sectors.

With its centralised procedure, EMA oversees the authorisation of medicines used in combination with medical devices including companion diagnostics. As such, the Agency is actively involved in the COMBINE programme ultimately supporting the availability of innovative treatments for EU patients.

Morgane De Verdiere, European Medicines Agency, NL

My name is Morgane De Verdiere and I am the head of the Medical and Health Information service better known within the European Medicines Agency as the Medical Writers team. 

I trained as a pharmacist in Paris and moved to the UK in early 2000 to work in Regulatory Affairs for a pharmaceutical company. I joined EMA in early 2006, working in the 

Committee for Medicinal Products for Human Use (CHMP) secretariat for several years. After a stint in our Access to Document service, I moved to my current role in 2019 where amongst other things I oversee all medicines-related content that we publish in lay language.

 At EMA, writing is a big part of our work and communicating clearly is a strength we cultivate and share internally. I am a strong believer that anyone can get better at writing clearly.

 

The Role of Notified Bodies in Combination Products

The Role of Notified Bodies in Combination Products

Medical device Notified Bodies (NBs) work with many types of combination products. This session aims to discuss the combination products in scope of notified bodies and their regulatory requirements. This will cover Integral drug device combinations, regulated as medicines but assessed by NBs under Article 117, device drug combinations that fall under Rule 14 as well as discuss integration of digital features into these combinations.

Dr Jonathan Sutch, BSI Group, UK

Dr Jonathan Sutch is a principal medicinal specialist at the Notified Body BSI Group, working with medical devices containing medicinal substances and drug/device combinations. Jon trained as a Pharmacist at the London School of Pharmacy prior to completing a PhD in Pharmaceutical Sciences at Nottingham University. He has 15 years of experience in the pharmaceutical industry as a formulation scientist and manager before moving to BSI 7 years ago.

Medical Devices and In-Vitro Diagnostics Used in Drug Clinical Trials: Principles of Use and Sponsor Responsibilities Under the Medical Device and IVD Regulations Requirements

Medical Devices and In-Vitro Diagnostics Used in Drug Clinical Trials: Principles of Use and Sponsor Responsibilities Under the Medical Device and IVD Regulations Requirements

Introduction
– Definition of combinations products
– Type of devices used in drug clinical trials
– Regulatory pathway

Clinical Trials with a CE-Marked device as delivery system
– Clinical development of the DDC
– Sponsor responsibilities

Combined Studies
– Definition
– Interface between Regulation (EU) 536/2014 on clinical trials for medicinal products for human use (CTR) and medical device regulations (EU) MDR/IVDR
– Update on combined projects.

Takeaways

Dr. Fatima Bennai-Sanfourche, Bayer AG/Medtech & Pharma Platform, Germany

Dr. Fatima Bennai-Sanfourche currently serves as the Global Senior Director of QA&RA Compliance for Medical Devices, Combination Products, and eHealth at Bayer AG. In this role, she ensures regulatory compliance and high product quality across Bayer’s medical device and eHealth portfolio. She also oversees the compliant use of medical devices and software tools in clinical investigations and trials, adhering to Good Clinical Practice.

She has a rich background in the medical field, with over 20 years of experience in quality management, regulatory affairs, and the development of medical devices, including software, in vitro diagnostics, and combination products. Her career at Bayer began in the medical affairs and pharmacovigilance department, where she served as the Director of Medical Device Safety and Global Pharmacovigilance/Medical Device Safety Officer.

Her academic journey started with a focus on Biology, specialising in Biochemistry, Immunology, and Pharmacology. She earned her PhD in Pharmacology and Pharmacochemistry from Strasbourg, France. Dr. Fatima-Bennai-Sanfourche early professional life was dedicated to research and development in France, Sweden, and Germany, focusing on cerebrovascular diseases, hypertension regulation, and immunoassay development.

In addition to her current responsibilities, Dr. Fatima-Bennai-Sanfourche leads the implementation of the Medical Device Regulation (MDR) for PH-Bayer AG. She has been recognised for her expertise and contributions to the field, being nominated by the European Commission in 2019 as an EFPIA observer for the Post-Market Surveillance and Vigilance (PMSV) subgroup (GROW.D4). Since July 2021, she has been a member of the European Commission Post-Market Surveillance (PMS) task force, contributing to the preparation of MDR PMS guidance according to Article 83.

Dr. Fatima Bennai-Sanfourche is actively involved in several professional groups and initiatives, including:

  • Member of the Regulatory group of the EFPIA for medical devices.
  • Member of the EU Commission group for Clinical Investigation and Evaluation of medical devices (MDCG CIE).
  • Chair of the In vitro Diagnostic group at Medtech and Pharma Platform (MPP).
  • Member of the European Acceleration Clinical Trials (ACT EU) initiative chaired by the EMA.
  • Member of the ACT EU Multi-stakeholder Platform Advisory ad-hoc Group.
  • Member of the RWD used in pragmatic trial group at TransCelerate.

Her extensive experience and leadership in the pharmaceutical, medical device, and regulatory fields make her a pivotal figure in the Medtech and pharma regulatory landscape in Europe.

Coming Up Next

Coming Up Next

Jules Kovacevic, Ambermed, Serbia
PATIENT & END USER PERSPECTIVE: Beyond the Device: Trust, Challenges and the Human Experience in Combination Products

PATIENT & END USER PERSPECTIVE: Beyond the Device: Trust, Challenges and the Human Experience in Combination Products

As a person living with type 1 diabetes, I rely on combination products—an insulin pump and a continuous glucose monitor (CGM)—to manage my condition every day. These technologies have transformed diabetes care, offering better glucose control, fewer complications, and an improved quality of life. But they are not just devices; they are part of my daily decisions, emotions, and experiences.
In this talk, I will explore what it means to trust a medical device. Trust is not built overnight—it is earned through reliability, accuracy, and usability. What happens when technology evolves faster than patient confidence? How do we navigate the challenges of updates, recalls, or system failures?

Beyond the technical aspects, I will highlight the essential truth: a patient is more than a device. While combination products are powerful tools, they must be designed with the user—the human—at the centre. Patients are not just data points; we have fears, preferences, and unique needs that should shape product development and communication.
By bringing together drugs, devices, diagnostics, and digital health, we have an opportunity to improve lives. But to truly help patients, we must be recognised as partners, not just users.

Daniel Newman, Patient Advocate, UK
Daniel is a multi-award-winning diabetes advocate, podcast host, producer, and patient author who has been living with Type 1 diabetes since 1996. He is the host of the award-winning Talking Type 1 podcast, where people living with different types of diabetes share their personal journeys of life with diabetes.
Daniel served as a patient representative on the committee that recently updated the National Institute for Health and Care Excellence (NICE) guidelines regarding access to glucose sensor diabetes technology. Having seen first hand how diabetes technology has evolved over the years, he now uses it to manage his condition and understands its impact on daily life.
He has worked with NHS England, Diabetes Africa, Roche, and Boehringer Ingelheim to advocate for better diabetes care and ensure the patient experience remains central to decision-making. He is passionate about access to diabetes technology and equity in healthcare.
Daniel was part of The Diabetes Football Community, which won the Unsung Hero QiC award in 2022 and he personally won the People’s QiC Award in 2024 for his contributions to the diabetes community.
SAFETY REPORTING PERSPECTIVE: Transforming DDC Safety Reporting with Automation and Generative AI

SAFETY REPORTING PERSPECTIVE: Transforming DDC Safety Reporting with Automation and Generative AI

The evolving regulatory landscape for Drug-Device Combination (DDC) products requires manufacturers to meet stringent safety reporting obligations under FDA (MedWatch, 21 CFR Part 4) in the USA and EU Medical Device Regulation (MDR; Regulation 2017/745, Article 117, and Notified Body Opinion [NBOp] requirements). Ensuring compliance while managing increasing data volumes and regulatory scrutiny demands innovative solutions—Automation and Generative AI (GenAI) offer a transformative approach.
This presentation will explore how AI-driven automation enhances adverse event detection, leveraging Natural Language Processing to extract safety signals from clinical trials, electronic health records, and real-world data sources. Predictive analytics enables proactive identification of trends in device malfunctions and drug interactions, reducing regulatory risks.
A key focus will be on Article 117, which mandates an NBOp for integral DDCs before EU market approval, significantly impacting compliance timelines. We will discuss how AI-powered automation streamlines Notified Body submissions, ensuring seamless integration with EUDAMED and accelerating incident reporting. Additionally, AI-driven chatbots can assist healthcare professionals in real-time reporting, improving data accuracy and integrity.
Attendees will gain actionable insights into AI/machine-learning-driven pharmacovigilance, learning how automation can reduce costs, optimise compliance workflows, and enhance patient safety, making it an essential tool for future-proofing DDC regulatory strategies.

Ajit Sankar, Accenture, Switzerland
Dr. Ajit Sankar Mallik leads the EU MedTech Clinical Practice at Accenture. With 15+ years of global clinical, regulatory, and quality affairs experience, he specialises in Medical Devices, Drug-Device Combinations (DDC), and In Vitro Diagnostics (IVDs), with a strong focus on Software as a Medical Device (SaMD) and Digital Health products.
His expertise spans clinical evidence generation, regulatory strategy development, and product lifecycle management, ensuring compliance with FDA, EMA, Health Canada, Swissmedic, and EU Notified Bodies. He has played a key role in achieving Notified Body Opinions (NBOp) under Article 117 of MDR for various DDCs, including insulin and GLP-1 therapies.
Dr. Mallik holds an MDPhD from the University of Zurich, a Master’s degree in Medical Science & Technology from IIT Kharagpur, and was a visiting scientist at Harvard Medical School. His regulatory leadership has contributed to breakthrough device designations, per-market approvals, and Medical Device Regulation (MDR) compliance across global markets. His work integrates AI-driven automation and regulatory intelligence, optimising safety reporting and market entry strategies for DDC products.
Advocating for Patient Involvement Throughout the Medical Device Life Cycle: The Role of Medical Writers and Communicators

Advocating for Patient Involvement Throughout the Medical Device Life Cycle: The Role of Medical Writers and Communicators

As the MedTech industry continues to evolve, the importance of integrating patient perspectives throughout the medical device life cycle, including drug-device combinations, diagnostics and digital products, is becoming increasingly evident. In this talk, we will explore critical stages where patient involvement can provide substantial value — ranging from concept development and design to education and training. By drawing parallels to the pharmaceutical sector, where patient-centric practices are better established, we will examine gaps and barriers within MedTech that hinder patient integration. Understanding these challenges is essential for professionals in the field to devise effective strategies for change. Medical writers and communicators are ideally poised to advocate for this shift. By emphasising clear, patient-focused information and fostering transparent communication channels, we can champion the inclusion of patient voices, ultimately enhancing the utility and acceptance of medical devices. This talk will provide actionable insights for leveraging medical writing to align the MedTech industry with patient-centric values, ensuring that patient needs and experiences are prioritised.

Joseph Smith, Costello Medical, UK

Joseph is a Consultant at Costello Medical, one of the most established independent agencies delivering medical communications and Health Economics and Outcomes Research (HEOR) services. Joseph works within Costello Medical’s specialist MedTech team, with a focus on medical communications. He has extensive experience working with both pharmaceutical and MedTech companies, spanning publications, medical affairs, and marketing communications. Prior to joining Costello Medical, Joseph completed a PhD in molecular oncology at the Northern Institute for Cancer Research, Newcastle University.

Morning Recap; Introducing the Afternoon Session

Morning Recap; Introducing the Afternoon Session

Cherry Malonzo Marty, Sitem, Switzerland
Cherry Malonzo Marty is a Medical Doctor and Biomedical Engineer by training. She has more than 12 years of experience working in various functions in education, clinical settings, research, and regulatory affairs.
Since 2018, she has been working as a contract regulatory writer and consultant for medical device, combination product, in vitro diagnostics (IVD), and Software as a Medical Device (SaMD) submissions in the US and EU, handling Class I to Class III devices across a range of medical applications. Since 2021, Cherry is the module leader for International Regulatory Affairs at the Sitem Center for Translational Medicine and Biomedical Entrepreneurship in Bern, Switzerland. She has co-authored the book chapter “Evolving Global Regulatory Landscape” in the 1st edition of The Combination Products Handbook published in 2023.
Cherry co-leads the EMWA workshop Introduction to Combination Products in the US and the EU.
Navigating the Challenges of Combined Product Development: The Essential Role of Medical Writers

Navigating the Challenges of Combined Product Development: The Essential Role of Medical Writers

The surge in the development of combined products, which integrate medicinal products, medical devices, and digital health technologies, presents significant challenges for pharmaceutical companies. The lack of a harmonised regulatory framework across different jurisdictions complicates the efforts, while the awareness of medical device requirements often falls short among development teams. These complexities necessitate innovative collaboration models and adapted ways of working. This session will explore the multifaceted challenges of developing combined products and propose strategies to effectively bridge the gap between pharmaceuticals and medical devices. Medical writers are crucial to this process, offering a unique skill set essential for facilitating this integration. This session will discuss the evolving role of medical writers and the new competencies they need to embrace to contribute effectively to the development of such products.

Kathy Wang, AstraZeneca AB, Sweden

Kathy Wang is a seasoned regulatory affairs professional with a robust track record in the medical device and drug-device combination product sectors. As the Regulatory Affairs Director for Devices and Digital Therapeutics at AstraZeneca, she plays a pivotal role in supporting the development and marketing of combined drug-device products. Kathy offers strategic regulatory guidance throughout the product lifecycle, from pre-clinical phases to market launch. Her international experience, gained from living and working in China, Australia, and Sweden, has fuelled her strong interest and expertise in global regulatory affairs.

Medical Writing for Medical Devices with Ancillary Drugs

Medical Writing for Medical Devices with Ancillary Drugs

Medical device–medicinal product combinations, where the primary mode of action is attributed to the device, are regulated under medical device regulations. This presentation offers a comprehensive overview of the relevant regulatory landscape, with a particular focus on Europe. It also provides practical tips and valuable insights for crafting effective documentation for medical devices incorporating ancillary medicinal products.

Beatrix Doerr, Independent, Germany

Trained in veterinary medicine with a thesis in parasitology, Beatrix began her career as a veterinary surgeon before transitioning into clinical research, where she progressively assumed senior leadership roles. She led the European Transcatheter Heart Valve Program, with responsibility for pre- and post-market clinical studies, department coordination, implant specialists, and safety. Since 2011, Beatrix has been working independently through her company, Coriuvar, which specializes in cardiovascular medical devices, with a primary focus on regulatory writing, scientific publications, and safety reporting.

Cybersecurity in Healthcare Products

Cybersecurity in Healthcare Products

The rapid advancement of medical technology brings increasing cybersecurity challenges. As medical devices and drug-device combination products integrate with wireless networks and cloud systems, they become prime targets for cyberattacks. A single breach can endanger patient safety, disrupt healthcare operations, and expose sensitive medical data.
Regulatory bodies provide cybersecurity guidelines, but compliance alone does not ensure protection. Developers must embed security throughout the product lifecycle by conducting risk assessments, implementing encryption, enforcing access controls, and continuously monitoring vulnerabilities.
Addressing these evolving threats requires collaboration between companies, healthcare providers, and cybersecurity experts. As cyberattacks grow more sophisticated, the industry is adopting and constantly refining security frameworks to safeguard medical technology, the question remains: in a world of ever-evolving threats, can we ever be truly secure?

Dragan Jovic, Re5 ApS, Denmark

Dragan Jovic is a military telecommunication engineer with expertise in military telecommunications, cybersecurity, and operational planning who transitioned to the Medical Device field.

He is currently employed as the Director of Quality and IT at a Danish medical device manufacturer, while also working as a regulatory consultant. With 9+ years of regulatory experience, he specialises in CE Marking, Software as a Medical Device, Risk Management, and Post-Market Surveillance. He has worked on cybersecurity in medical devices, ensuring compliance with ISO/IEC 27001 and Medical Device Regulation (MDR) cybersecurity requirements.

As a lead auditor (ISO 13485, ISO/IEC 27001), MDSAP auditor, and technical documentation assessor, he supports certification processes. He has extensive experience in health informatics, AI-driven medical solutions, and telecom-based telehealth systems.

Dragan lectures at the Serbian Institute for Standardisation, speaks at EMWA conferences, and has worked globally, including direct client projects in Denmark. His expertise includes FDA pre-market submissions (510k), software development (IEC 62304), and cybersecurity risk management.

Diagnostics and Digital Connectivity

Diagnostics and Digital Connectivity

Rapid advancements in digital diagnostics are revolutionising healthcare, offering unprecedented speed and precision in patient diagnosis. Connected in vitro diagnostic (IVD) devices—integrating cutting-edge sensors, sophisticated software, and seamless cloud connectivity—are at the forefront of this transformation. Yet, as these devices evolve, they face a complex interplay of challenges. Navigating the stringent EU regulatory landscape (IVD Regulation [IVDR], Medical Device Regulation [MDR], and General Data Protection Regulation [GDPR]) while ensuring flawless hardware-software integration and robust cybersecurity creates a delicate balancing act between innovation and patient safety.
As digital diagnostics continue to reshape patient care, the pressing question remains: How do we fully leverage these innovations while ensuring that every breakthrough is secure, reliable, and patient-centric?

Ery Anguiano, Apsis LLC, USA

Ery Anguiano has 15 years of medical device experience across a wide array of product types and manufacturers. He earned degrees in Chemical Engineering and Biotechnology from the University of Utah, and worked and consulted on Quality Engineering, Supplier Quality Engineering and Quality and Regulatory Affairs projects for Fortune 500 medical device companies as well as small enterprises. His expertise includes digital products and connected combination devices, such as software-based in vitro diagnostics (IVDs) and smart injectable systems. He has successfully navigated the evolving regulatory landscape for these integrated solutions, ensuring they meet stringent compliance standards. Ery has a deep understanding of US and international quality and regulatory standards, and enjoys guiding small teams to market clearance.

Introduction to IVDs: Diagnostics and CDx

Introduction to IVDs: Diagnostics and CDx

Anne Paulussen, Flen Health, Belgium
Anne Paulussen is a seasoned regulatory affairs expert with over a decade of experience spanning in vitro diagnostics (IVDs), combination products, and biotechnology. She specializes in strategic regulatory guidance for combined submissions of investigational drugs with investigational devices, with a strong focus on Companion Diagnostics (CDx) under the EU In Vitro Diagnostic Regulation (IVDR).
Anne has successfully guided start-ups bringing their IVDs to the EU market, and advised major pharmaceutical and diagnostic companies on Annex XIV IVDR applications. Her expertise extends to global regulatory strategy, FDA engagement, and clinical trial compliance and she is also an experienced speaker and trainer at industry conferences such as EMWA, RAPS and Healixia Clinical Trial conference.
Currently, Anne serves as Quality, Regulatory, and Clinical Affairs Director at Flen Health, overseeing a team navigating global regulatory challenges. As co-chair of RAPS Belgium LNG and a member of EMWA’s Medical Device SIG, she actively contributes to the regulatory community.
With a passion for knowledge-sharing and regulatory excellence, Anne is dedicated to helping companies bring innovative combination products and diagnostics to market while ensuring compliance with evolving regulations.
Medical Writers’ Guide to Companion Diagnostics Under IVDR and Combined Studies in the EU

Medical Writers’ Guide to Companion Diagnostics Under IVDR and Combined Studies in the EU

Companion diagnostics (CDx) play a crucial role in precision medicine by identifying patients most likely to benefit from specific therapies. Under the EU In Vitro Diagnostic Regulation (IVDR), CDx are classified as class C devices, and conformity assessment for market approval requires interaction with both Notified Body (NB) and EMA for medicinal products. This presentation provides medical writers with an introduction to CDx under IVDR.
Prior to seeking market approval, the CDx must be evaluated for its performance, typically in a clinical trial. Conducting combined studies, that assess both an investigational medicinal product (IMP) and a CDx in a single trial, has proven to be a major challenge in the EU. While the Clinical Trials Regulation (CTR) governs IMPs, CDx fall under IVDR, requiring separate but interdependent regulatory approvals. Medical writers play a vital role in aligning documentation for competent authorities, ethics committees, ensuring consistency and compliance. This session will simplify the often-complex regulatory requirements and help medical writers to contribute effectively in getting approvals for the use of CDx in combined studies, supporting precision medicine and patient access to innovative therapies.

Pieter Bogaert, QbD Group, Belgium

Pieter holds a PhD in Biotechnology with an academic career as molecular immunologist and a technical expertise in flow cytometry. He became an in vitro diagnostics (IVD) consultant after holding several positions at an IVD manufacturer and a central laboratory contract research organisation (CRO) for clinical trials. At QbD Group, Pieter is currently a senior regulatory affairs consultant, specialised in IVD regulation, and ISO 13485 lead auditor. He supports IVD manufacturers from start-up companies to multinationals, as well as laboratories, in complying with Quality Management Systems (QMS) and IVD Regulation (IVDR) requirements. Pieter is also in the leadership team of the Belgian RAPS Local Networking Group.

Companion Diagnostics & Why We Need Them

Companion Diagnostics & Why We Need Them

Personalised Medicine and Individualised Therapies have rapidly evolved in recent years, with a focus on bringing forth the “right medication for the right patient”. Although these treatment options offer a tailored medicine that can tremendously benefit the patient, the ability to bring them to market requires a multi-faceted approach which requires the consideration of many key elements to ensure their success. Companion Diagnostics (CDx) are one element that is a key factor contributing to the success of the development and commercialisation of the medicinal product. Organisations have to consider the development of not only the medicinal product, but also the co-development of a CDx in parallel. This co-development strategy for a medicinal product and the CDx has proven challenging for even the most experienced of organisations. There are also the challenges that organisations are facing, with the rapidly evolving global regulatory landscape, which must be considered when co-developing the medicinal product and the CDx. Giving the proper consideration to both the medicinal product as well as the CDx, will position many organisations for success in the precision medicine and individualised therpeutic space.

Robert Saiz, BioNTech, US

Robert Saiz has been in the Biotechnology Industry for over 30 years. He started as a bench scientist developing in vitro diagnostic (IVD) assays for disease gene hunting, microsatellite and single nucleotide polymorphism (SNP) genotyping. From a bench scientist, he transitioned into product development of IVDs in the regulated space. Robert eventually transitioned from product development into Global Regulatory Affairs where he has focused his efforts for the last 15 years. Robert has worked for various small, mid-size, and global organisations, and has also worked as a consultant. Throughout his career, Robert has worked on a variety of medical devices and specialised in IVDs and medical devices for infectious diseases, hospital acquired infections, women’s health, drug screening, and companion diagnostics in oncology and rare diseases. Robert has a Bachelors degree in Biology from San Diego State University as well as a Masters Degree in Clinical Research from the University of California at San Diego.

8:45 am to 12:30 pm

DDA34 Briefing Documents – The communication channel to Health Authorities from a Medical Writer’s perspective

Medical Writers play a key role in aligning the cross-functional input during briefing documents development. Attendees will acquire knowledge of the goals, interaction types and structure of Briefing Documents directed to the EMA and FDA, as well as strategical consideration to effectively lead and coordinate this multidisciplinary effort.
Participant profile: Regulatory Medical Writers involved in Briefing Document development or interested in this highly strategical document that shapes a product’s clinical development program. Experience in clinical study protocol writing or previous attendance of the EMWA workshop ’Basic Concepts of Study Design in Clinical Development’ (DDF13), is recommended
Sabrina Stöhr

Sabrina is a Regulatory Medical Writer with 10+ years of experience in clinical development. She has been involved in document writing across all stages of development and in various indications (e.g. oncology, inflammatory diseases, biosimilars). She has experience in the development of Briefing Documents directed to the EMA and FDA as well as other regulatory interaction and meetings. Following a PhD in human genetics and a postdoc in cancer research, she pursued an advanced training in clinical research before joining the pharmaceutical industry. Sabrina is also an experienced EMWA workshop leader.

Katrin Zaragoza-Doerr

A firm advocate of the strategic importance of Medical Writers, Katrin has been overseeing and supporting the development of regulatory documents during clinical development for the past 10 years. She has written Briefing Documents directed to the EMA, FDA and CDE in multiple indications. Having worked as an employee and as a freelancer, she has founded her own consultancy offering medical writing services, mentoring and training. With a PhD and 10 years as a molecular medicine scientist, she joined the pharmaceutical industry in 2011. Her experience in clinical operations further complements her overview of clinical research and associated documents. Katrin is an EMWA member since 2018 and an EMWA ambassador in and around Barcelona.

DDA35 Safety and Contraception Information for the Informed Consent

The purpose of the Informed Consent Form (ICF) is to provide potential study participants with a clear summary of the risks involved in the study. This information should be written in easy-to-understand language so that participants can make an informed decision whether to participate in a clinical trial. It is essential for project and trial teams in clinical research to regularly update this information. Medical writers with expertise in regulatory and lay language writing can contribute valuable skills in developing and updating the risk information.
Participant profile: This workshop is ideal for medical writers with experience in creating documents for regulatory or non-specialist readers. It is especially beneficial for medical writers involved in developing informed consent materials for potential study participants. Medical writers who may need to produce written information in lay language about the safety and contraceptive aspects of a drug in clinical research will find this workshop particularly useful. Ideally participants understand an investigator brochure and a clinical trial protocol.
Cornelia Weiss-Haljiti PhD, Boehringer Ingelheim, Germany

Cornelia Weiss-Haljiti is an Expert Medical Writer and a biochemist by training with a PhD in endothelial cell biology. For 10 years, she worked as a scientist leading projects and laboratories in academia, biotech, and pharmaceutical industry. Cornelia developed expertise in the discovery and validation of targets, drugs, and biomarkers.

In 2012, Cornelia joined Boehringer Ingelheim Pharma GmbH & Co. KG. to become a Medical Writer. She wrote regulatory documents across all phases and therapeutic areas. She holds the EMWA foundation and advanced certificate. Over time she became particularly interested in plain language writing, graphics, and design. She was the design lead of a digital platform to share lay summaries of study results with the public. Currently she leads and represents Informed Consent activities by the Lay Language & New Media Team, a specialised medical writing team within Boehringer Ingelheim.

 

NEW MSF16 Psychology Essentials for medical writers

The workshop will introduce key psychological concepts and will outline the main research methods and procedures used to observe, describe, predict, and explain behaviours and mental processes.
The aim is to educate participants on conventions of writing in psychology. The content will cover the purpose and types of psychology documents, sources used in writing psychology, differences between qualitative and quantitative studies, the use of the American Psychological Association (APA) format, psychology terms, ethics, main tests and measurement used to perform research objectives in various fields. There will be particular emphasis on practical aspects throughout questions and exercises.
This workshop is aimed at medical writers with little or no experience of writing documents in psychological sciences and who would like to learn more about the study of human behaviours, attitudes, perceptions and emotions. As a foundation workshop, there are no prerequisites to attend.
Alessia Spina

Alessia is a medical writer and a senior scientific assistant with 10 years’ experience at IRCCS Policlinico San Donato, a research hospital specialized in cardiovascular treatments. She has worked as biomedical librarian and scientific event manager, with a prominent aptitude for medical communications, research manuscripts and grant writing. She has a B.S. degree in interpreting and translation, and experience in psychological sciences and techniques with a commitment to therapeutic photography and creative writing. She is exploring the efficacy of psycho-cardiology therapy in patients with rare and congenital heart diseases throughout the direction of two research projects employing art-therapy exercises and environmental psychology experiments.

NEW PTF45 Working with Key Opinion Leaders (KOLs) in Medicine

Objective:

By the end of this workshop participants will be aware of the main types of KOLs in medicine, the advantages and disadvantages of working with them, as well as learning relevant strategies to interact with KOLs.

Content:

Pre-workshop assignment

1 hour.

Post-workshop assignment

2 hours.

Participant profile: This standalone workshop is designed for all medical writers who have dealings with Key Opinion Leaders (KOLs) as part of their job. KOLs are an integral element of medical publications and presentations yet there is little information on who they are and how they should be managed. This workshop examines the different types of KOLs in medicine, the considerations behind using KOLs as well as strategies to interact with them. As an interactive workshop, participants are requested to share their own experiences with KOLs during the workshop. Please also bring your computer to the workshop.

Diarmuid De Faoite, MBS, BBS, BA

Diarmuid is an EMWA workshop leader and served as a member of the EMWA Executive Committee from 2012 to 2022. Originally an academic researcher on the subject of entrepreneurship, he has worked as a business lecturer and researcher, editor and writer in Ireland, Germany and Switzerland. After 15 years in orthopaedic clinical research, his most recent role was as the Key Expert Manager for a dental intraoral scanner company. Diarmuid is also a general freelance writer and is currently completing a PhD in Public Health with a focus on Patient-Reported Outcome Measures (PROMs) in Low to Middle Income Countries.

12:30 pm - 1:15 pm

The CORE Reference Project Learn and Share

Do you write or review clinical documents for public disclosure, including clinical study reports? Are you part of the growing discipline of transparency and disclosure (T&D) in respect of regulatory documents? If so, watch this short reminder of how this EMWA Special Project supports self-led continuing professional development for regulatory medical writers and T&D professionals.
Then, book your slot to join us at The CORE Reference Team’s free ‘Learn and Share’ face-to-face session on Thursday 8 May 2025, 12.30-13.15 pm (CET). We will update you about our new LinkedIn page; plans for our new website; and our next Webinar (June 2025).
 
We also want to learn from you about how else we can support your learning – so bring your lunch along and join the conversation.
Sam Hamilton

Sam Hamilton is a postdoctoral virologist, with 32 years in clinical and regulatory medical writing and leadership roles in the pharmaceutical industry. Sam has a special interest in public disclosure of clinical-regulatory documents as Chair of the EMWA-AMWA group who delivered the open-access www.core-reference.org in May 2016. Sam is long-time supporter of EMWA serving in various roles over 19 years, notably as Freelance Advocate; Editorial Board member for Medical Writing (MEW); Workshop Leader; Expert Seminar Series (ESS) Chair; and Vice President and President. Sam was elected an EMWA Nick Thompson Fellow in 2018 for her services to the Association. Sam is currently MEW Section Editor for the “Regulatory Public Disclosure” Section, and Chair of The CORE Reference Project.

Vivien Fagan

Vivien has 30 years of experience in an international pharmaceutical CRO. In her current position as Director, Global Medical Writing and Head of IQVIA’s Clinical Trial Disclosure group, Vivien manages a team of UK and European Medical Writers along with a group of Clinical Trial Disclosure Specialists based out of India. Vivien was a member of the EMWA-AMWA group who delivered the CORE Reference project (www.core-reference.org; an open access resource to support authoring of disclosure-ready CSRs).
Vivien is an EMWA Workshop Leader, DIA panellist and a member of The CORE Reference Project committee. In more recent years, Vivien has been an Expert Seminar Series (ESS) presenter on the topic of the EU CTR/CTIS.

Alison McIntosh

Alison has been a medical writer for the pharmaceutical industry for almost 30 years, and has written extensively for regulatory authorities, and other audiences. She became a medical writer after completing her PhD and a further 5 years of postdoctoral research in molecular virology. Her wealth of experience encompasses many different types of documents including manuscripts, book chapters, and clinical and scientific abstracts, as well as clinical study reports, investigator brochures and other regulatory documents. Alison has been a workshop leader since 2001 and is a section editor for the EMWA journal Medical Writing. She currently serves as a committee member of the EMWA CORE Reference Project.

Zuo Yen Lee

Zuo Yen Lee is an experienced medical writer with 8 years of regulatory medical writing experience and 10 years of combined experience in scientific and diagnostic research. She provides expertise in writing clinical and regulatory documents in compliance with the global/regional/local guidelines for a broad range of therapeutic areas and indications. In her current role, Zuo Yen leads several drug/vaccine assets and provides the medical writing strategy for the development of clinical programs and content of documents. She is a section co-editor of the EMWA MEW journal, regularly writes for MEW, and a committee member of CORE Reference Project, with a special interest in regulatory public disclosure.

12:30 pm - 1:15 pm

Discovering The Crucial Importance of Closed-Loop Gen-AI for Regulatory Writing Success

As Gen-AI capabilities and companies continue to grow, there can be a rush to apply tools that might not be the best-in-class. We’ll discuss and navigate the issue of Closed-Loop vs. Open-Access AI and what it means for your IP, security, and AI-model integrity.  Gain an understanding of the different forms of AI being applied and the best combinations to truly accelerate your regulatory writing.

David Piester
Chief Commercial Officer, Zyliq, Inc

1:30 pm to 5:00 pm

DDA1b Writing Submission Dossiers using the Common Technical Document

To introduce participants to the preparation of clinical submission dossiers according to the CTD
To convey general principles and process of summary writing
To facilitate understanding of the limits of the available regulatory guidance
Participant profile: The course is intended for medical writers with little or no experience of writing clinical submission dossiers although participants should be familiar with the clinical development process and have had some experience of writing clinical study reports.
Claire Dyer

Claire is a Senior Director of Global Submissions at Certara. She worked in pharmaceutical and academic research before and after her PhD in immunology and oncology. Claire has worked within the pharmaceutical and CRO industry in a number of clinical and medical roles including medical information and sales/marketing. After leaving the big smoke in London, she decided on a career in medical writing. Claire has been a medical writer since 2007 and worked as a MW Manager at Trilogy and ICON before joining Certara as one of the Submission Leads. She has a wide range of experience and a particular interest in regulatory documents covering various therapeutic areas.

DDF36b – An Introduction to Clinical Trial Disclosure– the Regulatory Requirements, Industry Commitments, and Protection of Data Privacy and Company Confidential Information

Attending this workshop will help participants to understand the regulatory requirements (e.g., EMA Policies 043 and 070, the EU Clinical Trials Regulation [EU CTR], and national Freedom of Information laws) and industry commitments for clinical trial disclosure, understand how patients and investigational sites may benefit from this disclosure, be introduced to the new documents required due to the disclosure (EMA Policy 070 anonymization report, protocol lay synopsis, lay summaries, etc.), be aware of the challenges created by clinical trial disclosure for when drafting clinical documents (e.g., protocols, clinical study reports), understand what is company confidential information, personal protected information, and data privacy, and understand how data privacy and confidential information is protected (e.g., using anonymization or redaction).
Attending this basic workshop before attending one of the specialist workshops will enable participants to gain the most benefit from the advanced workshops.
Participant profile: This basic workshop is intended for participants directly or indirectly involved in the planning, analysis and/or reporting of clinical trials, or in the design of clinical development programs, or those with little or no background in this area who are interested in learning the basics. Previous experience or background knowledge of clinical trial disclosure is not required. This workshop will benefit newcomers to the topic, but also those simply wishing to update their knowledge of this topic.
Christopher Marshallsay

Christopher Marshallsay is Head of Scientific/Medical Writing & Trial Transparency at BioNTech SE (Mainz, Germany). Christopher is a PhD biochemist with over 25 years of experience in various roles in clinical development – including pharmacokinetics, medical writing, clinical trial disclosure, and as department/function head – whilst located in Aachen, Frankfurt, Mainz, and Paris. He has previously worked at Ciba-Geigy, Aventis, Sanofi, and Grünenthal. He currently manages a group of teams providing integrated scientific, regulatory, and publication writing services for research, non-clinical, and clinical teams. His team also provides trial transparency services (clinical study registration/results posting, Policy 0043/70 requests, freedom of information requests, voluntary disclosure requests, and protection of company confidential information and personal protected information), and publication management and submission services. As a process nerd, Christopher is a key driver for process optimisation and standardisation at BioNTech. Christopher is also an experienced lecturer and workshop leader. He is a Committee Member of the Regulatory Public Disclosure Special Interest Group.

MCA7 Writing lay language summaries of study results according to EU Regulation

Writing lay summaries is a difficult and challenging task. Medical writers with an interest in lay writing are well suited for this new and upcoming activity. However, the provision of lay summaries requires a lot more than good lay language writing. The workshop will introduce the many different aspects of providing lay summaries: the available regulatory guidance, the positions of various stake holders (pharma and patient organisations), the intricacies of the actual writing of lay summaries, and considerations for appropriate distribution of the lay summaries.
Participant profile: This workshop is for medical writers who want to engage in the writing of lay summaries of study results as mandated by the EU regulation. Participants should already have an understanding of CSR structure (ICH E3) and should know the basics of clinical research (trial design, efficacy and safety analysis, basic statistics).
Thomas Schindler
Thomas M Schindler studied biology and linguistics in Germany and the UK, obtained a PhD in molecular physiology, and did postdoctoral research in the UK. Thereafter, he became an editor of popular science books in biology, geography, and astronomy. He then turned to medical writing and has now gained some 25 years of experience in both medical affairs and regulatory medical writing including the preparation of all documents for marketing authorization applications around the globe. He founded and established the medical writing function at Boehringer Ingelheim and has recently headed the Innovation Medical Writing Group focussing on lay communication, good graphics development, video creation and AI-driven writing. He is currently Director Global Regulatory Affairs – Operations at BioNTech.
He was a member of the TransCelerate Return of Results work stream, is contributing to the Good Lay Summary Practice initiative and the PFMD Plain Language Summary guidance.
Julia Hild

Julia A Hild is a Senior Medical Writer at Boehringer Ingelheim with a background in pharmaceutical biology and biological sciences. She holds a doctoral degree in human biology and a degree in plain language writing. Since joining Boehringer Ingelheim in 2020, Julia has played a pivotal role in developing lay language documents across multiple therapeutic areas. She specializes in creating patient-friendly materials, including lay summaries, lay protocol synopses, and informed consent forms. Julia also works with visual media, creating scripts and storyboards for videos and comics to support patient understanding. She established processes in close collaboration with the Patient Engagement team to involve patients in the review of lay language documents, ensuring their feedback drives clarity, relevance, and truly patient-centric communication.

MCF31 A Structured Approach to Developing Medical Writing Content

Many medical writers, especially people new to the field, have difficulty coming up with a clear focus for their projects and developing them into a coherent document that accomplishes its objectives. This workshop provides a structured approach to conceptualizing and progressively building the content of any document.
Participant profile: This workshop is intended for medical writers of all levels and specialties. Prior experience as a medical writer is not required. The concepts covered in this workshop can be helpful to even the most experienced medical writers.
Stephen Gilliver

Stephen (Steve) Gilliver has been an EMWA member for 15 years and is a former Co-Editor of the EMWA journal, Medical Writing. He has spent the past 16 years working as an editor and medical writer. Having moved from the UK to Sweden in 2010, he ultimately settled in Malmö, where he now works home-based as a Manager, Medical Writing, specializing in publications (manuscripts, abstracts, posters). He is a joint British-Swedish citizen and speaks fluent Swedish.

Phil Leventhal

Phillip Leventhal, PhD is a Senior Manager, Medical Writing at the PPD clinical research business of Thermo Fisher Scientific, where he leads the Publications and Scientific Communications Team. Phil has over 20 years of experience in scientific and medical writing and earlier experience in pharmaceutical research and drug discovery. He has written nearly 200 published peer-reviewed publication and edited hundreds more. As Editor-in-Chief of Medical Writing and Executive Committee member from 2011 to 2020 (now Editor Emeritus) and a long-standing workshop leader for EMWA, he was awarded the Nick Thompson Fellowship in 2021 for exceptional service.

5:15 pm - 7:00 pm

Freelance business forum

The freelance business forum (FBF) is a free networking event held at each EMWA conference and a favourite event for many attending the EMWA conference. It is open to all EMWA members and not just freelancers. The aim is to get freelancers and those thinking of stepping into the world of freelance to get together and discuss key topics that affect freelancers on a daily basis. After a presentation from an invited speaker, attendees separate off into roundtable discussions which they can meander around to get points from various topics being discussed, towards the end of the session we ask each table leader to summarise the discussions. The discussions range from questions like, how do I become a freelancer? Where do I find clients? How do I advertise my services? To more technical aspects on indemnity insurance and writing contracts for new clients. Freelancers tend to work alone and at home, so it’s a great way to meet, network, ask questions and connect with fellow freelancers who can act as your work colleagues.

Friday, 9th May, 2025

7:45 am - 8:30 am

English breakfast’ Round table session

In this session, we’ll explore the realms of hyphens, articles, and serial commas. Whether English is your first language or you’re navigating it as a foreign language, come share your thoughts, ask questions, and gain insights into the nuances of English grammar. Feel free to grab some breakfast and bring it with you!

Johanna Svanberg

Johanna Svanberg studied physical chemistry in the UK. After finishing her DPhil, she worked as a freelance science writer and editor before turning to regulatory medical writing in 2022. Johanna currently works for Optimapharm.

7:45 am - 8:30 am

Round Table Session: Social media, corporate communications and the medical writer

This round table session aims to initiate a discussion on the role of medical writers (MWs) in social media (SM) writing, serving as a starting point for more in-depth events to follow during upcoming conferences. Why is SM important for corporate communications? What role should MWs have on SM and why is SM important for MWs? What gap can MWs fill in the SM space? On what SM platforms should we engage as MWs? What are the ethics and guidelines we should consider as we engage on SM? Panellists include: Pauliina Rasi, Roshini Beenukumar, Angela Potts, Giovanna Gelmi

Jessica Norberg
Pooja Phogat

7:45 am - 8:30 am

Round Table Session: EU AI Act- Deciphering the act for medical devices and medical writers

The round table discussion will be around the EU AI Act and its implications on medical device manufacturers and technical documentation.

  1. AI specifically with respect to medical device and how the EU AI act is impacting it. We will cover risk-based approaches, increased complexity of technical documentation and regulatory submissions with a special mention of intersection with MDR (with focus on integrated documentation, lean writing and compliance and conformity assessments).
  2. AI related to functional aspect in medical writing– The discussion will also be around transparency and human oversight requirements when using an AI technology during medical writing. Some other areas that will be covered are: enhanced regulatory literacy required for medical writers (QMS, data governance and risk management) to ensure all communications are compliant and mention the technology’s safety profile. A brief mention of a requirement for medical writers to work with AI technical experts and be literate about the new developments and the integration with the existing working processes will also be discussed.
Sepanta Fazaeli

Sepanta Fazaeli is Head of AI Solutions for Life Sciences at TransPerfect, where he leads the design and delivery of AI-powered solutions for pharmaceutical, biotech, and medical device organizations. His work spans the full spectrum of life sciences AI, from regulated document authoring and regulatory intelligence to safety surveillance, compliance automation, and conversational AI for clinical and regulatory workflows.

Before joining TransPerfect, Sepanta served as Clinical Systems & Medical Data Lead at Stryker, where he led enterprise-wide AI and data transformation initiatives across the Trauma & Extremities division, bridging clinical, regulatory, and technical domains. He also represented Stryker on the MedTech Europe AI Act Task Force, contributing to cross-industry efforts to shape practical, risk-based implementation of the EU AI Act for medical devices.

With a background in bioengineering and clinical data science, Sepanta brings both domain depth and technical fluency to the challenge of AI adoption in regulated environments. His approach centers on aligning people, processes, and technology to help life sciences organizations move from isolated pilots to integrated, enterprise-scale intelligence.

Namrata Singh

MBA is a physician turned medical writer with a passion to communicate science and medicine to different audiences: Right content for the right audience and at the right platform. She is the founder of Turacoz Group which provides strategic solutions to biopharma companies, medical technology firms, healthcare professionals, and research institutes around medical writing, evidence generation, insights gathering and medical education.

She has been involved in mentoring and training medical writers including the recent technology advancements. She is an active member of societies like European Medical Writers Association (EMWA), American Medical Writers Association (AMWA) and International Society of Medical Publication Professionals (ISMPP). She is the chair of AI working group and Entrepreneurship Special Interest Group at EMWA. She participates as speaker, organizing member and has authored publications around medical writing. She is based in Utrecht, The Netherlands.

7:45 am - 8:30 am

Round Table Session: Writing manuscripts within a medical device company: From request to publication

In this roundtable session, a science writer with 13+ years of experience within a medical device company will discuss the daily processes in writing/editing manuscripts for submission to peer-reviewed journals. The focus will be on full research articles. Attention will be paid to managing requests, collaboration, the writing process, journal selection, submission, and everything after. As these processes seem to differ from those in Pharma or working for a Med Comms agency, this roundtable may provide an insight into what it is like to write within a medical device company.

Michael Todd

Team Leader, Medical Writing at MED-EL Medical Electronics (Innsbruck, Austria)

Michael Todd has been working on manuscripts for MED-EL since 2011 and has been a team leader since 2021. Prior to working in medical writing, he taught English as a foreign language in Poland, Czechia, and Slovakia. Unusually for a medical writer, he comes from the humanities rather than the sciences (B.A. in English Literature, McGill University, Montreal). Originally from Detroit, Michigan, he lived in 6 countries before settling in Austria in 2011. He has assisted in writing/editing over 100 peer-reviewed publications.

CwP (Communicating with the Public Special Interest Group)

Med Coms SIG

8:45 am - 10:15 am

Patient Input into Trial Design – what can protocol authors do to help? – EDG

Incorporating patient input into the trial design/protocol has been shown to not only lead to more successful trials (with fewer dropouts) but also completed more quickly and are more cost-effective than those lacking a patient-centric approach. Patient-centric designs can include patient advocacy groups, decentralization of trial activities, and reducing participant burden. For many Sponsors, the “who, what, when, where, and how” to engage patients remains an obstacle to adoption and one that is often left until it is too late to materially impact the trial design or protocol. In this Expert Discussion Group, we will discuss different ways that patient input can be included into trial design and how medical writers can support patient-centricity during the protocol development stage. Covered topics will include common methods for patient input, direct and indirect approaches to encourage patient input, and future perspectives that promote adoption.
Participant profile: Expert Discussion Groups (EDGs) are group discussions led by a moderator/moderators, and the moderators will pose 2-3 questions ahead of the discussion on one topic to lead the discussion or to bring the discussion back to topic. There will be a max of 10 attendees, and we ask the moderators to set experience levels to keep the discussion standards and the level high. These sessions will be 1.5 to 2 hours.
Jonathan Mackinnon

Jonathan is an Associate Medical Writing Services Director at Parexel and is their lead Protocol Subject Matter Expert. He supports clients with protocol development across many therapeutic areas and within Parexel participates in multiple protocol-related initiatives including patient input into trial design and diversity. Jonathan teaches postgraduate modules for Protocol Development and Trial Designs at the London School of Hygiene and Tropical Medicine, UK.

8:45 am to 12:30 pm

Organisers: Raquel Billiones, Anne Paulussen, Cherry Malonzo Marty, Jules Kovacevic MD-SIG, Regulatory-SIG

Updates from the Dynamic Landscape of Medical Devices, In Vitro Diagnostics and Combination Products.

The regulatory landscape of healthcare products is very dynamic and constantly changing. This ESS will provide the latest updates from the field of medical devices, in vitro diagnostics and combination products that are relevant to experienced medical writers and communicators working in this field.

Introduction

Introduction

Cherry Malonzo Marty, Sitem, Switzerland
Cherry Malonzo Marty is a Medical Doctor and Biomedical Engineer by training. She has more than 12 years of experience working in various functions in education, clinical settings, research, and regulatory affairs.
Since 2018, she has been working as a contract regulatory writer and consultant for medical device, combination product, in vitro diagnostics (IVD), and Software as a Medical Device (SaMD) submissions in the US and EU, handling Class I to Class III devices across a range of medical applications. Since 2021, Cherry is the module leader for International Regulatory Affairs at the Sitem Center for Translational Medicine and Biomedical Entrepreneurship in Bern, Switzerland. She has co-authored the book chapter “Evolving Global Regulatory Landscape” in the 1st edition of The Combination Products Handbook published in 2023.
Cherry co-leads the EMWA workshop Introduction to Combination Products in the US and the EU.
Notified Bodies’ experience with Combination Products

Notified Bodies’ experience with Combination Products

The introduction of the MDR has brough in some additional requirements and challenges for combination products. This session will discuss the progress and learnings with examples, focussing on Article 117 combination products requiring Notified Body Opinions and Rule 14 devices with ancillary medicinal products requiring Competent Authority consultations. The session will cover the process and documentation required for these regulatory routes, the common pain points as well as point to available guidance.

Dr Jonathan Sutch, BSI Group, UK

Dr Jonathan Sutch is a principal medicinal specialist at the Notified Body BSI Group, working with medical devices containing medicinal substances and drug/device combinations. Jon trained as a Pharmacist at the London School of Pharmacy prior to completing a PhD in Pharmaceutical Sciences at Nottingham University. He has 15 years of experience in the pharmaceutical industry as a formulation scientist and manager before moving to BSI 7 years ago.

Combined studies and COMBINE PROJECT

Combined studies and COMBINE PROJECT

  • Combined Studies
    • Definition
    • Interface between Regulation (EU) 536/2014 on clinical trials for medicinal products for human use (CTR) and medical device regulations MDR/IVDR
    • Update on combined projects.
Gabriella Di Matteo

Pfizer Global Regulatory Operations, Belgium

Gabriella (Gaby) Di Matteo is currently the Director and Team Lead in Pfizer Clinical Trial Regulatory Operations (CTRO), where she leads a team of Clinical Trial Submissions Managers responsible for submitting clinical trials in Europe, Africa, and the Middle East. Within EFPIA, she is a member of the CTIS SME group led by EMA, which includes sponsors and member states CTIS SMEs as well as being part of the cross-industry team on EU CTR and CTIS. Gaby is also part of the COMBINE workstream for EFPIA as a CTIS SME, driving the implementation of COMBINE in CTRO and Pfizer.

She is a member of the EFPIA CT Reg Pillar group and an ad-hoc participant of the EFPIA CREG and Transparency groups. Gaby has participated in the ACT EU ICH E6 (R3) workshop organized by EMA. She has been involved in the European regulatory evolution from pre-CTD to CTR and CTIS implementation, being a member of the Pfizer workstreams implementing EU CTR and a tester of CTIS since UAT 1 in early 2016. EUDAMED testing is the next step in relation to the COMBINE project.

Gabry Di Matteo has over 30 years of experience in Early Clinical Research and Regulatory submissions, having spent many years in the Pfizer Phase 1 Clinical Research Unit from its inception until CRU managing increasingly complex studies.

Strategies for successful combined (drug/device) study approvals in the EU

Strategies for successful combined (drug/device) study approvals in the EU

In vitro diagnostic tests are a key component in clinical trials with investigational medicinal products (IMP). However, many of these tests are not CE-marked or not used in accordance with their CE-mark within clinical trials. Such tests, when used for patient management decisions in the EU, are governed by the EU In Vitro Diagnostic Regulation (IVDR) and require the regulatory status of either an ‘in-house device’ or a ‘device for performance study’. This presentation provides medical writers with an introduction to both regulatory statuses under IVDR.

In most cases however, only the status of ‘device for performance study’ is possible, necessitating the conduct of a device performance study in parallel with the clinical trial, i.e., necessitating a combined study. Obtaining approval for these performance studies from national competent authorities and ethics committees has proven to be a significant challenge, slowing down clinical trial enrollments in the EU. Medical writers are in the hot seat to help build the study submission packages for the different EU countries where combined studies are planned. This session will provide an overview of regulatory hurdles – and solutions – to obtain performance study approvals in different EU countries. 

Anne Paulussen, Flen Health, Belgium
Anne Paulussen is a seasoned regulatory affairs expert with over a decade of experience spanning in vitro diagnostics (IVDs), combination products, and biotechnology. She specializes in strategic regulatory guidance for combined submissions of investigational drugs with investigational devices, with a strong focus on Companion Diagnostics (CDx) under the EU In Vitro Diagnostic Regulation (IVDR).
Anne has successfully guided start-ups bringing their IVDs to the EU market, and advised major pharmaceutical and diagnostic companies on Annex XIV IVDR applications. Her expertise extends to global regulatory strategy, FDA engagement, and clinical trial compliance and she is also an experienced speaker and trainer at industry conferences such as EMWA, RAPS and Healixia Clinical Trial conference.
Currently, Anne serves as Quality, Regulatory, and Clinical Affairs Director at Flen Health, overseeing a team navigating global regulatory challenges. As co-chair of RAPS Belgium LNG and a member of EMWA’s Medical Device SIG, she actively contributes to the regulatory community.
With a passion for knowledge-sharing and regulatory excellence, Anne is dedicated to helping companies bring innovative combination products and diagnostics to market while ensuring compliance with evolving regulations.
Pieter Bogaert, QbD Group, Belgium

Pieter holds a PhD in Biotechnology with an academic career as molecular immunologist and a technical expertise in flow cytometry. He became an in vitro diagnostics (IVD) consultant after holding several positions at an IVD manufacturer and a central laboratory contract research organisation (CRO) for clinical trials. At QbD Group, Pieter is currently a senior regulatory affairs consultant, specialised in IVD regulation, and ISO 13485 lead auditor. He supports IVD manufacturers from start-up companies to multinationals, as well as laboratories, in complying with Quality Management Systems (QMS) and IVD Regulation (IVDR) requirements. Pieter is also in the leadership team of the Belgian RAPS Local Networking Group.

Cybersecurity in Healthcare Products

Cybersecurity in Healthcare Products

The rapid advancement of medical technology brings increasing cybersecurity challenges. As medical devices and drug-device combination products integrate with wireless networks and cloud systems, they become prime targets for cyberattacks. A single breach can endanger patient safety, disrupt healthcare operations, and expose sensitive medical data.

Regulatory bodies provide cybersecurity guidelines, but compliance alone does not ensure protection. Developers must embed security throughout the product lifecycle by conducting risk assessments, implementing encryption, enforcing access controls, and continuously monitoring vulnerabilities.

Addressing these evolving threats requires collaboration between companies, healthcare providers, and cybersecurity experts. As cyberattacks grow more sophisticated, the industry adopted and is constantly refining security frameworks to safeguard medical technology. The question remains: in a world of ever-evolving threats, can we ever be truly secure?

Dragan Jovic, Re5 ApS, Denmark

Dragan Jovic is a military telecommunication engineer with expertise in military telecommunications, cybersecurity, and operational planning who transitioned to the Medical Device field.

He is currently employed as the Director of Quality and IT at a Danish medical device manufacturer, while also working as a regulatory consultant. With 9+ years of regulatory experience, he specialises in CE Marking, Software as a Medical Device, Risk Management, and Post-Market Surveillance. He has worked on cybersecurity in medical devices, ensuring compliance with ISO/IEC 27001 and Medical Device Regulation (MDR) cybersecurity requirements.

As a lead auditor (ISO 13485, ISO/IEC 27001), MDSAP auditor, and technical documentation assessor, he supports certification processes. He has extensive experience in health informatics, AI-driven medical solutions, and telecom-based telehealth systems.

Dragan lectures at the Serbian Institute for Standardisation, speaks at EMWA conferences, and has worked globally, including direct client projects in Denmark. His expertise includes FDA pre-market submissions (510k), software development (IEC 62304), and cybersecurity risk management.

Panel Discussion

Panel Discussion

Dr Jonathan Sutch, BSI Group, UK

Dr Jonathan Sutch is a principal medicinal specialist at the Notified Body BSI Group, working with medical devices containing medicinal substances and drug/device combinations. Jon trained as a Pharmacist at the London School of Pharmacy prior to completing a PhD in Pharmaceutical Sciences at Nottingham University. He has 15 years of experience in the pharmaceutical industry as a formulation scientist and manager before moving to BSI 7 years ago.

Dr. Fatima Bennai-Sanfourche, Bayer AG/Medtech & Pharma Platform, Germany

Dr. Fatima Bennai-Sanfourche currently serves as the Global Senior Director of QA&RA Compliance for Medical Devices, Combination Products, and eHealth at Bayer AG. In this role, she ensures regulatory compliance and high product quality across Bayer’s medical device and eHealth portfolio. She also oversees the compliant use of medical devices and software tools in clinical investigations and trials, adhering to Good Clinical Practice.

She has a rich background in the medical field, with over 20 years of experience in quality management, regulatory affairs, and the development of medical devices, including software, in vitro diagnostics, and combination products. Her career at Bayer began in the medical affairs and pharmacovigilance department, where she served as the Director of Medical Device Safety and Global Pharmacovigilance/Medical Device Safety Officer.

Her academic journey started with a focus on Biology, specialising in Biochemistry, Immunology, and Pharmacology. She earned her PhD in Pharmacology and Pharmacochemistry from Strasbourg, France. Dr. Fatima-Bennai-Sanfourche early professional life was dedicated to research and development in France, Sweden, and Germany, focusing on cerebrovascular diseases, hypertension regulation, and immunoassay development.

In addition to her current responsibilities, Dr. Fatima-Bennai-Sanfourche leads the implementation of the Medical Device Regulation (MDR) for PH-Bayer AG. She has been recognised for her expertise and contributions to the field, being nominated by the European Commission in 2019 as an EFPIA observer for the Post-Market Surveillance and Vigilance (PMSV) subgroup (GROW.D4). Since July 2021, she has been a member of the European Commission Post-Market Surveillance (PMS) task force, contributing to the preparation of MDR PMS guidance according to Article 83.

Dr. Fatima Bennai-Sanfourche is actively involved in several professional groups and initiatives, including:

  • Member of the Regulatory group of the EFPIA for medical devices.
  • Member of the EU Commission group for Clinical Investigation and Evaluation of medical devices (MDCG CIE).
  • Chair of the In vitro Diagnostic group at Medtech and Pharma Platform (MPP).
  • Member of the European Acceleration Clinical Trials (ACT EU) initiative chaired by the EMA.
  • Member of the ACT EU Multi-stakeholder Platform Advisory ad-hoc Group.
  • Member of the RWD used in pragmatic trial group at TransCelerate.

Her extensive experience and leadership in the pharmaceutical, medical device, and regulatory fields make her a pivotal figure in the Medtech and pharma regulatory landscape in Europe.

Dragan Jovic, Re5 ApS, Denmark

Dragan Jovic is a military telecommunication engineer with expertise in military telecommunications, cybersecurity, and operational planning who transitioned to the Medical Device field.

He is currently employed as the Director of Quality and IT at a Danish medical device manufacturer, while also working as a regulatory consultant. With 9+ years of regulatory experience, he specialises in CE Marking, Software as a Medical Device, Risk Management, and Post-Market Surveillance. He has worked on cybersecurity in medical devices, ensuring compliance with ISO/IEC 27001 and Medical Device Regulation (MDR) cybersecurity requirements.

As a lead auditor (ISO 13485, ISO/IEC 27001), MDSAP auditor, and technical documentation assessor, he supports certification processes. He has extensive experience in health informatics, AI-driven medical solutions, and telecom-based telehealth systems.

Dragan lectures at the Serbian Institute for Standardisation, speaks at EMWA conferences, and has worked globally, including direct client projects in Denmark. His expertise includes FDA pre-market submissions (510k), software development (IEC 62304), and cybersecurity risk management.

Anne Paulussen, Flen Health, Belgium
Anne Paulussen is a seasoned regulatory affairs expert with over a decade of experience spanning in vitro diagnostics (IVDs), combination products, and biotechnology. She specializes in strategic regulatory guidance for combined submissions of investigational drugs with investigational devices, with a strong focus on Companion Diagnostics (CDx) under the EU In Vitro Diagnostic Regulation (IVDR).
Anne has successfully guided start-ups bringing their IVDs to the EU market, and advised major pharmaceutical and diagnostic companies on Annex XIV IVDR applications. Her expertise extends to global regulatory strategy, FDA engagement, and clinical trial compliance and she is also an experienced speaker and trainer at industry conferences such as EMWA, RAPS and Healixia Clinical Trial conference.
Currently, Anne serves as Quality, Regulatory, and Clinical Affairs Director at Flen Health, overseeing a team navigating global regulatory challenges. As co-chair of RAPS Belgium LNG and a member of EMWA’s Medical Device SIG, she actively contributes to the regulatory community.
With a passion for knowledge-sharing and regulatory excellence, Anne is dedicated to helping companies bring innovative combination products and diagnostics to market while ensuring compliance with evolving regulations.
Pieter Bogaert, QbD Group, Belgium

Pieter holds a PhD in Biotechnology with an academic career as molecular immunologist and a technical expertise in flow cytometry. He became an in vitro diagnostics (IVD) consultant after holding several positions at an IVD manufacturer and a central laboratory contract research organisation (CRO) for clinical trials. At QbD Group, Pieter is currently a senior regulatory affairs consultant, specialised in IVD regulation, and ISO 13485 lead auditor. He supports IVD manufacturers from start-up companies to multinationals, as well as laboratories, in complying with Quality Management Systems (QMS) and IVD Regulation (IVDR) requirements. Pieter is also in the leadership team of the Belgian RAPS Local Networking Group.

8:45 am to 12:30 pm

PTF21 Health-related quality of life

The workshop will give an overview of the different types of health-related quality of life instruments (HRQoL) instruments and the main issues to be considered when using these measures in clinical studies. Participants will gain an understanding of how to appraise HRQoL measures and report their use in studies. We will also explore various approaches for generating the HRQoL data that are used in cost-utility analysis.
Participant profile: This workshop is aimed at medical writers who deal with HRQoL or patient-reported outcome measures (PROMs) in clinical studies or document writing. No prior experience with HRQoL instruments is needed.
Claire Gudex

Claire is associate professor in Academic Writing and health service researcher in the area of patient outcome measurement. She has a medical degree and worked for 10 years at the Centre for Health Economics, University of York, UK, before moving to Denmark in 1995. Here, she has worked at WHO Regional Office, National Institute of Public Health, and the University of Southern Denmark. Claire is a founder member of the EuroQol Group, an international research group for the development of the generic health measure, EQ-5D.

MSF6 Why do drugs and medicines have adverse effects?

This workshop is designed to explain the reasons behind the commonest types of adverse effects of drugs and medicines. This is intended to enable participants to understand and often predict adverse effects of new drugs and medicines. This will make it easier for participants to write accurately and effectively about the adverse effects of the drugs and medicines they will meet in their work.
Participant profile: Participants should, ideally, have already completed Introduction to Pharmacokinetics (DDF7) and Pharmacology for Medical Writers: Part 1 – The Basics (MSF1), or have equivalent experience or knowledge.
John Carpenter

John, a pharmacologist, was a lecturer in pharmacology at Manchester University from 1974 to 1992, where he studied drugs and the movement of ova through oviducts, anti-asthma drug models, and the pharmacokinetics of alcohol (never a shortage of volunteers). He has written or contributed to several pharmacology textbooks, and acted as an expert witness in court cases involving alcohol. In 1992, he became a full-time medical writer, initially with Gardiner-Caldwell Communications, then as Medical Team Director at Medical Action Communications and briefly as Medical Director at OCC. From 2001, he was a freelance medical writer, medical communications consultant, and trainer. John is a regular contributor to the range of training courses offered by the Proper Medical Writing Group in Poland and by Kemic Bioresearch in Canada. Satisfied customers include the Canadian Government’s medicines regulatory department. He has served on the EMWA Executive Committee as Universities Liaison Officer and was a member of the EMWA Professional Development Committee (EPDC) from 2005 to 2010. John retired (for the fourth time) in February 2023 and was proud to receive a Nick Thompson Fellowship in May 2023.

NEW LWF23 Efficiency in Medical Writing: The Lean Approach

Objective
Participants will gain insight into the advantages of lean medical writing and its alignment with regulatory expectations, thereby emphasizing the importance of efficient and concise documentation. Participants will be introduced to various opportunities for lean writing, such as use of cross-references, deductive writing, reducing appendices, and avoiding descriptive text and redundancies in favour of result interpretation.
Content
Lean writing techniques: The principles of lean writing and its application in medical writing will be presented. We will utilize applicable templates (e.g. the TransCelerate CSP/CSR templates) with practical examples and case studies to illustrate the benefits and impact on regulatory compliance.
Efficient cross-referencing and redundancy mitigation: We will explore effective cross-referencing techniques across clinical documents within the specified scope. Our focus will be on minimizing redundancies, reducing the number of appendices, and consequently reducing document size.
Reviewer and regulatory emphasis: Participants will gain insights into concentrating on essential information necessary for approval, while learning to avoid unnecessary details. This approach aims to facilitate a more straightforward review process for assessors. Strategies for managing an excess of (exploratory) analyses will also be discussed.
Expanding lean writing opportunities: We will introduce opportunities for employing deductive medical writing in CSRs and Module 2 documents, emphasizing result interpretation over descriptive writing, and providing practical strategies for implementation.
Participant profile: This workshop is intended for medical writers who are relatively new to preparing clinical documents, as well as for more advanced writers. Participants should have a basic understanding of the drug development process and its clinical documents such as CSPs, CSRs, summaries, and overviews, and how they relate to each other.
Iris Bresink

With over 25 years of clinical development experience, including more than 20 years in medical writing and 5 years in regulatory affairs, Iris brings a wealth of knowledge and experience. Iris is an authorized pharmacist with a Ph.D. in pharmacology. Her medical writing experience includes developing and authoring clinical overviews, summaries of clinical efficacy and safety for NDAs/BLAs/MAAs, as well as life cycle management and various regulatory documents. She has extensive therapeutic experience across multiple areas. In recent years, Iris has played a key role in developing standards within the Medical Writing area of a larger pharmaceutical company and providing training for medical writers, particularly in strategic and regulatory writing. In 2024, Iris decided to start her own medical and regulatory writing business.

Suvi Rajamaki

With several years of medical writing and academic research experience, Suvi brings a wealth of knowledge and experience in authoring different document types, both in regulatory and scientific areas. Suvi has a Ph.D. in synthetic organic chemistry, and in nanotechnology and functional materials. Her medical writing experience includes developing and authoring clinical study protocols, study reports and summaries of clinical efficacy and safety for INDs /NDAs /MAAs. She has extensive therapeutic experience across multiple areas.

DDF54 Non clinical study reports

Participants of this workshop will receive an overview of the regulatory guidelines and individual parts of the non-clinical study report (NCSR) and relevant source documents, as well as submission requirements. Thereby, the medical writer’s role in the preparation of the NCSRs will be highlighted.
Participant profile: NCSR is a comprehensive document that presents the findings and results of studies conducted on substances or products in preclinical or laboratory settings. Hence, those who stand to benefit from this workshop are regulatory personnel and scientific/medical writers in the pharmaceutical industry, those at CROs or medical writing agencies involved in regulatory documentation, or within academic groups/technology transfer departments at universities, etc.
Sally Hill

Sally is based in the Netherlands where she works as Senior Scientific Writer at a small Utrecht-based biotechnology company. Her background includes experience in the lab as a molecular biologist, in the classroom as a university lecturer in scientific writing, and in consultancy as a translator/editor/writer of medical and scientific texts. Sally’s move into the pharmaceutical industry has given her a deep dive into non-clinical writing and regulatory submissions within oncology. A longstanding member of EMWA and a keen networker, she has helped to set up a Dutch network of scientific and medical writers and is an active participant of EMWA’s Regulatory Special Interest Group. She previously served as Chair of SENSE, the Society of English-language professionals in the Netherlands.

Carola Krause

Carola Krause is an Associated Principal Medical Writer at Trilogy Writing & Consulting, focusing on non-clinical and clinical regulatory writing. Based in Potsdam, Germany, she has a postdoctoral background in molecular stem cell biology and extensive hands-on experience in academic and pharmaceutical research, project management, and all stages of drug development.

As a long-term EMWA member, Carola has contributed to its educational program, founded and chaired the Creative Team and the Sustainability Special Interest Group, and served as EMWA’s President (2020–2022). She continues to represent EMWA as an ambassador and AI liaison for the Visual Communications Special Interest Group.

MCA9 Publication ethics and compliance

To foster ethical and compliant behaviour in publications, and to enable writers to understand, appreciate, and apply the current industry-wide standards of good publication practices.
Participant profile: This workshop is intended for anyone interested in learning about ethical, compliant, and transparent behaviour in the preparation of peer-reviewed scholarly publications. It will focus on Good Publication Practice (GPP) recommendations and guidelines from committees, such as the Committee on Publication Ethics (COPE) and the International Committee of Medical Journal Editors (ICMJE). These are particularly relevant for pharma-sponsored congress presentations and manuscripts. Participants should have a basic understanding of the publication process, from conception to submission.
Sergey Sulima

Sergey holds a PhD in molecular and cell biology from the University of Maryland, USA (2013) and completed postdoctoral research in oncology and hematology at the University of Leuven, Belgium. He has authored 16 publications in leading journals including Cancer Discovery, Leukemia, and Nature. From 2018 he held pharmaceutical industry roles first as a medical writer at BioNTech and then publications lead at Bristol Myers Squibb in Germany. Since 2024, he has been employed as Associate Director of Global Medical Communications at Regeneron Pharmaceuticals in Munich, Germany, overseeing oncology medical communications for the DACH region. Sergey is an active member of ISMPP and holds their Certified Medical Publication Professional (CMPP™) certificate. He joined EMWA in 2018 and has served as an EMWA workshop leader since 2020 and an EPDC member since 2023.

PTF5a Medical Writing and Quality Control of Documents Entering the Public Domain: Manuscripts and Abstracts

For a medical writer with documents destined to enter the public domain a QC process is essential. A properly implemented QC process helps reduce errors in the factual presentation of data, and when writing a manuscript ensures an accurate document structure is followed to fulfil a journal’s specific requirements. The workshop will focus on developing a QC process for non-regulatory documents, particularly manuscripts, and detail several strategies to achieve this.
Participant profile: The workshop is particularly suited to medical writers who are writing documents entering the public domain. It will be most useful for those who either have no quality control (QC) system in place, or are now looking to develop one. For medical writers with greater experience it will provide a forum for discussion and sharing best practice. The workshop content is relevant to those working in a freelance capacity, as well as medical writers employed by CROs, communications agencies, or pharmaceutical companies.
Stephen Gilliver

Stephen (Steve) Gilliver has been an EMWA member for 15 years and is a former Co-Editor of the EMWA journal, Medical Writing. He has spent the past 16 years working as an editor and medical writer. Having moved from the UK to Sweden in 2010, he ultimately settled in Malmö, where he now works home-based as a Manager, Medical Writing, specializing in publications (manuscripts, abstracts, posters). He is a joint British-Swedish citizen and speaks fluent Swedish.

Athanasia Benekou

Athanasia (“Atha”) Benekou is a Principal Medical Writer in the PPD clinical research business of Thermo Fisher Scientific. She has over 20 years of medical writing experience, including 12 years as a freelancer, 7 years as a pharmaceutical company employee, and 5 years in the CRO environment. Athanasia has led and contributed to the writing of a variety of scientific documents, including manuscripts and regulatory documents. In parallel, since 2002, she has set up and led a variety of trainings and workshops on medical writing topics such as Good Publication Practice guidelines, evidence-based medicine, publication ethics, and critical appraisal of research papers.

DDA28a The Investigational Medicinal Product Dossier: a critical component of the Clinical Trial Application

Participants of this workshop will get an overview on the individual parts of the IMPD, as well as details of the relevant source documents. In addition, participants will be informed about the medical writer’s role in the preparation of the IMPD.
Participant profile: The Investigational Medicinal Product Dossier (IMPD) is an important component of the clinical trial application (CTA) which is submitted for approval of clinical trials on investigational medicinal products (IMPs) in the EU. Those who stand to benefit from this workshop are regulatory personnel and medical writers in the pharmaceutical industry, CROs, and medical writing agencies who are involved in preparing regulatory documentation.
Participants of this workshop will be expected to have basic knowledge, if not experience, of the drug development and approval process, especially in the US and the EU.
Satyen Shenoy

Satyen Shenoy come from a background in pharmaceutical and biomedical research in academia and industry in India, the US, and Germany. Satyen ventured into medical writing in 2010 as a contractor with Sanofi before starting his independent consultancy in 2015 to offer a wide array of writing services, including regulatory documentation. Satyen has been an EMWA member since 2012 and an active volunteer on EMWA’s Freelance Business Group, Expert Seminar Series committee, and more recently served as the EMWA President 2022-3. Satyen has recently joined Trilogy Writing & Consultancy GmbH as an Associate Principal Medical Writer.

LWF22 Inclusive Language in Medical Writing: How are our words perceived when we communicate?

Why should equality be a priority for all of us? Genuine intentions are essential to tackle diversity—when the purpose is not genuine, one ends up with little more than tokenism or empty words.
Equality and inclusive language go hand in hand. Inclusive language is complex and seeks to embrace diversity and treat all people with respect, dignity, and impartiality. What is more complex than diversity?
What nuances of inclusive communication should medical writers be aware of when drafting texts, and how to advocate for inclusive language among our peers and stakeholders?
Participant profile: This workshop is aimed at improving the inclusive language  sensitivity of medical writers. Previous attendance at another workshop is not required.
Laura Collada Ali

Laura is a seasoned Medical Writing Manager with over 24 years of experience in the pharmaceutical and medical device industries. She specialises in overseeing the creation and timely delivery of study documents, including protocols, informed consent documents, and clinical study reports. Laura also supports medical device manufacturers by drafting clinical evaluation reports and related documentation. Her expertise spans from patient-facing documents to medical communications and regulatory writing. A proponent of the “patient first movement,” Laura prioritises clear and inclusive communication for patient benefit. She is actively involved in the European Medical Writers Organization (EMWA), serving as an EPDC member.

Heather L. Mason

Heather worked in both clinical operations and medical affairs departments for eight years before turning to medical writing in 2010. She has been a freelance writer since 2018, working in a wide range of therapeutic areas for pharma, biotech, not-for-profit, and patient organisations. Her specialist area of interest is rare diseases, and she writes predominantly in medical communications, ranging from conference coverage and manuscripts to patient-focused materials and whole project management. Since working on rare diseases and having a son with a disability, she has a passion for patient advocacy, understanding first-hand how non-inclusivity can adversely affect the day-to-day lives of people.

DDF17a Ethical Issues in Clinical Trials

To give an overview of the various ethical considerations associated with conducting clinical trials and associated policies and processes, including institutional oversight, pre-approval access, regulatory authority clearance, subject informed consent, investigatory conflict of interest, issues of fraud, and ensuring subject safety and well-being.
Participant profile: This workshop is intended for medical writers (and others) who are interested in clinical trials and would like to know more about the evolution of ethical principles associated with human subject participation. Global ethical aspects that are taken into consideration for studies will be reviewed. In addition, case examples of situational clinical trial and medical ethics will be provided for interactive discussion.
Art Gertel, MedSciCom, LLC

Art has a background in neurophysiology and behavioural medicine. As an independent consultant, he specialises in regulatory strategy, Data Safety Monitoring Board management, medical writing, and bioethics. Art has held senior posts at a number of companies including Schering-Plough/Merck, Hoffmann-LaRoche, TFS, and Quintiles, and headed departments responsible for medical writing, publications, project management, and regulatory affairs. He also served as a Senior Research Fellow with the Centre for Innovation in Regulatory Sciences (CIRS). Art has extensive teaching experience and has presented to professional organisations (e.g. EMWA, AMWA, DIA), and corporate and academic audiences, worldwide. He spent 2 years heading Clinical Operations for an eDC ‘dot.com’ company, and has been active in Clinical Data Interchange Standards Consortium (CDISC) since its inception. He served as Chair of the Global Ethics and Regulatory Initiative (GERI) of the Alliance for Clinical Research Excellence and Safety (ACRES). He is a Founding Member of the Global Alliance of Publication Professionals (GAPP), a Past President of AMWA, and a Fellow of both AMWA and EMWA. Art served in a Senior Advisory capacity on the Budapest Working Group in developing the CORE Reference. He has a particular interest in bioethics in the context of clinical studies, is an adviser to an IRB, and serves on a number of task forces focusing on improving the drug development process while protecting the rights and safety of clinical study participants.

 

MCA8 The Value Story and the Global Value Dossier

After completing the workshop, you should understand the concept of ‘value’ and be able to construct a value story and value messages for a pharmaceutical product or medical device. You will be familiar with the structure of a typical value dossier and have an understanding of what information is required in each section. You will understand what a value dossier is used for and how to make sure it fulfils users’ needs.
Participant profile: Anyone who wants to learn more about value messages and writing value dossiers, whether they are new to these topics or have some experience with them. The workshop will not assume any prior knowledge of value dossiers or market access, but will assume a basic familiarity with drug development and clinical data.
Jo Whelan

Jo has over 25 years’ experience in medical writing, and is currently Value Communication Principal at Visible Analytics Ltd. She specialises in writing for market access, health economics, and outcomes research. She has led, managed, and written a wide variety of projects for pharmaceutical companies, market access consultancies, and medical communications agencies, including health technology assessment submissions, value stories, manuscripts, literature research projects and more. In a previous life, she has written numerous news and feature articles for the scientific and consumer health press, and is author of four health-related books for teenagers. She has a particular interest in oncology and holds an MSc in Cancer Therapeutics from Barts Cancer Institute, Queen Mary University of London. Jo served as EMWA Education Officer from 2011 to 2014.

12:30 pm - 1:15 pm

The efficiency boost anticipated with AI and the MW value from a CRO’s perspective

In this lunchtime seminar, you’ll discover:

  • How the medical writing industry is transitioning from manual document development to a streamlined, content-based approach
  • The power of Structured Content Authoring (SCA) in improving efficiency and consistency in clinical and regulatory documentation
  • Real-world implementation results from Parexel Medical Writing Services
  • The game-changing integration of Generative AI with SCA and its impact on clinical content production

Key Highlights:

  • Learn how SCA decreases document production time and enhances first-time quality
  • Explore the benefits of metadata-driven standardized content and configurable templates
  • Understand how GenAI augmentation reduces adoption barriers and offers enhanced flexibility in content generation

Don’t miss this opportunity to stay ahead of the curve in medical writing technology!

Mati Kargren

Mati Kargren currently serves as a Medical Writing Optimization Lead, GSK, where he drives strategic initiatives to enhance regulatory document development processes and technological integration. Prior to this role, Mati held the position of Medical Writing Services Technology Consultant at Parexel International, where he spearheaded the implementation of a department-wide structured content management (SCM) platform and led the integration of generative AI capabilities to optimize clinical study content creation workflows.

At Parexel, he was instrumental in developing and executing a comprehensive content strategy and AI prompting framework through a strategic partnership with a major pharmaceutical client. This initiative established best practices for leveraging advanced technologies in regulatory documentation.

Mati is recognized for his expertise in emerging technologies for medical writing and his commitment to advancing the strategic role of medical writing professionals in global pharmaceutical development. His work focuses on identifying and implementing innovative solutions that enhance efficiency, quality, and compliance in regulatory documentation. He is based in Taipei, Taiwan.

1:30 pm - 3:00 pm

Reactive and Proactive Strategies for Expedited Protocol Amendments under EU-CTR – EDG

The European Union Clinical Trials Regulation (EU-CTR), EU No. 536/2014, has replaced the EU Clinical Trials Directive (EU‑CTD), EC No. 2001/20/EC, for clinical trial applications in the EU. Under the new regulation, after submitting a trial dossier to the European Medicines Agency (EMA), sponsors receive Requests for Information (RFIs) following dossier assessment by EMA member states. Typically, the RFI response period is only 12 calendar days (approximately 8 working days). This timeline is challenging as the RFI response may include a protocol modification (amendment) and updates to associated documents (Lay Protocol Summary and redacted protocol version), as well as translations. This Expert Discussion Group will draw on the participants’ experiences in and strategies for RFI-related protocol modifications.

The focus will be on:

  1. Reactive strategies for addressing RFIs in protocol amendments:
    1. Achieving team consensus on the RFI response
    2. Strategy for expediting protocol amendment development
  2. Proactive strategies for mitigating risks of RFIs on the protocol:
    1. Team preparation and a planned expedited process for CSP modification
    2. Updates to protocol template based on experience with RFIs

Addressing these demands requires extensive cross-functional collaboration between all stakeholders. The aim of the group discussion is to propose best practices for managing protocol modification. By sharing experiences and insights, this Expert Discussion Group will seek to provide practical solutions for navigating the complexities of the EU-CTR and its impact on protocol development and management.

Participant profile: Expert Discussion Groups (EDGs) are group discussions led by a moderator/moderators, and the moderators will pose 2-3 questions ahead of the discussion on one topic to lead the discussion or to bring the discussion back to topic. There will be a max of 10 attendees, and we ask the moderators to set experience levels to keep the discussion standards and the level high. These sessions will be 1.5 to 2 hours.
Anuradha Alahari

Regulatory medical writer in a global, Contract Research Organisation. More than 10 years of experience in preparation and management of Clinical Study Protocols (CSPs) and CSP modifications (amendments); and approximately 2 years of experience in supporting European Union Clinical Trials Regulation (EU-CTR) compliant CSPs and CSP modifications.

1:30 pm to 5:00 pm

Organisers: Namrata Singh & Archana Nagarajan, Med Comms & Entp SIG

The medical writing industry, and clients’ expectations of medical writers, are rapidly evolving. Medical writing agencies and the medical writers who work for them are increasingly expected to work on projects that go beyond core medical writing activities. This can include providing broader business solutions and creating strategies to overcome specific challenges with aligned global and local content. Effective localisation of medical writing must involve consideration of cultural nuances, not simply translating text into native languages. Furthermore, increasing use of multichannel approaches also means that medical writers must be comfortable with creating content for various digital platforms, including understanding how they work and their audience’s expectations. Finally, the explosion of artificial intelligence means medical writers must learn new skills to remain competitive, and may need to collaborate with developers/IT professionals involved in developing new tools to support the future of the industry.

Introduction

Introduction

Namrata Singh

MBA is a physician turned medical writer with a passion to communicate science and medicine to different audiences: Right content for the right audience and at the right platform. She is the founder of Turacoz Group which provides strategic solutions to biopharma companies, medical technology firms, healthcare professionals, and research institutes around medical writing, evidence generation, insights gathering and medical education.

She has been involved in mentoring and training medical writers including the recent technology advancements. She is an active member of societies like European Medical Writers Association (EMWA), American Medical Writers Association (AMWA) and International Society of Medical Publication Professionals (ISMPP). She is the chair of AI working group and Entrepreneurship Special Interest Group at EMWA. She participates as speaker, organizing member and has authored publications around medical writing. She is based in Utrecht, The Netherlands.

Beyond Translation: A Holistic View of Localisation in Medical Communication (Will cover 3 different dimensions: translation, localisation, and writing directly in the native language)

Beyond Translation: A Holistic View of Localisation in Medical Communication (Will cover 3 different dimensions: translation, localisation, and writing directly in the native language)

In medical communication, crafting content that resonates with local audiences requires more than simply translating words. It involves balancing linguistic accuracy, cultural nuances, regulatory requirements, and audience expectations – a complex process that spans three key dimensions: translation, localisation, and writing directly in the native language. Each dimension plays a distinct role, and understanding when to translate, localise, or write from scratch is crucial to producing high-quality content.


This session offers an engaging and holistic view of localisation, going beyond the basics of language and culture. It examines how translation ensures technical accuracy, how localisation adapts content to local realities, and how writing enhances clarity, engagement, and authenticity. Practical insights into the broader localisation process will illustrate how global content can be transformed into precise, context-sensitive local communication. 

The discussion focuses on the strategic decisions behind content development, offering new perspectives on managing the multidimensional challenges of creating content that truly resonates with local audiences.

Ana Sofia Correia, Freelance, Portugal

Ana Sofia Correia is an English-to-Portuguese medical translator and writer based in Portugal. Over the past 18 years, she has collaborated with life sciences companies, contract research organisations, language service providers, and medical communication agencies. After 12 years as an in-house translator at the Centre for Social Studies of the University of Coimbra and the Nursing School of Coimbra, she transitioned to full-time freelancing in 2019. Alongside her translation, writing, and linguistic validation services, she authors the newsletter Perspectives on Medical Translation & Writing and co-authors the blog Med & Mark. Since 2023, she has been leading Medical Translation Mentoring, a mentoring programme dedicated exclusively to the community of translators specialising in medical and life sciences. In 2024, she was appointed Vice-President of the Portuguese Medical Writers Association (APMW).

Organically growing the social media feed: Mission impossible? (Including secrets of producing high-quality content for industry stakeholders and making both clients and readers happy)

Organically growing the social media feed: Mission impossible? (Including secrets of producing high-quality content for industry stakeholders and making both clients and readers happy)

Companies want to leverage social media to promote their brand, but getting one’s message across in a more and more saturated digital landscape is hard. How do we help industry stakeholders create content that attracts attention organically, and, on top of that, manage the intricacies of collaborating with the client’s team to provide content that both communicates the company’s message and resonates with the followers? 

From finding the right channels and building a presence to choosing the publication language(s), in this talk, communications expert and writer Pauliina Rasi shares the secrets of producing high-quality content for industry stakeholders and making both clients and readers happy.

Pauliina Rasi

Pauliina Rasi is a writer, communication strategist, and trainer. With 20 years of experience as a journalist and communications consultant, she helps businesses, projects and professionals find the right words to get their message across in a busy digital landscape. She distils her experience in health journalism, corporate communications, and public relations to help her clients produce engaging and educating content that enlightens and enchants readers across Europe.

Crafting Impactful Medical Communications Through Storytelling (The session explores practical techniques to craft narratives that resonate with audiences and achieve communication objectives)

Crafting Impactful Medical Communications Through Storytelling (The session explores practical techniques to craft narratives that resonate with audiences and achieve communication objectives)

In the realm of medical communications, where complex scientific information must be conveyed clearly and memorably, effective storytelling is an invaluable tool. This session will delve into the art of storytelling in medical writing, exploring practical techniques to craft narratives that resonate with audiences and achieve communication objectives.

To do this, we will use the PRISM framework, developed by Eleanor Steele, to ensure we are considering specific key factors effectively to create compelling narratives. Using example medical writing projects, we will discover how the intentional use of these factors can help us adapt storytelling approaches for diverse audiences and content types, ensuring clarity and fostering engagement. Join us to unlock the power of storytelling in medical writing and elevate your ability to communicate complex scientific information effectively.

Eleanor Steele, MedComms

Eleanor Steele has worked in medical communications (MedComms) since 2004, first as a medical writer, then leading scientific teams in several different agencies. She is now a freelance consultant working as the MedComms Mentor to provide specialist training and mentoring to medical writers and consultancy to agencies around building, nurturing, and developing their medical writing teams. Since April 2024, she has also managed the MedComms Workbook subscription service for MedComms freelancers.

Mastering AI in Medical Writing: Tools, Techniques, and Trends (focus on how to structure prompts and address the evolving job market for medical writers)

Mastering AI in Medical Writing: Tools, Techniques, and Trends (focus on how to structure prompts and address the evolving job market for medical writers)

Artificial intelligence (AI) is transforming the landscape of medical writing and editing, offering unprecedented opportunities to enhance accuracy, productivity, and security. However, leveraging AI effectively requires developing expertise with respect to its capabilities and limitations. This session  will explore how medical writers can integrate AI tools into workflows to achieve better outcomes while addressing critical industry changes. Through practical examples, attendees will learn how to structure prompts effectively to maximize the potential of tools like ChatGPT and Claude, ensuring high-quality, relevant outputs tailored to the unique demands of medical writing and work with various research tools to deliver optimal results. The session will also address the evolving job market for medical writers, examining how AI is reshaping roles and opening new opportunities for those equipped with the right skills. 

Dr. Emma Hitt Nichols, Nascent Medical, USA

Dr. Emma Hitt Nichols is a medical writer and editor and has been serving medical communications and publishing companies for more than 20 years. She holds a PhD in cancer-related cell signaling, an MS in technical and professional communication, and a BS in biology.

In 2015, Dr. Hitt Nichols founded Nascent Medical, with medical writers serving CME/CPD companies and medical communications agencies, and has grown that to a large medical writing team. She has also developed multiple courses to help train medical writers and editors over the years, including her most recent addition.

Emma lives in Jacksonville Beach, Florida, with her husband and 2 cats, enjoying the tumultuous seascape of the Atlantic Ocean as she brings her clients’ projects to life.

Reach out on LinkedIn: https://www.linkedin.com/in/emmahittnichols/

Embracing the Brave New World: Building AI Systems to Transform Medical Communication and Scientific Writing

Embracing the Brave New World: Building AI Systems to Transform Medical Communication and Scientific Writing

The medical communications landscape is undergoing a paradigm shift as AI technologies become central to addressing the accelerating pace of evidence generation and the inefficiencies of traditional content development workflows. As organisations embrace this transformation, medical writers and communication specialists face new challenges in maintaining compliant and high-quality deliverables while adapting to AI-augmented processes. This session examines the essential technical and operational foundations needed to achieve meaningful AI integration in scientific writing and medical communications. We’ll explore how structured content frameworks, semantic enrichment, and standardised workflows enable organisations to build reliable and reproducible AI systems that enhance rather than compromise content quality. Through practical examples, we’ll demonstrate how these foundational elements support compliant content creation while transforming traditional author-reviewer dynamics. The session will address the evolving expectations from partners and stakeholders, offering insights into how medical communication professionals can prepare for and thrive in this transformed ecosystem. We’ll examine both the immediate practical considerations and the longer-term strategic implications of AI adoption in scientific writing, helping professionals navigate this transition while maintaining the high standards demanded by the healthcare industry.

Participants will gain insights into:

  • Current challenges in evidence management workflows and the imperative for evolution
  • Technical foundations needed to achieve reliable and reproducible AI systems
  • How roles and stakeholder dynamics will transform in an AI-augmented ecosystem
  • Practical steps toward implementing AI while maintaining quality and compliance
Sepanta Fazaeli

Sepanta Fazaeli is Head of AI Solutions for Life Sciences at TransPerfect, where he leads the design and delivery of AI-powered solutions for pharmaceutical, biotech, and medical device organizations. His work spans the full spectrum of life sciences AI, from regulated document authoring and regulatory intelligence to safety surveillance, compliance automation, and conversational AI for clinical and regulatory workflows.

Before joining TransPerfect, Sepanta served as Clinical Systems & Medical Data Lead at Stryker, where he led enterprise-wide AI and data transformation initiatives across the Trauma & Extremities division, bridging clinical, regulatory, and technical domains. He also represented Stryker on the MedTech Europe AI Act Task Force, contributing to cross-industry efforts to shape practical, risk-based implementation of the EU AI Act for medical devices.

With a background in bioengineering and clinical data science, Sepanta brings both domain depth and technical fluency to the challenge of AI adoption in regulated environments. His approach centers on aligning people, processes, and technology to help life sciences organizations move from isolated pilots to integrated, enterprise-scale intelligence.

Panel Discussion

Panel Discussion

Ana Sofia Correia, Freelance, Portugal

Ana Sofia Correia is an English-to-Portuguese medical translator and writer based in Portugal. Over the past 18 years, she has collaborated with life sciences companies, contract research organisations, language service providers, and medical communication agencies. After 12 years as an in-house translator at the Centre for Social Studies of the University of Coimbra and the Nursing School of Coimbra, she transitioned to full-time freelancing in 2019. Alongside her translation, writing, and linguistic validation services, she authors the newsletter Perspectives on Medical Translation & Writing and co-authors the blog Med & Mark. Since 2023, she has been leading Medical Translation Mentoring, a mentoring programme dedicated exclusively to the community of translators specialising in medical and life sciences. In 2024, she was appointed Vice-President of the Portuguese Medical Writers Association (APMW).

Pauliina Rasi

Pauliina Rasi is a writer, communication strategist, and trainer. With 20 years of experience as a journalist and communications consultant, she helps businesses, projects and professionals find the right words to get their message across in a busy digital landscape. She distils her experience in health journalism, corporate communications, and public relations to help her clients produce engaging and educating content that enlightens and enchants readers across Europe.

Eleanor Steele, MedComms

Eleanor Steele has worked in medical communications (MedComms) since 2004, first as a medical writer, then leading scientific teams in several different agencies. She is now a freelance consultant working as the MedComms Mentor to provide specialist training and mentoring to medical writers and consultancy to agencies around building, nurturing, and developing their medical writing teams. Since April 2024, she has also managed the MedComms Workbook subscription service for MedComms freelancers.

Dr. Emma Hitt Nichols, Nascent Medical, USA

Dr. Emma Hitt Nichols is a medical writer and editor and has been serving medical communications and publishing companies for more than 20 years. She holds a PhD in cancer-related cell signaling, an MS in technical and professional communication, and a BS in biology.

In 2015, Dr. Hitt Nichols founded Nascent Medical, with medical writers serving CME/CPD companies and medical communications agencies, and has grown that to a large medical writing team. She has also developed multiple courses to help train medical writers and editors over the years, including her most recent addition.

Emma lives in Jacksonville Beach, Florida, with her husband and 2 cats, enjoying the tumultuous seascape of the Atlantic Ocean as she brings her clients’ projects to life.

Reach out on LinkedIn: https://www.linkedin.com/in/emmahittnichols/

Sepanta Fazaeli

Sepanta Fazaeli is Head of AI Solutions for Life Sciences at TransPerfect, where he leads the design and delivery of AI-powered solutions for pharmaceutical, biotech, and medical device organizations. His work spans the full spectrum of life sciences AI, from regulated document authoring and regulatory intelligence to safety surveillance, compliance automation, and conversational AI for clinical and regulatory workflows.

Before joining TransPerfect, Sepanta served as Clinical Systems & Medical Data Lead at Stryker, where he led enterprise-wide AI and data transformation initiatives across the Trauma & Extremities division, bridging clinical, regulatory, and technical domains. He also represented Stryker on the MedTech Europe AI Act Task Force, contributing to cross-industry efforts to shape practical, risk-based implementation of the EU AI Act for medical devices.

With a background in bioengineering and clinical data science, Sepanta brings both domain depth and technical fluency to the challenge of AI adoption in regulated environments. His approach centers on aligning people, processes, and technology to help life sciences organizations move from isolated pilots to integrated, enterprise-scale intelligence.

1:30 pm to 5:00 pm

DDF4a An Introduction to Informed Consent Forms

The concept of informed consent is a key part of Good Clinical Practice and the ethical principles that have their origin in the Declaration of Helsinki. The vocabulary and style that medical writers normally use, usually tailored for a scientifically educated audience, may not be appropriate for use in informed consent documents. Medical writers who create informed consent documents must adopt a writing style suitable for communicating with the public. On completion of this workshop package, participants should be able to write an informed consent document suitable for use in a clinical trial.

The workshop will start with some information about the historical rationale and ethical principles of informed consent. An overview of the different types of informed consent document will be provided and the regulatory requirements underpinning content, with a specific focus on data privacy, will be discussed. A general process for informed consent form preparation and a suggested general structure will be shared. The workshop will continue with some guidance on style and communicating with trial participants; special emphasis will be placed on identifying and avoiding jargon. Workshop exercises will be used to practice modifying typical source information into wording suitable for inclusion in an informed consent document.

Participant profile: This workshop is aimed at writers who are new to writing informed consent documents.
Stephen Moore

Stephen started working as a medical writer in 2012, having completed a PhD in chemistry at the University of Southampton. His first medical writing role comprised a mixture of medical affairs and publications work within a medical communications agency based in Oxford. After a few years, he switched to regulatory writing within a large contract research organization. In his current role as a medical writing manager at Worldwide Clinical Trials, Stephen writes and reviews a broad range of regulatory documents, including informed consent materials, covering a variety of indications and trial phases.

DDF2b Writing an investigators Brochure

  • Learn what the ICH and regulatory guidelines say about the Investigator’s Brochure (IB)
  • Learn useful tools and advice for the actual writing, compiling, and managing of an IB project
  • Experience the dynamics of team writing and editing as it pertains to an IB.
Participant profile: Medical writers with at least 1 year of experience in the pharmaceutical industry.
Shreya Bhargava
Shreya accidentally discovered the field of Medical Writing after completing her Masters in Biotechnology. What began as a curious experiment flourished into passion, and there has been no looking back. Shreya has been crafting medical writing documents for the past 12 years and has worked on a variety of clinical regulatory and pharmacovigilance documents across therapeutic areas and development phases.

Shreya has worked across diverse ecosystems, including business service providers, a contract research organization, and big pharma, and brings with her a repertoire of experience and insight in the world of medical writing.

Shreya has been a presenter at the DIA India Conference (2017), presenter and member of the scientific committee for the annual conference held by the Indian Society for Clinical Research (2019), and an EMWA Workshop Leader (since 2024).

NEW DDF55 Converting an Investigational New Drug (IND) application into an Investigational Medicinal Product Dossier (IMPD): process, regulatory requirements and potential pitfalls

Participants of this workshop will get familiar with the differences and similarities between the IND and IMPD and will be equipped for preparing a full IMPD document using IND as a source and starting point.
Participation profile: This course is intended for medical writers with some experience in regulatory writing and already familiar with the drug development process.
Pavle Simeunovic

Pavle is an experienced medical writer in Worldwide Clinical Trials, specializing in the preparation and quality control of clinical study documents, including protocols, CSRs, and IMPDs. He comes from a background in pharmacy, and with over seven years in the industry Pavle ensures IMPD compliance with regulatory requirements and plays a key role in document coordination.

PTF22 Managing the Clinical Study Protocol Writing Process

The objective of this workshop is to present the process of study protocol preparation to medical writers as a type of project management. The emphasis will be on the process of how the medical writer can effectively lead the preparation, review, and finalization of a clinical study protocol as a member of a multifunctional team. Study protocol writing will not be discussed in detail.Upon completion of this workshop, participants should be better prepared to work efficiently within a complex and at times quickly changing environment.
Participant profile: This workshop is aimed at company staff and freelance medical writers who are interested in learning how they can make an effective contribution to the protocol writing process by taking a leading role. Previous participation in the workshop on The Clinical Study Protocol is recommended.
Abe Shevack

Abe F. Shevack MA, ELS is a Biologist with many years of experience in basic research in both academia and industry. He is also a certified Editor in the Life Sciences. For over 20 years as a senior scientific medical writer at Schering and Bayer, Abe wrote numerous regulatory documents including clinical study protocols, investigator’s brochures, study reports, and common technical documents (CTD) for global regulatory submissions. He has worked in a wide range of therapeutic indications and has participated in successful global marketing authorisations for new drugs in leukaemia, non-Hodgkin’s lymphoma, hepatic cell carcinoma, macular degeneration, and men’s health. Since 2016, Abe has been the owner of Associated Medical Writer Services where he writes and consults for clients in pharma and biotech. He has been a member of EMWA since 1996 and is a past-President (2017-2018) and workshop leader. He is currently the chair of the EMWA Ambassador’s Programme.

MDA1 Literature Reviews for Medical Devices

The aim of this workshop is to understand how to write a literature review as part of a clinical evaluation report (CER). Participants will learn how to prepare a literature review to Medical Device Regulation (MDR) requirements.
Participant profile: This workshop is intended for medical writers who are either interested in working with medical devices or who already work with medical devices and are involved in preparing literature reviews for CERs. Familiarity with European medical device regulations and the CER writing guideline MEDDEV 2.7/1 rev. 4 is desirable. Prior attendance at the Introduction to Writing for Medical Devices workshop would be helpful but is not essential.
Gillian Pritchard

Gillian Pritchard (Director, Sylexis Limited, UK) is a regulatory medical writer specialising in writing clinical evaluation reports and literature reviews for medical devices. She has worked on medical devices for orthopaedic, cardiology, ophthalmology, gynaecology, wound closure, diabetes and weight loss indications. Gillian trained as a physician and has many years’ experience as a research physician in academia and phase I-II contract research; as a clinical project manager of phase III trials with Pfizer GRD; and with a pharmaceutical and medical devices consultancy. In 2006 Gillian established Sylexis Ltd. to provide regulatory writing services for pharmaceutical and medical device clients. Gillian gives workshops on literature reviews and clinical evaluation reports.

MSF7 Fundamentals of Immunology

The purpose of this workshop is to introduce medical writers (irrespective of their area of specialisation or the nature of documents they work on) to the basic principles of immunology. The ultimate aim of the workshop is to enable medical writers to better understand fundamental immunological concepts which in turn helps to better interpret the meaning of the results of clinical trials.
Participant profile: This workshop is intended for medical writers with little or no background in immunology or those who are interested in refreshing their knowledge on the basic principles of immunology
Uma Swaminathan

Uma’s passion for medical writing brought her all the way from Bangalore (India) to Belgium. During her Scientific Writing career of over 7 years at GSK, Uma has worked on a wide range of regulatory and disclosure documents across different vaccine projects. Following her stint in Medical Writing, Uma headed the Web Disclosure Team in GSK Biologicals which allowed her to further develop her skills in the field of project management, medical governance and scientific communication.  These included such diverse activities as understanding and complying with the complex and ever-changing legal and regulatory requirements for disclosure; planning, tracking and delivery of protocol and results summaries; cross-functional training; and increasing the public disclosure awareness within the company. Uma then set up the Clinical Process Excellence Team in GSK Biologicals with oversight for process and written standards simplification in the human subject research space across all Clinical Delivery functions and transversally for the activities directly impacting clinical trials. Uma then moved to GSK Pharmaceuticals to head the Clinical Development Policy and Process group that drives consistency, accountability and continuous improvement in the way clinical development processes are governed, created, documented and continuously improved. Uma’s assignment as Ethics & Compliance Director in Vaccines focused on enabling value-based decision making and smart risk taking while maintaining quality and compliance. In her current role as Head of R&D Bioethics & Policy, Uma and her team support the Chief Medical Officer in establishing patient focused and pragmatic R&D Policies.

PTA8 Statistical Analysis of Binary Data

To gain familiarity with some of the techniques used for analysing binary data and the various measures of association, such as odds ratios or relative risks, used in analysing binary data.
Participant profile: Medical writers who wish to understand the analyses of binary data (i.e. yes/no outcomes such as death, response to treatment etc.). Participants should be familiar with basic statistical concepts such as P-values and confidence intervals.
Adam Jacobs

After getting bored of his first two careers (organic chemistry research and medical translating), Adam worked as a medical writer, first at a small contract research organisation and then at a large medical communications agency. He set up his own business in 1999, which was a lot of fun for a while but sadly didn’t survive the recession and ceased trading in 2014. Adam was EMWA President in 2004–2005 and was co-author of EMWA’s guidelines on the role of professional medical writers in publications. He finally got bored of medical writing as well, and now works as a statistician. However, he doubts he will ever get bored of coming to EMWA conferences.

DDA33 Estimands: A 360-degree approach for medical writers

The workshop is designed to facilitate interpretation of the International Council for Harmonisation (ICH) guideline E9(R1) 2019, which drives estimand development into trial design, and to clarify the MW’s role and responsibilities in relation to that of medical experts and statisticians in ensuring that estimands are considered as part of a proactive cross-functional approach to writing the CSP. At the end of the workshop, attendees should understand the concept of estimands and their impact on CSPs and other study-level documents, and have acquired the knowledge and skills to author or review CSPs that include estimands.
Participant profile: The workshop is for MWs working in the CRO or pharma environment, who have written at least one or reviewed several clinical study protocols (CSPs). Managers of MW groups will also benefit from understanding estimand-driven processes that impact business and wider operational considerations.
Alison McIntosh

Alison has been a medical writer for the pharmaceutical industry for almost 30 years, and has written extensively for regulatory authorities, and other audiences. She became a medical writer after completing her PhD and a further 5 years of postdoctoral research in molecular virology. Her wealth of experience encompasses many different types of documents including manuscripts, book chapters, and clinical and scientific abstracts, as well as clinical study reports, investigator brochures and other regulatory documents. Alison has been a workshop leader since 2001 and is a section editor for the EMWA journal Medical Writing. She currently serves as a committee member of the EMWA CORE Reference Project.

Sam Hamilton

Sam Hamilton is a postdoctoral virologist, with 32 years in clinical and regulatory medical writing and leadership roles in the pharmaceutical industry. Sam has a special interest in public disclosure of clinical-regulatory documents as Chair of the EMWA-AMWA group who delivered the open-access www.core-reference.org in May 2016. Sam is long-time supporter of EMWA serving in various roles over 19 years, notably as Freelance Advocate; Editorial Board member for Medical Writing (MEW); Workshop Leader; Expert Seminar Series (ESS) Chair; and Vice President and President. Sam was elected an EMWA Nick Thompson Fellow in 2018 for her services to the Association. Sam is currently MEW Section Editor for the “Regulatory Public Disclosure” Section, and Chair of The CORE Reference Project.

DDA24b Clinical Study Reports in Oncology

This workshop aims to provide a systematic overview of what is different about oncology CSRs. Having attended the workshop, Medical Writers should have an understanding of key oncology concepts and should be able to apply these to the writing of the different report sections.
Participant profile: This workshop is intended for medical writers who have already some experience in the writing of clinical study reports (CSRs) but no experience in oncology. Participants should have a general understanding of clinical study designs, of the guidance provided by ICH E3, and should be familiar with basic clinical trial statistics.
Thomas Schindler
Thomas M Schindler studied biology and linguistics in Germany and the UK, obtained a PhD in molecular physiology, and did postdoctoral research in the UK. Thereafter, he became an editor of popular science books in biology, geography, and astronomy. He then turned to medical writing and has now gained some 25 years of experience in both medical affairs and regulatory medical writing including the preparation of all documents for marketing authorization applications around the globe. He founded and established the medical writing function at Boehringer Ingelheim and has recently headed the Innovation Medical Writing Group focussing on lay communication, good graphics development, video creation and AI-driven writing. He is currently Director Global Regulatory Affairs – Operations at BioNTech.
He was a member of the TransCelerate Return of Results work stream, is contributing to the Good Lay Summary Practice initiative and the PFMD Plain Language Summary guidance.
Mona Wegert

Mona is a Senior Medical Writer in the Global Medical Writing Group, Therapeutic Area Oncology at Boehringer Ingelheim Pharma. She has more than 10 years of experience in writing and managing regulatory documents along the drug lifecycle. She has worked in several therapeutic areas, however, her focus has been on oncology most of the time. Over the years, Mona has introduced many new colleagues to the ins and outs of regulatory document writing. Mona holds a degree in Human Biology and she completed her PhD in the field of immunology.

PTF28 PowerPoint for medical writers

The objective of the workshop is to give an overview of some of the functions of Microsoft PowerPoint, beginning from the very basics, and provide a practical guide to their use. There will be several hands-on exercises during the workshop for which a laptop with PowerPoint installed would be very helpful, although is not essential.
Participant profile: This workshop is aimed at medical writers looking to begin using Microsoft PowerPoint, or to refresh their basic skills.
Helen Chambers
Helen is the Medical Communications Director at Costello Medical Consulting, overseeing the company’s Publications, Medical Affairs and Creative service offerings across the UK, North America and Asia. Her focus is on ensuring that the team and the work they deliver is at the forefront of the latest industry developments, such as the development of digital content, patient engagement and AI.
Helen holds the Certified Medical Publication Professional™ (CMPP™) credential from the International Society for Medical Publications Professionals (ISMPP), an Advanced Certificate in Medical Writing from EMWA, and serves as a member of the EMWA Professional Development Committee and the ISMPP Publications Ethics & Standards Committee. She also delivers guest lectures on the University of Cambridge Therapeutic Sciences MPhil course on Medical Communication.

Colour Guide

  • EPDP/EDG
  • AI Theme
  • Protocol Theme
  • Patient Voice Theme
  • Free sessions
  • Social events
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