EMWA Webinars Programme

Carolina is a Medical Writer and Scientific Communications Consultant, medically qualified and skilled at reporting complex scientific information and working with key opinion leaders to write and edit medical communications, moderate advisory boards, and deliver educational seminars online and in-person.

She is adept at keeping abreast of current literature, emerging sciences, technological developments and medical trends, and exploiting her medical education and high adaptability on therapeutic areas to write and deliver high-quality medical documents.

Additionally, she is passionate about Sustainable Nutrition, i.e. predominantly plant-based nutrition patterns, and has created and delivered education to encourage dialogue among clinicians and scientists about nutrition.

We are happy to announce upcoming webinars below. Webinars may be either recorded and uploaded on the due date or live online seminars. For live webinars, you only need to register and then connect to our webinars platform on the due date. A recording will be available shortly after the event in the Archive section. Nevertheless, we advise you to participate, because this will enable you to ask questions and contribute to an active discussion. For the recorded webinars we encourage you to send us any questions you may have on the topic by the date indicated and they will be answered in the recording.

Please email the webinar team with any questions or accessibility concerns.

Note: We reserve the right to cancel a webinar if needed, although we will make all effort to avoid it. Also, we make every effort to ensure we have a stable internet connection to run EMWA webinars, but it is not possible to provide a 100% stable connection. If for any reason, the presentation has to be cancelled by the organiser, a notification email will be sent as soon as possible.

2023 WEBINARS:

Thursday, 16th February 2023, 14:00 CET

Fact-checking: what medical writers can learn from journalists
by Sampoorna Rappaz, PhD, Freelance medical writer and editor and Adeline Rosenberg, MSc, Senior medical writer, Oxford PharmaGenesis Ltd

We, as medical communicators, must ensure that all the hard facts and implied meanings in our deliverables are presented clearly, accurately, and precisely. Fact-checking, therefore, is an integral part of trustworthy communication. The practice is simple but not easy. Medical communicators can learn a lot from the journalistic practice of fact-checking. In this webinar we will cover the interesting history of fact-checking, the basic fact-checking process, how fact-checking is done in science journalism, checklists that can improve the efficiency of the process, expert tips from science journalists, and finally, how we can apply these learnings to medical journalism. Living in a post-truth world means getting your facts right!

This webinar can now be accessed here.

---

Wednesday, 8th March 2023, 16:00 CET

Good Publication Practice 2022: Focus on Medical Writing

by Lisa M DeTora, PhD, MS, Fiona J. Plunkett, PhD, and Zoe Preston, MPhil

This special seminar will focus on the development of GPP 2022 and the role of publications professionals in that process. You will be able to understand the portions of GPP 2022 that focus on the medical writing role and how to use it as a training tool. In this session, you are encouraged to bring your questions and comments about the GPP 2022, as we will have an extended Q&A after the presentation.

This webinar can now be accessed here.

---

Thursday, 30th March 2023, 13:00 CET

Next Generation Protocols - where are we going?

by Jonathan Mackinnon, PhD

The clinical research industry is going through a bit of a makeover and changes to clinical study protocols are coming from every direction. Whether it's ICH E8(R1), ICH M11, EU-CTR, decentralized clinical trials, complex designs or diversity, equity & inclusion; study teams are under increasing pressure to address new - and unfamiliar - requirements. What does this mean for regulatory medical writers? Study teams are turning to us and asking the same thing - what do we need to include in our protocol? This webinar provides an introduction of current challenges facing protocol development as well as key resources for further reading.

This webinar can now be accessed here.

---

Wednesday, 12th April, 2023, 16:00 CET

Ethical Issues in Clinical Trials

by Art Gertel, Principal, MedSciCom, LLC

This webinar will provide an opportunity to explore various ethical considerations associated
with clinical research and healthcare-related social justice. The format will be a conversation
between an “interlocutor” and Art Gertel, our resident bioethicist. Questions will initiate an
extemporaneous give-&-take.
Topics might include:

• The evolution of patient protections – how did we get here?
• Individual vs. society: is there a social contract?
• Do desperate circumstances warrant desperate measures?
• Is there such a thing as “one size fits all”?

This webinar can now be accessed here.

---

Thursday, 29th June, 2023 at 16:00 CET

An Ideal Medical Writing Team requires a continuous learning and development environment

by Dr. Namrata Singh, Founder and Director of the Turacoz Group

Dreaming of having an ideal medical writing team is only possible if we have an integrated learning and development system as a backbone in any company. Starting from newbies or professionals with limited experience to experienced medical writers who have worked in different companies, the transfer and sharing of knowledge and real life experience is what makes the difference. The webinar will talk about the levels of training that are essential to nurture new medical writers and adapt experienced writers to the changing times of technology and large language models like OpenAI etc.

1. External training program where the target are university graduates/postgraduates and newbies looking to enter the industry.
2. Induction training program to align the new medical writers (with different levels of experience) to the work processes in the company and training on mandatory skills
3. Continuous skill development on a half yearly basis to align with the career growth and where do the writers want to reach- is a customized program which is based on the writer’s interest and the requirements in the company (wrt upcoming projects or business projections)
   
   

Further details to be announced shortly. 

---

July 2023

Shedding some light on classification rules for Medical Device Software
by Katharina Friedrich, Dr. med. (MD)

The Medical Devices Regulation introduced a new classification rule especially for Medical Devices Software. Rule 11 provides information about the consequences for Medical Device Software which is used to make decisions for diagnostic or therapeutic purposes. Depending on the potential impact on a patient's state of health, the software can be classified as IIa, IIb, or even III when the decision might result in death or irreversible deterioration of health. In contrast to the Medical Devices Directive, it has become very difficult for stand-alone software to be classified as class I. But what software can remain class I? And what are the consequences of stricter classification rules? With the help of MDCG 2019-11 – the guidance on qualification and classification of software – this webinar will shed some light on classification rules for Medical Devices Software and will explain the challenges and consequences with practical examples.

Further details to be announced shortly. 

---

September, 2023

Pharmacovigilance Webinar: Reporting of Adverse Events 

by John Praveen

John Praveen is the Associate Vice President – PV Account Delivery and PV Shared Services Offering Lead at Accenture. He has more than 14 years of experience working with 10+ clients across geographics in PV Project Management and Service Delivery (across Pharmacovigilance, Medical Devices Vigilance, Cosmetovigilance and Nutraceutical Vigilance). He also leads and manages the Business Process Transformation (including technology enabled i.e macros, RPA, AI and Analytics), E2E Project Transitions, Training and Capability Development and supports with PV Business Development including pre-sales and end to end bid management.

John completed his Bachelors and Master’s Degree in Biological Science and Microbiology & Immunology from St Joseph’s University, Bangalore and PG Diploma in Medical Entomology and Medical Genetics from St Joseph’s University in Bangalore. He also has a management degree from Indian Institute of Management, Lucknow. He is also an Accenture certified Business Advisory Expert.

This webinar will focus on the following topics:

• History of Pharmacovigilance
• Need for Pharmacovigilance
• Basics of PV
• ICSR and Classifications
• Seriousness & Expectedness & Causality Assessment
• Reporting Requirement
• Aggregate Report
• Signal Detection and Safety Surveillance

Further details to be announced shortly.

SEE PAST WEBINARS

View Past Webinars

(Member login required)

VOLUNTEERING FOR EMWA WEBINARS

If you think you have something interesting to communicate to other EMWA members and are eager to run a webinar of your own, contact the webinar team. Your proposal will be evaluated by the webinars team and the EPDC and we will provide our feedback as soon as possible.