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BEGIN:VEVENT
DTSTART;TZID=Europe/Belgrade:20251014T130000
DTEND;TZID=Europe/Belgrade:20251014T140000
DTSTAMP:20260725T230905
CREATED:20250829T124744Z
LAST-MODIFIED:20250829T124744Z
UID:10000009-1760446800-1760450400@emwa.org
SUMMARY:Upgrading your protocol writing skillset: best practice insights for protocol development 
DESCRIPTION:October 14th\, 13.00 CET \nJonathan Mackinnon\n\nThe skillset of medical writers is constantly evolving. Influences from patient centricity\, trial complexity\, technology\, and project management mean that we’re now expected to bring more skills than ever before to our daily work. We are no longer “only” expected to author the protocol by capturing the decisions of a small team of contributors\, rather incorporate multiple fragmented information streams\, balance complexity with clarity\, understand and implement technology\, and manage increasingly complex team structures.\nThe webinar will provide an overview of the current best practice techniques used by a global medical writing team to handle these new and growing challenges. The learning objective of the webinar is to provide guidance and methodology to help medical writers approach contemporary protocol development.\n\nLevel: Intermediate/advanced\n\nPrevious knowledge required: General protocol structures/content\, familiarity with developing protocols or regulatory documents\, ICH E6(R3)\, ICH E8(R1).\n \nTo register\, please click here
URL:https://emwa.org/event/upgrading-your-protocol-writing-skillset-best-practice-insights-for-protocol-development/
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Madrid:20251112T150000
DTEND;TZID=Europe/Madrid:20251112T170000
DTSTAMP:20260725T230905
CREATED:20250723T091548Z
LAST-MODIFIED:20251022T071115Z
UID:10000006-1762959600-1762966800@emwa.org
SUMMARY:Getting into Medical Writing Virtual Session
DESCRIPTION:Virtual only \nREGISTER HERE \nGetting into Medical Writing Virtual Session \nWednesday 12th November 2025\, 3-5 pm CET \nThe GIMW Organising Committee is pleased to offer another virtual Getting into Medical Writing session. In this free\, 2-hour session\, experienced medical writers and EMWA members will present and discuss their transition stories into medical writing\, what a day in their job looks like\, useful skills\, training opportunities\, networking strategies\, and more. \nAspiring/new medical writers will have the chance to ask questions and network with other professionals in the field. This session is fully virtual and open to non-members of EMWA from all over the world. \nThe session will include: \n\nTransition into medical writing\nDifferent types of medical writing\nFreelancing vs. employment\nTransferable skills\nTraining opportunities\nQ&A and networking opportunities\n\nWe invite you to join us and to spread the word among those who might be interested. \nAgenda \n\nFrom academia to regulatory writer (Matthew Edmonds)\nFreelance medical writing as a thriving business (Sofia Urner)\nChanging from patient-facing clinical work to medical writing (Fiona Beck)\nFrom academia to scientific leadership (Francesca Cappellini)\nStepping into Leadership: From Medical Writer to Manager (Sarah Hopwood)\nHow I created my dream job (Evguenia Alechine)\nQ&A and online networking (in breakout rooms; 3 rounds; 6 rooms)\nIn and around EMWA and the upcoming virtual conference (Abe Schevack)\n\nREGISTER HERE
URL:https://emwa.org/event/getting-into-medical-writing-virtual-session/
CATEGORIES:Webinar
ATTACH;FMTTYPE=image/png:https://emwa.org/wp-content/uploads/2025/07/GIMW-12Nov2025.png
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/London:20251114T080000
DTEND;TZID=Europe/London:20251129T170000
DTSTAMP:20260725T230905
CREATED:20250527T132933Z
LAST-MODIFIED:20251031T141104Z
UID:10000002-1763107200-1764435600@emwa.org
SUMMARY:EMWA 60th virtual conference
DESCRIPTION:
URL:https://emwa.org/event/emwa-60th-virtual-conference/
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Amsterdam:20251210T160000
DTEND;TZID=Europe/Amsterdam:20251210T170000
DTSTAMP:20260725T230905
CREATED:20251031T160059Z
LAST-MODIFIED:20251031T160059Z
UID:10000011-1765382400-1765386000@emwa.org
SUMMARY:Visual Comms SIG Meet & Share – Visual Storytelling to Communicate Medical Science to Children
DESCRIPTION:Visuals improve comprehension by capturing a story and translating it into a big picture. Especially in medical communication\, which is full of technical terms and complex language\, health information can become difficult to digest and overwhelming. In this Meet & Share\, Janaine will discuss how to use images and/or graphs to explain a medical condition. Importantly\, she will also explore how to use creativity and simple associations to turn medical and scientific knowledge into fun visual storytelling\, including: \n· Use everyday objects and turn them into illustrations to explain medical conditions\, for example\, using the peel of an orange to explain the meninges in meningitis. \n· Inclusion of fairy tales\, where a princess might become sick from an allergy\, and her journey can help children understand symptoms and treatments. \nTo register click the button below \n register
URL:https://emwa.org/event/visual-comms-sig-meet-share-visual-storytelling-to-communicate-medical-science-to-children/
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Bratislava:20251211T130000
DTEND;TZID=Europe/Bratislava:20251211T140000
DTSTAMP:20260725T230905
CREATED:20251119T163614Z
LAST-MODIFIED:20251124T084245Z
UID:10000012-1765458000-1765461600@emwa.org
SUMMARY:Diversity and inclusion in clinical trials
DESCRIPTION:December 11th\, 13.00 CET \nDiversity and inclusion in clinical trials \nDarius-Jean Namdjou\, PhD \nUnderrepresentation of certain groups\, e.g. via gender\, ethnicity\, socioeconomic status and further parameters\, is affecting clinical trials\, particularly in late-stage development trials. The resulting inequalities in access to clinical trials have led\, as current research indicates\, to consequential issues concerning e.g. efficacy and/or safety of authority-approved medicines in these underrepresented populations. In agreement with the overall goal of a more patient-centric drug development\, the topic of inclusion to clinical development has been recently addressed by EMA in its Draft Reflection Paper on Patient Experience Data (PED)\, while US FDA’s thinking on diversity has been described in guidance documents on Diversity Action Plans for pivotal clinical trials. Holistically on a global scale\, both topics were addressed in the WHO guidance document on best practices for clinical trials. The scope of this presentation is to inform about current efforts to foster equality in access to clinical trials and to make the webinar participants aware of the corresponding developments affecting future global drug development. \nLearning objective: \nReceive the necessary knowledge on inclusion\, diversity and strengthening the patient voice in clinical development to start raising awareness\, including triggering thinking processes on respective practical implementation \nLevel: Intermediate \nTo register\, please click here
URL:https://emwa.org/event/diversity-and-inclusion-in-clinical-trials/
CATEGORIES:Webinar
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Paris:20260114T180000
DTEND;TZID=Europe/Paris:20260114T190000
DTSTAMP:20260725T230905
CREATED:20251126T153432Z
LAST-MODIFIED:20251126T153432Z
UID:10000013-1768413600-1768417200@emwa.org
SUMMARY:Sustainability SIG – Meet & Share
DESCRIPTION:Since the COVID pandemic\, the relevance of the One Health approach to understand and address the complex health and planetary issues we face is receiving greater recognition. At the global and EU level\, there are calls to inform\, integrate\, and coordinate cross-sector policies and actions based on One Health concepts. The SUS-SIG welcomes all EMWA members to come join a special Meet & Share session entitled\, “One Health is over 20 years old. What is next?” on Wednesday\, January 14\, 2026 from 18:00-19:00 hr (CET). This session will be led by One Health and EcoHealth consultant Craig Stephen\, DVM PhD FCAHS. Come join us and share your questions and experience with the One Health approach! \nAbstract \nThe phrase “One World – One Health” was coined and trademarked in 2004. Since then\, One Health has found its way into numerous proclamations\, agreements and policies at the multilateral\, regional\, national and local level. At no time in recent history\, have so many agencies and governments been mentioning the interconnections of human\, animal and environmental health. But as more and more organizations use the term for an ever-widening scope of activity\, can One Health deliver? One Health is neither new nor unique. Several similar concepts are as old as time or have blossomed then faded over the last 5 decades. This talk will explore the gap between One Health’s good intentions and the reality of its application. It will propose some key opportunities and obstacles that need to be addressed to achieve the ideal of interspecies and intergenerational health equity and address the increasing acuteness and number of planetary emergencies. This talk will draw on Craig Stephen’s over 30 years experience working in this milieu. \nSpeaker Biography \nCraig Stephen DVM PhD FCAHS has devoted his career to developing ideas\, people\, policies and evidence to concurrently promote the health of people and animals and their shared environments. He uses population health and health promotion concepts on a wide set of issues ranging from conservation\, to climate change\, to emerging diseases. This work has been recognized through his election as Fellow of the Canadian Academy of Health Sciences. As a One Health and EcoHealth consultant\, Craig works globally with all levels of government\, the non-profit sector\, community groups\, universities and industry to examine complex health issues at the nexus of people\, animals and environments. His aim is to help develop sensible\, practical and evidence-based policies that promote an inter-species and inter-generational approach to health. Craig is a veterinarian and epidemiologist. He currently leads the McEachran Institute\, which is a Canadian charity dedicated to provoking disruptive thinking and forging collaborative solutions that protect animals\, health\, and society in a rapidly changing future. \nTo register click here
URL:https://emwa.org/event/sustainability-sig-meet-share/
CATEGORIES:Meet & Share
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Belgrade:20260116T123000
DTEND;TZID=Europe/Belgrade:20260116T133000
DTSTAMP:20260725T230905
CREATED:20251201T142757Z
LAST-MODIFIED:20251201T142757Z
UID:10000014-1768566600-1768570200@emwa.org
SUMMARY:CORE Reference Project webinar
DESCRIPTION:The next CORE Reference Project webinar is scheduled for Friday 16 January 2026 (12.30-13.30 CET/11.30-12.30 UK time). \n External speaker Mirjana Miric from Worldwide Clinical Trials will present a webinar on the topic “CTIS and Clinical Trial Transparency: Strategies\, Challenges\, and CRO Insights.” The upcoming webinar will focus on the protection of personal data and commercially confidential information in clinical trial information submitted to Clinical Trials Information System. \nRegister here
URL:https://emwa.org/event/core-reference-project-webinar/
CATEGORIES:Webinar
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Madrid:20260127T130000
DTEND;TZID=Europe/Madrid:20260127T140000
DTSTAMP:20260725T230905
CREATED:20260107T164331Z
LAST-MODIFIED:20260113T155528Z
UID:10000015-1769518800-1769522400@emwa.org
SUMMARY:Briefing Books Webinar
DESCRIPTION:January 27th\, 13.00 CET \nFrom Questions to Clarity: Crafting Effective Briefing Books \nAnja Ramsay\, PhD \nThis webinar explores briefing books as strategic tools for regulatory interactions with agencies such as EMA and FDA. These documents inform agencies about development programs and frame questions requiring guidance\, serving as a foundation for scientific dialogue rather than simple summaries. EMA emphasizes written scientific advice and mandatory templates\, allowing flexible timing\, while FDA relies on formal meetings (Type A\, B\, C) with structured timelines and no strict template. Essential components include background\, development overview\, questions with rationale\, and supporting data. Strategic writing principles—clarity\, consistency\, and alignment with development goals—are critical\, alongside tailoring content to agency expectations and anticipating regulatory concerns. The webinar also addresses challenges such as limited training on briefing books and highlights global practices for other agencies\, underscoring the vital role of medical writers in ensuring compliance and facilitating successful regulatory outcomes. \nTakeaway messages: \n· Takeaway message #1: Briefing books are strategic tools\, not summaries; they enable structured dialogue with regulatory agencies to inform them about development plans and frame precise questions for guidance. \n· Takeaway message #2: Be aware of the main differences: EMA provides written scientific advice\, has a mandatory template with flexible timing. FDA holds formal meetings (Type A\, B\, C)\, has no strict template\, but follows structured timelines. \n· Takeaway message #3: Well-prepared briefing books reduce regulatory risk\, streamline interactions\, and support efficient drug development. Strategic writing is critical to ensure clarity\, consistency\, and alignment with development goals. \nLevel: Foundation/Intermediate \nPrevious knowledge required: To fully benefit from the webinar\, the following background knowledge is recommended: \n· Basic Regulatory Framework: Familiarity with drug development stages (preclinical\, clinical phases) and regulatory submissions like IND\, NDA\, and MAA. \n· Regulatory Agencies: Awareness of major agencies such as EMA and FDA\, and their roles in approving medicines. \n· Medical Writing Fundamentals: Understanding of structured documents\, clarity principles\, and compliance with guidelines. \n· Clinical Development Concepts: Knowledge of study design\, endpoints\, comparators\, and terminology (e.g.\, orphan drugs\, CHMP\, SAWP). \nRegister here
URL:https://emwa.org/event/briefing-books-webinar/
CATEGORIES:Webinar
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Madrid:20260130T130000
DTEND;TZID=Europe/Madrid:20260130T140000
DTSTAMP:20260725T230905
CREATED:20260108T103245Z
LAST-MODIFIED:20260108T103245Z
UID:10000016-1769778000-1769781600@emwa.org
SUMMARY:EMWA Q&A event on publications writing
DESCRIPTION:13.00 CET \nA live Q&A Event \nWhether you are just starting out\, interested in transferring to publications writing\, or currently waist-deep in a challenging manuscript\, we hope to answer your questions\, provide tips\, and share our enthusiasm for publications medical writing. \nExperienced medical writers Barbara Bartolini\, Fiona Beck\, and Alexander Lowe will be in the hotseats. The session will be moderated by Evguenia Alechine. \nRegister Here
URL:https://emwa.org/event/emwa-qa-event-on-publications-writing/
CATEGORIES:Q&A
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/London:20260305T130000
DTEND;TZID=Europe/London:20260305T140000
DTSTAMP:20260725T230905
CREATED:20260202T165412Z
LAST-MODIFIED:20260212T131543Z
UID:10000018-1772715600-1772719200@emwa.org
SUMMARY:Clinical Evaluation Under MDR and IVDR: Practical Updates and Implementation Strategies for Medical Writers
DESCRIPTION:Clinical Evaluation Under MDR and IVDR: Practical Updates and Implementation Strategies for Medical Writers \n  \nHatem Rabeh\, MD\, MSc \n  \nThe recent updates to the MDR and IVDR frameworks have introduced important changes that directly impact how clinical evidence is planned\, documented\, and reviewed. For medical writers and regulatory professionals\, translating these regulatory updates into operational workflows remains challenging. \nThis webinar will provide a practical overview of the latest regulatory updates affecting clinical evaluation and performance evaluation. It will focus on how these changes influence clinical evaluation plans\, clinical evaluation reports\, post market clinical follow up activities\, and evidence lifecycle management. \nThrough real case examples and field experience\, participants will learn how to adapt documentation strategies\, align evidence generation with regulatory expectations\, and avoid common compliance pitfalls. The session is designed to support professionals involved in regulatory writing\, clinical documentation\, and evidence planning for medical devices and IVDs under the European regulatory framework. \n  \nKey takeaways for participants \n  \n\nUnderstand the main MDR and IVDR updates impacting clinical and performance evaluation activities\nLearn how to translate regulatory requirements into practical documentation workflows\nIdentify frequent compliance gaps observed during Notified Body reviews and how to prevent them\n\n  \nLevel: Intermediate/Advanced \n  \nTo register\, please click here \nRegister here
URL:https://emwa.org/event/clinical-evaluation-under-mdr-and-ivdr-practical-updates-and-implementation-strategies-for-medical-writers/
CATEGORIES:Webinar
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Belgrade:20260320T130000
DTEND;TZID=Europe/Belgrade:20260320T160000
DTSTAMP:20260725T230905
CREATED:20260309T173135Z
LAST-MODIFIED:20260309T173421Z
UID:10000021-1774011600-1774022400@emwa.org
SUMMARY:Getting Into Medical Writing
DESCRIPTION:13:00 – 16:00 CET \nThe GIMW group is pleased to offer another virtual Getting into Medical Writing session. In this 3-hour session\, experienced medical writers and EMWA members will present and discuss the vast scope of the medical writing profession and how EMWA can help you achieve your professional goals in this rewarding career path. \nAspiring/new medical writers will have the chance to hear first-hand the stories of successful medical writers and network with other professionals in the field. This session is fully virtual and open to non-EMWA members worldwide. \nThe session will cover: \n\nAn introduction to medical writing\nTypes of medical writing: Regulatory vs. MedComms\nFreelancing\nTransferable skills from academia\nAdvisory boards\nRecruiting process\nCVs & LinkedIn\nNavigating EMWA and its offerings\nThe upcoming conference in Barcelona\, May 2026\nQ&A and networking opportunities\n\nWe invite you to join us and to spread the word among those who might be interested. \nRegister here
URL:https://emwa.org/event/getting-into-medical-writing/
CATEGORIES:Webinar
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Madrid:20260325T130000
DTEND;TZID=Europe/Madrid:20260325T140000
DTSTAMP:20260725T230905
CREATED:20260128T102111Z
LAST-MODIFIED:20260202T165213Z
UID:10000017-1774443600-1774447200@emwa.org
SUMMARY:Responding Effectively to Health Authority Questions
DESCRIPTION:March 25th\, 13.00 CET \n  \nResponding Effectively to Health Authority Questions \n  \nBhawna Basin\, Christina Eichhorn \n  \nEffective responses to health authority questions are critical to the success of marketing applications such as Biologics License Applications (BLAs)\, Marketing Authorization Applications (MAAs)\, New Drug Applications (NDAs)\, and other global submissions as they represent the final steps before health authorities determine a product’s overall benefit-risk profile. These interactions offer opportunities to build trust with regulators\, demonstrate scientific integrity\, and showcase a team’s responsiveness. This webinar offers a clear\, practical overview of what health authority questions are\, why agencies issue them\, and how to navigate major versus minor queries. Participants will learn strategies for interpreting regulatory intent\, crafting clear and scientifically sound responses\, and applying best practices in communication tone\, structure\, and collaboration. Best practices for cross‑functional collaboration\, evidence presentation\, and managing timelines will also be discussed. This webinar is ideal for medical writers involved in global regulatory submissions. \n  \nTakeaway messages: \n\nUnderstand what health authority questions are and why health authorities issue them during the review of BLAs\, MAAs\, NDAs\, and other global submissions.\nAccurately interpret regulatory intent and present evidence effectively\, ensuring data are well‑organized\, supported\, and easy for reviewers to follow.\nCollaborate efficiently across functions to gather data\, align on messaging\, and develop cohesive responses under tight deadlines.\n\n  \nLevel: Foundation/intermediate \n  \nPrevious knowledge required: The following background knowledge is recommended: \n  \n\nExperience in preparing regulatory submissions like NDA\, BLA\, and MAA.\nProficient in the structure and requirements of Common Technical Document (CTD)‑formatted submissions.\nRegulatory knowledge about major health authorities such as EMA and FDA.\n\n  \n  \nTo register\, please click here \nRegister here
URL:https://emwa.org/event/responding-effectively-to-health-authority-questions/
CATEGORIES:Webinar
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/London:20260427T170000
DTEND;TZID=Europe/London:20260427T180000
DTSTAMP:20260725T230905
CREATED:20260205T101955Z
LAST-MODIFIED:20260205T101955Z
UID:10000020-1777309200-1777312800@emwa.org
SUMMARY:One Narrative\, Different Formats: Turning scientific publications into understandable and engaging content
DESCRIPTION:April 27th\, 17.00 CET \nDarío Sánchez Martin\, PhD \nAbstract: Scientific and medical writers often write for extremely qualified audiences. Doctors\, PhDs\, and other highly educated people. But these people\, atop of the knowledge pyramid\, are a small fraction of society. Knowing about other formats to write about science beyond scientific publications\, clinical trial reports\, and highly complex documents is important in a society where knowledge is ever-growing demand. This short webinar will give you basic knowledge on how to turn complex science into content for all audiences\, from scientists to the general public. To do so\, we will begin with a short overview of general writing principles\, and follow into basic psychology to understand the people you write for. With these fundamentals\, we will cover how to write for any specific audience and how to do so in different content formats\, mainly social media and blog articles. Lastly\, and if time allows\, we will shortly go through an overview of visual aids (photos\, schematics\, drawings\, tables\, illustrations\, and text formatting) in written content\, and the basics of visual storytelling. \nTakeaway messages: \n\nUnderstanding your audience and their mindset is the first and most important step to communicate appropriately towards them.\nDifferent formats require different communication strategies\, mainly for opt-in vs forced readers.\nBlogs and social media content allow communications of complex concepts without loss of context if done well.\n\nLevel: foundation \nPrevious knowledge required: Basic knowledge of scientific publications and/or communications aimed at experts (doctors\, scientists)\, and different types of content\, basically LinkedIn/social media and blogs. \nTo register\, please click here \nRegister Here
URL:https://emwa.org/event/one-narrative-different-formats-turning-scientific-publications-into-understandable-and-engaging-content/
CATEGORIES:Webinar
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Ljubljana:20260429T190000
DTEND;TZID=Europe/Ljubljana:20260429T200000
DTSTAMP:20260725T230905
CREATED:20260428T145835Z
LAST-MODIFIED:20260428T150029Z
UID:10000027-1777489200-1777492800@emwa.org
SUMMARY:EMWA General Meeting of Members
DESCRIPTION:We are pleased to invite you to the EMWA General Meeting of Members (previously known as the AGM or AM)\, which is taking place on Wednesday 29th April 2026 via Zoom. 19.00-20.00 CET / 18.00-19.00 GMT\n\nPlease register your attendance: Register here\n\nThis is your chance to hear important updates from the EMWA Executive Community\, ask questions\, connect with fellow members\, and learn more about the future of our organisation.
URL:https://emwa.org/event/emwa-general-meeting-of-members/
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/London:20260505T080000
DTEND;TZID=Europe/London:20260508T170000
DTSTAMP:20260725T230905
CREATED:20250527T133043Z
LAST-MODIFIED:20250527T133143Z
UID:10000003-1777968000-1778259600@emwa.org
SUMMARY:EMWA 61st Spring Conference
DESCRIPTION:To be held in the beautiful city of Barcelona
URL:https://emwa.org/event/emwa-61st-spring-conference/
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Berlin:20260611T160000
DTEND;TZID=Europe/Berlin:20260611T170000
DTSTAMP:20260725T230905
CREATED:20260513T142134Z
LAST-MODIFIED:20260513T142956Z
UID:10000028-1781193600-1781197200@emwa.org
SUMMARY:The Role of AI in Medical Writing: Beyond Drafting Speed\, Accuracy\, QC Burden and What Actually Works
DESCRIPTION:Thursday 11th June @ 4pm CET \nSpeakers: Barry Drees\, PhD and Louise Martinsson\, PhD \nDiscussing: \n\nIs “faster drafting” solving the wrong problem? or shifting the burden into downstream QC\nLean writing vs. legacy habits- Why most documents still say more than regulators\nConsistency at scale- Why global teams struggle to produce stable\, aligned outputs\nAI in practice- Where it genuinely helps- and where it quietly introduces risk\nThe uncomfortable shift- Why regulatory writing is becoming a data and evidence problem- not a drafting exercise\n\n  \nRegister here
URL:https://emwa.org/event/the-role-of-ai-in-medical-writing-beyond-drafting-speed-accuracy-qc-burden-and-what-actually-works/
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Ljubljana:20260617T130000
DTEND;TZID=Europe/Ljubljana:20260617T135000
DTSTAMP:20260725T230905
CREATED:20260330T145654Z
LAST-MODIFIED:20260514T155737Z
UID:10000022-1781701200-1781704200@emwa.org
SUMMARY:CORE Reference Webinar
DESCRIPTION:Wednesday 17th June @ 13.00-13.50 CET \nOur next CORE Reference webinar will be presented by Marcie Roche (Argenx) who will share her insights in ICH M11\, More details to follow. Register in advance for this webinar: \nTitle: ICH M11: an integrated and forward‑looking CeSHarP perspective \nAbstract: Viewed through a regulatory medical writing lens\, ICH M11 (CeSHarP [Clinical Electronic Structured Harmonised Protocol]; adopted 19 November 2025) reframes clinical study protocols as structured\, reviewable\, and reusable source documents that preserve scientific intent and decision-making transparency. The harmonised template and technical specification reduce variability\, support interoperable electronic exchange\, and minimise unnecessary repetition through consistent content placement. \nWith the convergence of established industry approaches\, TransCelerate’s Common Protocol Template (V11\, 2026) was realigned to ICH M11\, reflecting a reconciliation of legacy authoring practices with emerging global standards that support operational efficiency and submission readiness. \nWhile CPT V11 reflects the ICH M11 protocol template and associated technical specification\, the level of detail and content implementation requires medical writing judgment beyond simple adherence to the template. \nWithin the clinical study documentation continuum\, disciplined lean authoring\, traceability\, and the critical evaluation of content for use or AI‑assisted text remain essential to ensure that protocol decisions remain aligned with downstream reporting (as reflected in the CORE Reference framework). \nThis webinar encourages medical writers and regulatory professionals to take a deliberate\, forward‑looking approach to their craft\, recognising that precise structure and clear intent are essential to scientific integrity and effective communication. \nBio: Marcie A. Roche\, PhD is a senior director of medical writing at argenx with over 20 years of pharmaceutical industry experience. She promotes the strategy and development of clinical and regulatory documents that support global health authority submissions and related agency interactions. Her work prioritises clear\, consistent\, guideline-aligned content that integrates complex concepts into lean authoring narratives\, valuing cross-functional leadership and mentoring medical writers. \n  \nRegister here \nAfter registering\, you will receive a confirmation email containing information about joining the meeting.
URL:https://emwa.org/event/core-reference-webinar-2/
CATEGORIES:Webinar
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Ljubljana:20260618T130000
DTEND;TZID=Europe/Ljubljana:20260618T140000
DTSTAMP:20260725T230905
CREATED:20260330T150243Z
LAST-MODIFIED:20260415T155137Z
UID:10000023-1781787600-1781791200@emwa.org
SUMMARY:Data Compliance for Freelance Medical Writers
DESCRIPTION:Thursday 18th June @ 13.00-14.00 CET \nVena Verga-Danemar\, J.D.\, LL.M. (Tilburg)\, LL.M.-MAS (Geneva) \nFreelance medical writers and communicators handle personal data in everyday freelance practice: in the tools they use\, the documents they produce\, and the business they run independently. Data protection obligations can arise in all three areas\, but many freelancers have only limited visibility on where those obligations sit. \nThis webinar provides a practical overview of three commonly overlooked compliance areas in independent freelance practice: the data protection implications of everyday digital tools and client agreements\, the personal data that can remain embedded in shared documents\, and the obligations that apply to the freelancer’s own business data\, separate from any client arrangement. \nKey takeaways for participants \n1. Understand the data protection implications of the digital tools used in freelance medical writing practice\, and what client agreements should address in relation to those tools.\n2. Recognise the main places where personal data can remain embedded in shared documents.\n3. Distinguish between the obligations that apply when working under a client’s instructions and those that apply to the freelancer’s own business data \nLevel: Foundation \nPrevious knowledge required: The session is grounded in real freelance workflows and assumes no prior legal knowledge. This webinar is designed for EMWA members working independently as freelance medical writers and communicators. \nTo register\, please click here \nRegister here
URL:https://emwa.org/event/data-compliance-for-freelance-medical-writers/
CATEGORIES:Webinar
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Ljubljana:20260709T130000
DTEND;TZID=Europe/Ljubljana:20260709T140000
DTSTAMP:20260725T230905
CREATED:20260330T150455Z
LAST-MODIFIED:20260415T155807Z
UID:10000024-1783602000-1783605600@emwa.org
SUMMARY:Writing for Localisation
DESCRIPTION:Thursday 9th July @13.00-14.00 CET \nAna Sofia Correia\, Medical Translator and Writer \n\nMedical and scientific content is often developed for use across multiple countries\, languages\, and audiences\, yet writing and translation are still frequently treated as separate stages. This can result in ambiguity\, terminology inconsistencies\, and cultural or regulatory mismatches that create avoidable rework and delays.\n\n\nThe webinar will explore how sourcewriting decisions directly influence translation and adaptation outcomes\, and how a localisation-aware approach can improve clarity\, consistency\, and usability from the outset. The session will cover common source-text features that make translation more difficult\, practical ways to improve localisation readiness when writing in English\, and a simple framework to support decisions on whether content should be translated\, localised\, rewritten\, or transcreated. It will also address terminology decisions and the importance of considering the broader context when content is intended for global communication. Participants will leave with practical insights to help them create source content that is clearer\, more adaptable\, and better suited for use across markets. \nKey takeaways for participants: \n\nRecognise common source-text features that make translation and adaptation more difficult.\nApply practical writing principles to create clearer\, more localisation-ready source content.\nUse a simple framework to decide when content requires translation\, localisation\, rewriting\, or transcreation.\n\nLevel: Foundation to intermediate \n\nPrevious knowledge required: None. No prior localisation or translation experience is required. The webinar will be particularly relevant for medical writers and content developers who collaborate with global teams\, affiliates\, or translation partners.\n\n\nTo register\, please click here\n\n\nRegister here
URL:https://emwa.org/event/writing-for-localisation/
CATEGORIES:Webinar
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Ljubljana:20260803T120000
DTEND;TZID=Europe/Ljubljana:20260803T130000
DTSTAMP:20260725T230905
CREATED:20260714T085435Z
LAST-MODIFIED:20260714T085649Z
UID:10000029-1785758400-1785762000@emwa.org
SUMMARY:Getting into Medical Writing: Regulatory Writing Q&A
DESCRIPTION:Getting into Medical Writing: Regulatory Writing Q&A \nMonday 3rd August 12pm CET – 1pm CET (1 hour) \nRegister Here
URL:https://emwa.org/event/getting-into-medical-writing-regulatory-writing-qa/
CATEGORIES:Q&A
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Ljubljana:20260923T130000
DTEND;TZID=Europe/Ljubljana:20260923T140000
DTSTAMP:20260725T230905
CREATED:20260330T150719Z
LAST-MODIFIED:20260703T104617Z
UID:10000025-1790168400-1790172000@emwa.org
SUMMARY:Visual Communication
DESCRIPTION:Wednesday 23rd September @ 13.00-14.00 CET \nDetails to follow
URL:https://emwa.org/event/visual-communication/
CATEGORIES:Webinar
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Ljubljana:20261030T130000
DTEND;TZID=Europe/Ljubljana:20261030T140000
DTSTAMP:20260725T230905
CREATED:20260330T150858Z
LAST-MODIFIED:20260330T150858Z
UID:10000026-1793365200-1793368800@emwa.org
SUMMARY:Leveraging Data Analytics for Efficient Multi-Country Regulatory Submissions
DESCRIPTION:Friday 30th October @13.00-14.00 CET \nDetails to follow
URL:https://emwa.org/event/leveraging-data-analytics-for-efficient-multi-country-regulatory-submissions/
CATEGORIES:Webinar
END:VEVENT
END:VCALENDAR