December 11th, 13.00 CET Diversity and inclusion in clinical trials Darius-Jean Namdjou, PhD Underrepresentation 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…
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…
The next CORE Reference Project webinar is scheduled for Friday 16 January 2026 (12.30-13.30 CET/11.30-12.30 UK time). 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…
January 27th, 13.00 CET From Questions to Clarity: Crafting Effective Briefing Books Anja Ramsay, PhD This 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…
13.00 CET A live Q&A Event Whether 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. Experienced medical writers Barbara Bartolini, Fiona Beck, and Alexander Lowe will be in the…
Clinical Evaluation Under MDR and IVDR: Practical Updates and Implementation Strategies for Medical Writers Hatem Rabeh, MD, MSc The 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…
13:00 - 16:00 CET The 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.…
March 25th, 13.00 CET Responding Effectively to Health Authority Questions Bhawna Basin, Christina Eichhorn Effective 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…
April 27th, 17.00 CET Darío Sánchez Martin, PhD Abstract: 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…
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 Please register your attendance: Register here This is your chance to hear important updates from the EMWA Executive Community, ask…