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…
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…
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…
Wednesday 17th June @ 13.00-13.50 CET Our 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: Title: ICH M11: an integrated and forward‑looking CeSHarP perspective Abstract: Viewed through a regulatory medical writing lens, ICH M11 (CeSHarP…
Thursday 18th June @ 13.00-14.00 CET Vena Verga-Danemar, J.D., LL.M. (Tilburg), LL.M.-MAS (Geneva) Freelance 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…
Thursday 9th July @13.00-14.00 CET Ana Sofia Correia, Medical Translator and Writer Medical 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. The…