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…
To be held in the beautiful city of Barcelona
Thursday 11th June @ 4pm CET Speakers: Barry Drees, PhD and Louise Martinsson, PhD Discussing: Is "faster drafting" solving the wrong problem? or shifting the burden into downstream QC Lean writing vs. legacy habits- Why most documents still say more than regulators Consistency at scale- Why global teams struggle to produce stable, aligned outputs AI…
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…