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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… |
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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.… |
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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… |
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