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DTSTAMP:20260725T095302
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LAST-MODIFIED:20260212T131543Z
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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
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DTSTART;TZID=Europe/Belgrade:20260320T130000
DTEND;TZID=Europe/Belgrade:20260320T160000
DTSTAMP:20260725T095302
CREATED:20260309T173135Z
LAST-MODIFIED:20260309T173421Z
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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
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DTSTART;TZID=Europe/Madrid:20260325T130000
DTEND;TZID=Europe/Madrid:20260325T140000
DTSTAMP:20260725T095302
CREATED:20260128T102111Z
LAST-MODIFIED:20260202T165213Z
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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
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