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DTSTART;TZID=Europe/Madrid:20260325T130000
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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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