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Responding Effectively to Health Authority Questions
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 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.
Takeaway messages:
- Understand what health authority questions are and why health authorities issue them during the review of BLAs, MAAs, NDAs, and other global submissions.
- Accurately interpret regulatory intent and present evidence effectively, ensuring data are well‑organized, supported, and easy for reviewers to follow.
- Collaborate efficiently across functions to gather data, align on messaging, and develop cohesive responses under tight deadlines.
Level: Foundation/intermediate
Previous knowledge required: The following background knowledge is recommended:
- Experience in preparing regulatory submissions like NDA, BLA, and MAA.
- Proficient in the structure and requirements of Common Technical Document (CTD)‑formatted submissions.
- Regulatory knowledge about major health authorities such as EMA and FDA.
To register, please click here
