Briefing Books Webinar

January 27th, 13.00 CET

From Questions to Clarity: Crafting Effective Briefing Books

Anja Ramsay, PhD

This webinar explores briefing books as strategic tools for regulatory interactions with agencies such as EMA and FDA. These documents inform agencies about development programs and frame questions requiring guidance, serving as a foundation for scientific dialogue rather than simple summaries. EMA emphasizes written scientific advice and mandatory templates, allowing flexible timing, while FDA relies on formal meetings (Type A, B, C) with structured timelines and no strict template. Essential components include background, development overview, questions with rationale, and supporting data. Strategic writing principles—clarity, consistency, and alignment with development goals—are critical, alongside tailoring content to agency expectations and anticipating regulatory concerns. The webinar also addresses challenges such as limited training on briefing books and highlights global practices for other agencies, underscoring the vital role of medical writers in ensuring compliance and facilitating successful regulatory outcomes.

Takeaway messages:

· Takeaway message #1: Briefing books are strategic tools, not summaries; they enable structured dialogue with regulatory agencies to inform them about development plans and frame precise questions for guidance.

· Takeaway message #2: Be aware of the main differences: EMA provides written scientific advice, has a mandatory template with flexible timing. FDA holds formal meetings (Type A, B, C), has no strict template, but follows structured timelines.

· Takeaway message #3: Well-prepared briefing books reduce regulatory risk, streamline interactions, and support efficient drug development. Strategic writing is critical to ensure clarity, consistency, and alignment with development goals.

Level: Foundation/Intermediate

Previous knowledge required: To fully benefit from the webinar, the following background knowledge is recommended:

· Basic Regulatory Framework: Familiarity with drug development stages (preclinical, clinical phases) and regulatory submissions like IND, NDA, and MAA.

· Regulatory Agencies: Awareness of major agencies such as EMA and FDA, and their roles in approving medicines.

· Medical Writing Fundamentals: Understanding of structured documents, clarity principles, and compliance with guidelines.

· Clinical Development Concepts: Knowledge of study design, endpoints, comparators, and terminology (e.g., orphan drugs, CHMP, SAWP).

Register here