Topic: Briefing Books


Spotlight on Briefing Books
Episode 15: How to Streamline Regulatory Authority Meetings: Spotlight on Briefing Books

Welcome to TriloTalk episode 15, where we will dive into the critical document that plays a pivotal role in pharmaceutical development: The Briefing Documents (or briefing books/packs).

Join Barry and Maria as they explore the key elements of well-crafted Briefing Books, their importance in the regulatory process, and how to tailor these documents to the specific regulatory authority. 


How to Streamline Regulatory Authority Meetings
Streamlining meetings with regulatory authorities is a continually evolving process. But what role do briefing documents play, and what is the best way to produce these effectively?
Author: Maria Mascarenhas and Barry Drees
Journal: International Clinical Trials
Date: May 2022