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A Briefing Document (BRD), also called briefing book or briefing package, is a compilation of relevant information provided to a regulatory decision-making body/entity. Its purpose is to summarize critical information and support interactions with health authorities, at several stages of development (preclinical, clinical, also post authorization). Feedback is provided by the health authority during a meeting, or in writing.
Besides background information, the BRD formulates different questions with the goal of getting the health authority to address the issues. To facilitate this process, the document contains proposed solutions for the presented questions and appropriate background information. These questions can concern quality (manufacturing, chemical, pharmaceutical and biological testing), non-clinical (toxicological and pharmacological tests), clinical aspects (studies in human participants, including clinical pharmacological trials), or issues relating to interpretation and implementation of guidelines.
There are many types of BRDs, which need to be tailored to the needs of the situation and to the requirements of the health authority concerned. These documents often require, depending on the issues, input from different functions (CMC, preclinical, clinical, regulatory, …).
The BRD is not updated; however, revisions of draft briefing books during the procedure are possible, to implement health authority feedback.
The Medical Writer can play an important role in the document development process (eg, compile contributions, circulate for review, implement comments). If applicable, the Medical Writer can also help to draft the clinical contribution.