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Best Practice for Advisory Committee Meeting Preparation
Session Chair(s)
Chris Miller, MS
Biostatistician, Communications Strategist, Medical Writer, 3D Communications, United States
Often times, FDA requests pharmaceutical sponsors participate in an Advisory Committee meeting during the review of a NDA/sNDA. Understanding the best practices for preparation of an advisory committee meeting (slide deck, briefing book, review of FDA's advisory committee brief) is crucial and critical to its success.
Learning Objective : Discuss how to generate a quality briefing book; Recognize considerations for preparing for the Advisory Committee meeting such as expectation and FDA information needs.
Speaker(s)
Jeffrey M. Dayno, MD
Chief Executive Officer, President, Harmony Biosciences, United States
Effective Preparation for an FDA Advisory Committee Meeting: Applying Lessons from Abuse-Deterrent Opioids
John Markman, MD
Professor of Neurosurgery and Neurology, University of Rochester, United States
Effective Preparation for an FDA Advisory Committee Meeting: Applying Lessons from Abuse-Deterrent Opioids
Michael Bourque, MS
Director of Global Submissions, Synchrogenix, a Certara Company, United States
FDA Advisory Committee Slide Preparation: Doing More with Less
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