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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)
Effective Preparation for an FDA Advisory Committee Meeting: Applying Lessons from Abuse-Deterrent Opioids
Jeffrey M. Dayno, MD
Harmony Biosciences, United States
Chief Executive Officer, President
Effective Preparation for an FDA Advisory Committee Meeting: Applying Lessons from Abuse-Deterrent Opioids
John Markman, MD
University of Rochester, United States
Professor of Neurosurgery and Neurology
FDA Advisory Committee Slide Preparation: Doing More with Less
Michael Bourque, MS
Synchrogenix, a Certara Company, United States
Director of Global Submissions