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Tuesday, June 20 • 2:00pm - 3:15pm
#247: Best Practice for Advisory Committee Meeting Preparation

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Component Type: Forum
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

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 Objectives

Discuss how to generate a quality briefing book; Recognize considerations for preparing for the Advisory Committee meeting such as expectation and FDA information needs.

Chair

Chris Miller, MS

Speaker

Effective Preparation for an FDA Advisory Committee Meeting: Applying Lessons from Abuse-Deterrent Opioids
Jeffrey M. Dayno

Effective Preparation for an FDA Advisory Committee Meeting: Applying Lessons from Abuse-Deterrent Opioids
John Markman, MD

FDA Advisory Committee Slide Preparation: Doing More with Less
Michael Bourque, MS



Moderators
avatar for Chris Miller

Chris Miller

Biostatistician, Communications Strategist, Medical Writer, 3D Communications
Chris Miller is a biostatistician with broad experience in the design, analysis, and interpretation of clinical trials. He guides teams to present data effectively for regulatory submissions and FDA advisory committee meetings. Prior to joining 3D, Chris was a senior biostatistic... Read More →

Speakers
avatar for Michael Bourque

Michael Bourque

Associate Director, Principal Regulatory Writer, Synchrogenix, a Certara Company
Michael Bourque has over 17 years of medical writing and clinical research experience across a wide range of therapeutic areas including infectious diseases, vaccines, pain, oncology, and pediatric medicine. He is currently Associate Director at Synchrogenix. In addition to servi... Read More →
avatar for Jeffrey Dayno

Jeffrey Dayno

Chief Medical Officer, Egalet Corporation
avatar for John Markman

John Markman

Professor of Neurosurgery and Neurology, University of Rochester
John Markman founded and directs the University of Rochester’s Neuromedicine Pain Management Center and Translational Pain Research Program, a leading academic research site for the clinical study of chronic pain. John, a Professor of Neurosurgery and Neurology, has chaired the... Read More →


Tuesday June 20, 2017 2:00pm - 3:15pm
S504abc McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616