#57: Preparing for a US FDA Advisory Committee MeetingDay & Time:
June 23, 9:00AM - 3:45PMRoom Number:
Taft and Partners, United States
Laurie F. Smaldone, MD
Pharmapprove, United StatesDescription:Maximize your learning while attending the DIA 2013 49th Annual Meeting! Receive $100 off of your DIA 2013 meeting registration by registering for two half day tutorials or one full day tutorial. Purchases must be made at the same time in order to receive the discount.
What are the critical factors when preparing for an FDA Advisory Committee meeting? Appearing before an FDA Advisory Committee can be one of the most challenging and grueling experiences for any drug, device, or biologic team. In just eight short hours with the FDA Advisory Committee, you not only must thoroughly explain but also defend, in detail, your product in a highly visible, high-stakes public meeting. This tutorial teaches best practices for preparing for an FDA Advisory Committee Meeting.
What You Will Learn
• What is an Advisory Committee?
• What does an Advisory Committee “Look Like”?
• Critical factors for Advisory Committee preparation
• How to design the most applicable preparation program for your team
• Top ten “Best Practices” and “Must Avoids.”
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At the conclusion of this tutorial, participants should be able to:
• Identify the critical factors in preparing for a successful Advisory Committee meeting
• Recognize and evaluate those factors that are most applicable to your team
• Design the most effective preparation for your team(s)Target Audience:
This tutorial is designed for professionals in regulatory affairs, clinical research leads, and corporate executives.