Preparing for a US FDA Advisory Committee Meeting
|Event Date/Time: Jun 24, 2012||End Date/Time: Jun 24, 2012|
Appearing before a US Food and Drug Administration (FDA) Advisory Committee can be one of the most challenging and grueling experiences for any drug, device, or biologic team. In just eight hours, products must be thoroughly explained and defended in detail during a highly visible, high-stakes public meeting. This course teaches the critical factors and 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?
How to prepare for an Advisory Committee meeting
How to design the most applicable preparation program for your team
Top 10 best practices and actions to avoid
Who Should Attend
Regulatory affairs professionals
Clinical research leads
Learning Objectives Participants who attended this event should be able to:
Identify the critical factors in preparing for a successful Advisory Committee meeting
Recognize and evaluate factors that are most applicable to your team
Design the most effective preparation for your teams
Martha Arnold, MBA
PharmApprove, United States
Laurie F. Smaldone, MD
Pharmapprove, United States
Taft and Partners, United States