Preparing for a US FDA Advisory Committee Meeting

Venue: Drug Information Association, Inc

Location: Horsham, PA, Pennsylvania, United States

Event Date/Time: Oct 20, 2011 End Date/Time: Oct 20, 2011
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Description

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, you not only must thoroughly explain but also defend, in detail, your product in a highly visible, high-stakes public meeting. This course 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”



Learning Objectives:

At the conclusion of this course, 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:
• Regulatory affairs professionals
• Clinical research leads
• Corporate executives

Event Code:
11442

Venue

Enterprise Drive Suite 200
Horsham, PA
Pennsylvania
United States
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