Preparing for a US FDA Advisory Committee Meeting

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, 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”