Component Type: Tutorial
CE: ACPE 3.25 Application UAN: 0286-0000-17-503-L04-P; CME 3.25; IACET 3.25; RN 3.25
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 short course is structured like an actual FDA Advisory Committee meeting, and presents best practices for preparing for meetings. What You Will Learn:
- What an advisory committee is
- How an advisory committee is structured
- Critical factors for advisory committee preparation
- How to design the most applicable preparation program for your team
- Top ten "best practices" and "must avoids"
Who should attend?
This course is designed for professionals in regulatory affairs, clinical research leads, and corporate executives.
Learning Objectives
At the conclusion of this course, participants should be able to:
- Identify the critical success factors in preparing for an advisory committee meeting
- Outline those factors that are most applicable to your team
- Design the most effective preparation strategy for your team(s)
