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Menu Back to 31-Preparing-for-a-US-FDA-Advisory-Committee-Meeting

Overview

An additional registration fee is required for all preconference tutorials. Register today for this tutorial.

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, and it is set up like an actual 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.”

Who should attend?

This tutorial is designed for professionals in regulatory affairs, clinical research leads, and corporate executives.

Learning objectives

  • 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).