Overview

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.
Course Level: Beginner

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 ten "Best Practices" and "Must Avoids"

Who should attend?

Regulatory affairs professionals
Clinical research leads
Corporate executives

Learning objectives

Participants who complete this training 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 teams

Have an account?

Preparing for a US FDA Advisory Committee Meeting

Overview

What you will learn

Who should attend?

Learning objectives

Be informed and stay engaged.