概览

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

内容纲要

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"

谁应该参加？

Regulatory affairs professionals
Clinical research leads
Corporate executives

学习目标

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

Preparing for a US FDA Advisory Committee Meeting

概览

内容纲要

谁应该参加？

学习目标

获得信息并保持参与