概要

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"

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参加対象

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

学習目的

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)

#30: Preparing for a US FDA Advisory Committee Meeting

DIA 2017 is located at:

概要

参加対象

学習目的

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