RAPS Twin Cities Chapter: FDA Advisory Committee 101: The Basics

Wednesday, March 29, 2017, 5:30 PM - 8:30 PM ET

Is your company developing a first-of-a-kind or first-in-class product? Are there challenges or complexities to your data? Is your submission controversial or of public interest in any way? If so, an FDA advisory committee may be in your future.

FDA's advisory committees usually have only one day to provide independent expert advice to the Agency on a range of complex scientific, technical and policy issues. Since the Agency normally follows their advice, for sponsors, an FDA Advisory Committee is the wrong time for an original thought.

During this dynamic session, you will learn what an advisory committee is and why early preparation is key. There are critical components in preparing for this public regulatory meeting, such as:

  • the development of a 45-90 minute company presentation
  • the submission of a thorough, yet concise, briefing document
  • the need to respond to important questions from a diverse group of panel members

This event is coordinated by the RAPS Twin Cities Chapter and is intended to encourage knowledge sharing and community development. Dinner will be provided. RAC holders may claim two RAC recertification credits.

 Contact RAPS Solutions Center at +1 301 770 2920, ext. 200, or email raps@raps.org to learn about the special student registration rate.