RAPS Twin Cities Chapter: FDA Advisory Committee 101: The BasicsAdd to calendar
Wednesday, March 29, 2017
5:30 pm – 8:30 pm
Location: Saint Cloud State University At Plymouth 9750 Rockford Road Plymouth, MN 55442
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 firstname.lastname@example.org to learn about the special student registration rate.
Registration Ends Wednesday, March 29, 2017