FDA Device Advisory Panel Review Process

Webinar Details

whenWhen?  Wednesday, Sept. 24, 2014
whereWhere? Your Office
whenTime? 1:30 p.m. – 3:00 p.m. EDT

Register

Webinar plus Audio CD/Transcript $487
Webinar only $287
24/7 Encore plus CD/Transcript $487
24/7 Encore Presentation $287
Audio CD/Transcript $287

FDA Device Advisory Panel Review Process
How to Ensure Successful Outcomes

Would you leave your health to an uncertified doctor? What about your car to a mechanic with no expertise on your model? Of course you wouldn’t. It’s completely illogical right?

So why would you walk into a FDA advisory panel without inside tips and tricks from two device advisory panel professionals?

FDAnews has teamed Chris Sloan, Principal Consultant at Quintiles Consulting and former FDA device advisory panelist who has attended over 50 FDA advisory panels, and Michael Morton, Medtronic’s Vice President for global regulatory affairs, a four year FDA advisory circulatory panelist veteran.

On September 24, they will share their combined five decades of device regulatory experience to make sure your product’s next advisory panel appearance will be a breeze.

FDA advisory appearances can definitely raise a devicemaker’s anxiety level. Stop sweating while the world looks on — the trade press, the investment community, and your competitors.

Get an insider’s perspective – register today!

Attendees will learn:

  • The various roles of advisory panel participants
  • How much lead time you’ll need to prepare for advisory panel review
  • What material of the sponsors will be made public?
  • What will the sponsor know prior to the meeting?
  • What is the protocol for an advisory panel meeting?
  • Who may speak at an advisory panel meeting? And when?
  • What are the possible outcomes of advisory panel review?
  • What does the sponsor do after the panel meets?
  • And much more

This is a must attend event for everyone involved in advisory panel presentations. Whether you’re before the microphones or behind the scenes, old hand or new hire, this session will polish your skills and increase the likelihood of FDA approvals.