What Management and Marketers should know about the Amarin Off-Label Case & what it means for marketing

  • On: October 27, 2015 at 8:30AM
  • Category: Conferences
  • Register:

Join Mark DuVal for a seminar on recent regulatory-related rulings, and the effect they will have on the affected industries.

Topics to be covered include:

  •  The U.S. Supreme Court speaks Sorrell vs. IMS Healthcare, Inc.
  • The 2nd Circuit weighs in Caronia and Amarin Pharmaceuticals and soon Pacira Pharmaceuticals
  • Where are the FDA and the Department of Justice at in all of this?
  • How do these cases impact government theories going forward?
  • Can companies promote for off-label use?
  • How is it different from off-label dissemination? 
  • What are the risks of prosecution today?
  • How do management teams and boards apply this in a practical way?
  • What about the use of disclosures and disclaimers?
  • Special challenges for 510(k) devices
Helping clients be appropriately aggressive, yet compliant. TM