Event

AdvaMed MTLI seminar on Combination Products: An Intersection with a Future

March 31, 2011 {ml-event-to} April 01, 2011

Morgan Lewis' partner Phoebe Mounts will present "'Post-Approval Changes for Combination Products" at the AdvaMed MTLI seminar on Combination Products: An Intersection with a Future

Sessions will cover:

  • Primary Mode of Action and Request for Designation
  • The effect of different submission routes on the premarket regulatory process
  • Cross-labeling
  • The relationship between GMP and QSR
  • Issues with combination product marketing claims
  • Current and anticipated adverse event reporting
  • Logistical challenges of coordinating timelines and efforts for drugs and devices

When:
Thursday, March 31 - Friday, April 01, 2011

Where:
AdvaMed
701 Pennsylvania Ave., NW
Suite 800
Washington, DC 20004