8:30 am EST - 3:45 pm EST

Past Event

Legal Issues in Active Medical Product Surveillance

Monday, March 08, 2010

8:30 am - 3:45 pm EST

Washington Marriott at Metro Center
Grand Ballroom

775 12th St. NW
Washington, DC

The Engelberg Center for Health Care Reform at Brookings hosted a small expert workshop to discuss legal issues in the development and implementation of FDA’s Sentinel Initiative for medical product safety surveillance.

The one-day workshop featured productive discussion and exchange of ideas with panelists representing government, academia, and the private sector on topics including:

  • Protecting patient privacy in medical product safety surveillance;
  • Appropriate human-subject protections for research use of Sentinel System data; and
  • Addressing legal liability in medical product safety surveillance.