Pharmacovigilance Strategies Workshop

Revision 2, of GVP Module XVI, provide guidance use of additional risk minimisation measures including the selection tools and their evaluation of their effectiveness. Additional risk minimisation measures include educational materials, controlled access programmes and controlled distribution systems. This session will explore some examples of such measures and the measurement of effectiveness to help stimulate discussion. There will be perspectives from Industry and the UK regulatory agency. In addition to hearing from the speakers, attendees will be encouraged to share their experience as part of the Panel Discussion.