Lessons Learned When Implementing A Risk Management Program

By Annette Stemhagen, DrPH, FISPE Senior Vice President and Chief Science Officer, Safety, Epidemiology, Registries, and Risk Management

Insights into the type of REMS program which may be required can be found by looking at recently approved REMS or those already in the marketplace. The FDA often relies on precedents when determining REMS requirements. For some products, the FDA has required Shared System REMS; for these, multiple sponsors must operate together under one REMS. UBC has the knowledge gained from designing and implementing multiple REMS across different therapeutic areas and targeting different risks.