UBC is a leading provider of Risk Management services. Our experts have designed, implemented and evaluated more than 100 RiskMap and REMS programs. Our Risk Management team has a global footprint and firm grasp of regulatory requirements in the U.S. and throughout Europe.
UBC is a leading provider of Risk Management services. Our experts have designed, implemented and evaluated more than 100 RiskMap and REMS programs, giving them a firm understanding of FDA and EMA requirements and the similarities and differences between the two. We consult with sponsors on a range of safety issues and can design and implement risk management plans, REMS, post-authorization safety studies (PASS), and other risk minimization programs globally. We are uniquely positioned to evaluate the effectiveness of these programs, which national regulatory bodies are asking for more often. Hear leading expert Annette Stemhagen, DrPH, FISPE, Senior Vice President, Safety, Epidemiology, Registries & Risk Management, discuss UBC’s depth of experience in Risk Management.