We invite you to listen to the PRA Risk Management, Epidemiology and Late Phase Operational experts who are currently consulting, designing and conducting REMS activities under the new FDAAA regulations. These experts give insight into current issues concerning REMS, such as risk management activities, observational safety-surveillance studies and performance-linked access programs. They also discuss the potential payoff from the new REMS requirements, as well as which REMS requirements have been proposed for incorporating adaptive designs.
In this audio conference the speakers present various REMS strategies based on a “tiered” approach, as well as some recent case studies. In addition, the presenters cover lessons learned and program components to consider, based on current FDA thinking and requirements for a REMS.
Meeting the Requirements: Blending REMS Science & Operational Execution is being presented by Mark Nelson Tyrrell, Kathleen Kushner & Jerome Wilson, Director, Safety and Risk Management, Scientific Affairs Director & Senior Scientific Affairs Director, with PRA International and airs on Tuesday, June 16, 2009. For more details, please visit our site at www.fxconferences.com
