One of the provisions of the Food and Drug Administration Amendments Act of 2007 (FDAAA) is that the FDA requires manufacturers to submit a Risk Evaluation and Mitigation Strategy (REMS) when a drug or biologic first comes on the market, or later if they become aware of new safety data about the drug. What risk signals should be looked for early in the development process?
In this audio conference we present case studies of various levels of REMS requirements and focus on how to use post-market surveillance requirements to support your product safety profile. Meeting the challenges raised by FDAAA through optimal risk management and utilizing integrated actvities that begin with early clinical testing are key, and must continue throughout the product lifecycle.
Benefits & Risks Throughout the Product Lifecycle: How to Strike a Balance in a Post-FDAAA World is being presented by Dr. Edgar Adams & Robin Carter, Executive Director, Epidemiology & Senior Director, Risk Management Operations, with Covance, and airs on Tuesday, May 5, 2009. For more details or to register for this conference, please visit our site at www.fxconferences.com
