Webinar: Continuing Developments in Risk Management and the Pharmaceutical Industry: How the REMS Procedure Has Evolved as a Critical Factor in Drug Development and Commercialization
When the Food and Drug Administration Amendments Act of 2007 (FDAAA) established the Risk Evaluation and Mitigation Strategies (REMS) program, many considered them a continuation of pre-existing risk minimization programs previously implemented by the FDA. However, in the period since the newly authorized REMS process has been operating, the pharmaceutical industry has seen profound changes in the FDA's attitude toward risk identification and mitigation.
This webinar will provide an overview of FDA risk minimization activities since implementation of REMS. In addition, we will examine and discuss the significant impact these regulatory changes have had on every aspect of the pharmaceutical industry's practices, from the earliest stages of drug development to preparations for product approval and launch through the critical changes in post-marketing adverse event surveillance activities and their impact on product liability defense efforts.