The field of medical product safety continues to grow in complexity, with both clinical trial safety and postmarketing pharmacovigilance becoming ever more critical in the development and ongoing evaluation of safe use of marketed medical products. The inherent limitations of premarketing testing and constant focus on the risks associated with medical product use have fostered new thinking and methods for monitoring the evolving safety profiles of marketed products throughout their life cycle. Further, while the field of risk management has added a new dimension to product safety, as a maturing discipline it requires ongoing refinement in order to enhance its applicability and value to public health.

This comprehensive four-day program will address the current complexities and controversies in pharmacovigilance and risk management throughout all phases of development and marketed use via discussion of the latest safety-related regulatory initiatives, descriptions of how to optimally utilize epidemiological, clinical pharmacological and other techniques, presentation of illustrative examples of risk management strategies, and debate as to how all of this can be pulled together into an effective organizational “System”.