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 marketed use of medical products. The inherent limitations of premarketing testing and ongoing 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 an evolving 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 through discussion of the latest safety-related regulatory initiatives, description of how to optimally utilize epidemiological, clinical pharmacological and other techniques, and presentation of “state of the art” risk management strategies using illustrative examples and case studies.