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Emerging Safety Sciece

April 23-24, 2007
FDA White Oak Conference Center
Silver Spring, MD

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Safety Science is a rapidly changing field, leading to new developments in the methods and technologies used to detect and interpret safety signals.  Predictive tools are needed to accurately screen out candidates, early in development, that are most likely to have serious, undesired effects and identify those most likely to become safe and effective treatments. The goal of this workshop was to present and collaboratively discuss novel, cutting-edge methodologies and techniques that are being used by academicians, researchers, drug manufacturers and regulatory scientists.  It also explored how this new knowledge and technology may be applied for both drug development and post-approval regulatory/ safety review processes.  Day 1, Biology of Adverse Events, will cover primarily preclinical safety issues, and Day 2, Datamining from the Medical Experience, will focus on post-market surveillance and pharmacovigilance topics.

This event was free and open to the public.