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Abstract:
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The ASA Biopharm Safety Statistics Working Group interviewed industry leaders and surveyed statisticians on whether current safety monitoring practices are keeping pace with regulatory guidance and statistical methodology. In this session, we will report industry wide results, having (1) surveyed individuals, including variation in company roles and processes, and related statistical methods, software tools and databases and (2) surveyed relevant safety guidance from CIOMS, ICH, and regulatory bodies in Europe, Japan and United States. Insights will be valuable to companies at all stages of incorporating recent regulatory changes, such as FDA's IND Safety Final Rule and Safety Assessment recommendations into their practices.
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