Drug Information Association, Inc, Horsham, PA USA
Mar 21 2011 8:00AM - Mar 22 2011 4:00AM
Fundamental Concepts of Clinical Safety Learn how to comply with FDA and European regulations for clinical safety. What you will learn • Fundamental concepts of drug safety and pharmacovigilance and their application to clinical development • How to comply with FDA and European regulations for clinical safety • How to pass a preapproval safety inspection • Proven concepts of premarketing risk assessment and its important role in the development of Risk Evaluation and Mitigation Strategies (REMS) • How to effectively use signaling tools and techniques to support premarketing risk assessment Event Code: 11422
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