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Bethesda North Marriott Hotel and Conference Center

Apr 08, 2019 1:45 PM - Apr 10, 2019 9:45 PM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

Drug Safety and Pharmacovigilance Across the Product Lifecycle

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Session 6: FDA Guidance for Industry on Safety Reporting

Session Chair(s)

Mark Vieder, MBA, RPh

Vice President, Drug Safety and Pharmacovigilance

Biorasi, LLC, United States

This session will review the FDA guidelines on safety reporting that provide recommendations for how sponsors of INDs can identify and evaluate important safety information as well as recommendations for a systematic approach to IND safety reporting.