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FDA's Approach in Harmonized Surveillance for Drugs and Biologics Safety and Quality Data
Session Chair(s)
Sri Mantha, MBA, MS
Director, Office of Strategic Programs
FDA, United States
This session will introduce a novel FDA approach that harmonizes surveillance for drugs and biologics safety and quality data, creating a cohesive end-to-end review and data management framework to support both safety and quality data regulated by the FDA.
Learning Objective : Describe FDA’s harmonized surveillance process for drugs and biologics safety and quality data with an integrated database approach; Identify the significant gain in efficiencies and effectiveness in drugs and biologics safety and quality reviews at FDA for both pre-market and post-market operations.
Speaker(s)
Industry Update
Sean Darcy
Darcy Consulting Group, United States
Principal
Industry Update
Andrew Bate, PhD, MA
GlaxoSmithKline, United Kingdom
Vice President, Head of Safety Innovation and Analytics
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