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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, CDER
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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