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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
Acting Chief Information Officer, 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)
Sean Darcy
Principal, Darcy Consulting Group, United States
Industry Update
Andrew Bate, PHD, MA
Vice President, Head of Safety Innovation and Analytics, GSK, United Kingdom
Industry Update
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