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Tuesday, June 18 • 4:30pm - 5:30pm
#277: FDA's Approach in Harmonize Surveillance for Drugs and Biologics Safety and Quality Data

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-609-L04-P; CME 1.00; RN 1.00

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 Objectives

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.

Chair

Sri Mantha, MBA, MS

Speakers
avatar for Sri Mantha

Sri Mantha

Director, Office of Strategic Programs, CDER, FDA, United States
Sridhar (Sri) Mantha is currently Director of the Office of Business Informatics (OBI) at the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration. As the Director of OBI, Sri is charged with leading informatics development to modernize CDER's drug regulatory... Read More →

Tuesday June 18, 2024 4:30pm - 5:30pm PDT
Room 11AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  01: ClinSafety-PV, Session