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How Will the Increasing use of Real-World Evidence for Regulatory Decision-Making Impact QA Strategies and GCP Inspections?
Session Chair(s)
Andrew Gray, PhD
Director, QA Clinical Therapeutic Area Head, Johnson & Johnson, United Kingdom
This session will bring regulators and industry quality experts together to explore how quality management systems can be developed to meet the challenges real-world evidence presents to QA activities and regulatory inspection expectations.
Learning Objective : Evaluate quality challenges associated with the use of real-world evidence as part of regulatory studies; Discuss how to apply proportionate risk-based quality assurance activities which meet regulatory expectations.
Speaker(s)
FDA Update
L'Oreal Walker
Supervisory Consumer Safety, OBIMO, ORA, FDA, United States
FDA Update
Lee H. Pai-Scherf, MD
Senior Physician, OSI, OC, CDER, FDA, United States
Industry Perspective
Abi Seifert, MBA
Global Head Country Development Quality, Novartis , United States
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