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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
Supervisory Consumer Safety, OBIMO, ORA, FDA, United States
FDA Update
Senior Physician, OSI, OC, CDER, FDA, United States
Industry Perspective
Global Head Country Development Quality, Novartis , United States
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