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GCP Quality and Compliance: The Regulator’s Perspective
Session Chair(s)
David Fryrear, MS
Chief Quality Officer
Astellas, United States
In this forum, leaders from regulatory authorities will present trends they are seeing in inspections, discuss emerging compliance challenges, and answer questions on expected practices that support success in quality in clinical development.
Learning Objective : Discuss trends observed in recent inspections and understand specific areas of interest of regulatory authorities; Describe how quality management systems and risk-based approaches need to evolve to address emerging challenges; Recognize regulatory expectations.
Speaker(s)
Panelist
David C. Burrow, JD, PHARMD
FDA, United States
Director, Office of Scientific Investigations, OC, CDER
Panelist
Hocine Abid, MD, MBA
Health Canada, Canada
National Manager, Regulatory Operations and Enforcement Branch
Panelist
Paula Walker, MA
Roche, United Kingdom
Global Head of Risk Based Quality Management