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DIA 2021 Global Annual Meeting

GCP Quality and Compliance: The Regulator’s Perspective

Session Chair(s)

David Fryrear, MS

David Fryrear, MS

  • Executive Vice President and Head of Quality Assurance, Medical and Development
  • 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)

David C. Burrow, JD, PharmD

Panelist

David C. Burrow, JD, PharmD

  • Director, Office of Scientific Investigations, OC, CDER
  • FDA, United States
Hocine Abid, MD, MBA

Panelist

Hocine Abid, MD, MBA

  • National Manager, Regulatory Operations and Enforcement Branch
  • Health Canada, Canada
Paula Walker, MA

Panelist

Paula Walker, MA

  • Deputy Head of Inspectorate, Inspection, Enforcement & Standards Division
  • Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom