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Tuesday, June 29 • 2:00pm - 3:00pm
#245 SL: GCP Quality and Compliance: The Regulator’s Perspective

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-21-580-L04-P; CME 1.00; IACET 1.00; RN 1.00

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 Objectives

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.

Chair

David Fryrear, MS

Speaker

Panelist
David C. Burrow, JD, PharmD

Panelist
Hocine Abid, MD, MBA

Panelist
Paula Walker, MA



Speakers
avatar for Paula Walker

Paula Walker

Head of Compliance (GCP, GPvP, GLP & GxP Expert Circle), Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Paula Walker has been with the MHRA since 2009, joining as a GCP inspector, and subsequently moving to the role of Operations Manager for the GCP team in 2013. Paula is currently the Head of Compliance (1) responsible for the GCP, GPvP, GLP inspections teams and GxP Expert Circle... Read More →
avatar for David Fryrear

David Fryrear

Executive Vice President and Head of Quality Assurance, Astellas, United States
David Fryrear, M.S., is Executive Vice President and Head of Quality Assurance for Astellas. He has responsibility for providing the global vision, leadership and strategic direction for Quality Assurance, from the earliest stages of research, through clinical development and commercialization... Read More →
avatar for Hocine Abid

Hocine Abid

National Manager, Regulatory Operations and Enforcement Branch, Health Canada, Canada
Dr. Hocine Abid is currently the national manager for Health Canada’s (HC) clinical trial compliance and Enforcement (C&E) program is in charge of conducting inspections of clinical trials at Canadian and foreign sites. Before this, he occupied different roles in various regulatory... Read More →
avatar for David Burrow

David Burrow

Director, Office of Scientific Investigations, OC, CDER, FDA, United States
David Burrow currently serves as the Director of the Office of Scientific Investigations (OSI), within the U.S. Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Office of Compliance (OC). In this role, he is responsible for the strategic administration... Read More →


Tuesday June 29, 2021 2:00pm - 3:00pm EDT
TBD Virtual Event Horsham, PA 19044
  08: RD Quality-Compliance, Forum