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Virtual Event

Jun 14, 2020 9:00 AM - Jun 18, 2020 5:00 PM

(Eastern Standard Time)

Fort Washington, PA 19034

DIA 2020 Global Annual Meeting

GCP Quality and Compliance: The Regulators’ Perspective

Session Chair(s)

David  Fryrear, MS

David Fryrear, MS

Executive Vice President and Head of Quality Assurance

Astellas, United States

As the clinical trials become more complex and the science behind innovative therapies more advanced, the quality objectives of clinical development remain unchanged – protection of research volunteers and data integrity. A comprehensive Quality Management System, sophisticated risk-based approaches, and robust oversight models are now the standard for executing a compliant clinical trial and lapses in these and other GCP expectations continue to arise, potentially delaying delivery of important new therapies to patients. 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

FDA Update

David C. Burrow, JD, PharmD

FDA, United States

Director, Office of Scientific Investigations, OC, CDER

Sean  Kassim, PhD

FDA Update

Sean Kassim, PhD

FDA, United States

Director, Office of Study Integrity and Surveillance, OTS, CDER

Andrew  Gray, PhD

MHRA Update

Andrew Gray, PhD

Johnson & Johnson, United Kingdom

Director, QA Clinical Therapeutic Area Head

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