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Tuesday, June 16 • 9:30am - 10:30am
#214 L: GCP Quality and Compliance: The Regulators’ Perspective

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-742-L04-P; CME 1.00; IACET 1.00; RN 1.00

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 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 William Fryrear, MS

Speaker

FDA Update
David C. Burrow, JD, PharmD

FDA Update
Sean Y. Kassim, PhD

MHRA Update
Andrew Gray, PhD



Speakers
avatar for Andrew Gray

Andrew Gray

Deputy Director, Inspection Enforcement and Standards, Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Andrew joined the MHRA in January 2003. In 2006 Andrew took on the role of Heads of the UK Good Laboratory Monitoring Authority and subsequently the role of Unit manager for half of the MHRA’s Inspectorate. In 2018 Andrew was appointed as Head of the MHRA’s Inspectorate and Deputy... Read More →
avatar for Sean Kassim

Sean Kassim

Director, Office of Study Integrity and Surveillance, OTS, CDER, FDA
Sean serves as the Director of the Office of Study Integrity and Surveillance, CDER/FDA. He oversees the bioavailability/bioequivalence (BA/BE) and GLP inspection programs that inspect and review conduct of regulated pharmaceutical premarket bioanalytical and non-clinical researc... Read More →
avatar for David Burrow

David Burrow

Director, Office of Scientific Investigations, OC, CDER, FDA
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 →
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 the Quality Assurance for Astellas and has responsibility for providing the global vision, leadership and strategic direction for Quality Assurance, from the earliest stages of research, through clinical development, and... Read More →


Tuesday June 16, 2020 9:30am - 10:30am EDT
TBD Virtual Event Horsham, PA 19044
  08: R-D Quality-Compliance, Forum