戻る Agenda
GCP Quality and Compliance: The Regulators’ Perspective
Session Chair(s)
David Fryrear, MS
Chief Quality Officer
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)
FDA Update
David C. Burrow, JD, PHARMD
FDA, United States
Director, Office of Scientific Investigations, OC, CDER
FDA Update
Sean Kassim, PHD
FDA, United States
Director, Office of Study Integrity and Surveillance, OTS, CDER
MHRA Update
Andrew Gray, PHD
Johnson & Johnson, United Kingdom
Director, QA Clinical Therapeutic Area Head