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[V3-S2] How to Build and Execute a Robust and Effective Clinical Quality Management System for the Upcoming ICH E6 Revision
Session Chair(s)
Satoshi Saeki, MSc
Head of Japan Operational Excellence, Medical Affairs, Japan
Astellas Pharma Inc., Japan
ICH E6 (ICH-GCP) revision is currently underway and is expected to be finalized as step 4 this November. One of the key revision points is to request sponsors to introduce and execute Clinical Quality Management System (CQMS) for clinical trials as their new responsibility. In this session, a representative from the TransCelerate CQMS initiative will provide an update on their current activities and future plans as a follow-up session from last year’s meeting. In addition, a Pfizer case study for effectiveness assessment on CQMS using metrics will be presented, followed by discussion on how to address CQMS execution challenges identified by PhRMA member companies.
Speaker(s)
Update on the TransCelerate Clinical Quality Management System (QMS) Initiative
Ann Meeker-O'Connell, MS
FDA, United States
Director, Office of Clinical Policy, Office of Clinical Policy and Programs, OC
Clinical Quality Management System Metrics and Effectiveness
Carol A. Bye
Pfizer Inc., United Kingdom
Vice President, Head of Pfizer Medical Quality Assurance
Challenges for Quality Management System Realization in Japan - From Discussion between PhRMA Member Companies -
Kiyomi Hirayama, PhD
Japan
Senior Director, Quality Management Unit Japan Development
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