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[V6-S6] Towards ICH E6 Revision - Think about How Quality Management System (QMS) Can be Introduced in Clinical Trials
Session Chair(s)
Satoshi Matsushita
Director, R&D QA Department
Janssen Pharmaceutical KK, Japan
ICH E6 revision has been under discussion and the step 4 guideline will be published in November 2016 after step 2 in June 2016. One of the main focuses on ICH E6 revision is to introduce quality management approach into clinical trials in order to ensure quality. There will be a high possibility that some traditional approaches need to be reconsidered fundamentally. Risk-Based Monitoring, which sponsors have already implemented, is also one of the methods of quality management, but ICH E6 revisions request a more systematic approach at the trial level. Health authorities have also encouraged development of an integrated clinical quality management system in our organization. In this session, we will discuss what the QMS is, our expectation/issues for it and how to execute it from a practical point of view.
Speaker(s)
Impact of ICH E6 Revision on Quality Management Activities in Clinical Trials - From PMDA Point of View
Naoyuki Yasuda, MSc
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Associate Executive Director , Office of International Programs
TransCelerate Clinical Quality Management System Initiative Update
Ann Meeker-O'Connell, MS
FDA, United States
Director, Office of Clinical Policy, Office of Clinical Policy and Programs, OC
Merck/MSD Clinical Quality Management Model
Kiyomi Hirayama, PhD
Japan
Senior Director, Quality Management Unit Japan Development
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