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Tokyo Big Sight

Nov 15, 2015 9:30 AM - Nov 17, 2015 5:45 PM

3-11-1 Ariake, Koto-ku, Tokyo, 135-0063 Japan

12th Annual Meeting DIA Japan 2015

The registrants will have access to presentation PDFs through Tuesday, May 17, 2016.

[V6-S6] Towards ICH E6 Revision - Think about How Quality Management System (QMS) Can be Introduced in Clinical Trials

Session Chair(s)

Satoshi  Matsushita

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)

Naoyuki  Yasuda, MSc

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

Ann  Meeker-O'Connell, MS

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

Kiyomi  Hirayama, PhD

Merck/MSD Clinical Quality Management Model

Kiyomi Hirayama, PhD

MSD K.K., Japan

Senior Director, Quality Management Unit Japan Development

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