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Tokyo Big Sight

Nov 13, 2016 9:30 AM - Nov 15, 2016 5:30 PM

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

13th DIA Japan Annual Meeting 2016

[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

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)

Ann  Meeker-O'Connell, MS

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

Carol A. Bye

Clinical Quality Management System Metrics and Effectiveness

Carol A. Bye

Pfizer Inc., United Kingdom

Vice President, Head of Pfizer Medical Quality Assurance

Kiyomi  Hirayama, PhD

Challenges for Quality Management System Realization in Japan - From Discussion between PhRMA Member Companies -

Kiyomi Hirayama, PhD

MSD K.K., Japan

Senior Director, Quality Management Unit Japan Development

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