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Tokyo Big Sight

Nov 10, 2019 9:30 AM - Nov 12, 2019 5:40 PM

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

16th DIA Japan Annual Meeting 2019

Delivering Rational Medicine for All People in the Globe

[S04] Examples of Clinical QMS Introduction: Risk Analyses and Issue Management

Session Chair(s)

Hirotaka  Inoue, PhD, MBA

Hirotaka Inoue, PhD, MBA

Head, Leading Changes Office, Japan Development & Medical Affairs Division

GlaxoSmithKline K.K., Japan

Many attendees of previous DIA Japan Annual Meetings were bewildered when introducing the Clinical Quality Management System (QMS) to your organizations. One of the reasons for this is lack of facilitators for application of the tools. This session targets all stakeholders in clinical operations from the job site perspective, and will present risk analyses and issue management by using DMAIC processes, and successful outcomes. As a result, the session will provide hints for successful implementation of clinical QMS. Case studies of QMS tools published by a task force in the Data Science Division of the Japan Pharmaceutical Manufacturers Association may also prove helpful.


Kiyomi  Hirayama, PhD

Clinical QMS Implementation & Challenges

Kiyomi Hirayama, PhD


Senior Director, Quality Management Unit Japan Development

Chiharu  Funaki, MSc

The Journey to a Practical Clinical QMS : Challenges That Have Become Clear After the Implementation of ICH E6 (R2)

Chiharu Funaki, MSc

Daiichi Sankyo, United States

Associate Director

Goshi  Ozawa, MS

Methods, Tools and Cases for Success of Issue Management in Clinical QMS

Goshi Ozawa, MS

Juniper Therapeutix K.K., Japan

Representative Director & President, Japan / R&D Head

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