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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

Clinical QMS Implementation & Challenges

Kiyomi Hirayama

  • Director, Quality Management Unit
  • MSD K.K., Japan
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

  • Associate Director, Clinical Quality Management Group, Development Function
  • Daiichi Sankyo Co., Ltd., Japan
Goshi  Ozawa, MS

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

Goshi Ozawa, MS

  • Exective officer, RWD dept.
  • Real World Data Co., Japan