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[S04] Examples of Clinical QMS Introduction: Risk Analyses and Issue Management
Session Chair(s)
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.
Speaker(s)
Clinical QMS Implementation & Challenges
Kiyomi Hirayama, PhD
Japan
Senior Director, Quality Management Unit Japan Development
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
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