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[V7-S1] Implementing Quality Management System (QMS) in Your Trials and Understanding the Purpose and Concept
Session Chair(s)
Hirotaka Inoue, PhD, MBA
Head, Leading Changes Office, Japan Development & Medical Affairs Division
GlaxoSmithKline K.K., Japan
Since ICH E 6 (R2) requires new responsibilities for Sponsors, each sponsor organization has to implement new measures and efforts for QMS. Although the current implementation is still trial and error at the field level, the majority of clinical trial operational staff at most companies have still not fully understood the fundamental concepts of QMS. In this session, from the standpoint of the regulatory authority, they will explain the purpose and requirements of the QMS implementation, and from the point of view of the sponsor, they will introduce the proper method for implementation using PMBOK Guide (Project Management Body of Knowledge) and others in Risk Management and Quality Management / Quality Management System (QMS)
Speaker(s)
Quality Management in a Clinical Trial - Regard to the Implementation of ICH-E6 (R2)-
Yurika Miura
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Office of Non-clinical and Clinical Compliance
Frame Work and Case Study of Clinical QMS by Using Project Management Skill
Noriaki Nagao, MPharm, PMP
JAPAN TOBACCO INC., Japan
Director, Clinical Development Dept. , Pharmaceutical Division
Quaity Tools and Skills for Clinical QMS - A Practical Application in Case Studies -
Hirotaka Inoue, PhD, MBA
GlaxoSmithKline K.K., Japan
Head, Leading Changes Office, Japan Development & Medical Affairs Division
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