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東京ビッグサイト | 有明

2018年11月11日 (日) 午前 9:30 - 2018年11月13日 (火) 午後 5:40

〒135-0063, 東京都江東区有明3-11-1



[V7-S1] Implementing Quality Management System (QMS) in Your Trials and Understanding the Purpose and Concept

Session Chair(s)

Hirotaka  Inoue, PhD, MBA

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)


Yurika  Miura

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

Noriaki  Nagao, MPharm, PMP

Frame Work and Case Study of Clinical QMS by Using Project Management Skill

Noriaki Nagao, MPharm, PMP


Pharmaceutical Division,Clinical Development Dept.

Hirotaka  Inoue, PhD, MBA

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