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Tokyo Big Sight

Nov 13, 2016 9:30 AM - Nov 15, 2016 5:30 PM

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

13th DIA Japan Annual Meeting 2016

[V4-S4] Practice of Project Management Process on Clinical Research Activities Planned and Conducted by Medical Institutes

Session Chair(s)

Yoko  Kazami, RPh, PMP

Yoko Kazami, RPh, PMP

Director, Regulatory Affairs

Nobelpharma Co., Ltd., Japan

To improve the efficiency and effectiveness of medical product development, the pharmaceutical industry has used project management (PM) methods. Yet, at present, a systematic implementation of PM methods has not yet been established due to a lack of experience and insufficient learning opportunities for project managers, principal investigators and medical organization staff, especially in the area of Investigator-Initiated Study (IIS). However, in the many cases of IIS where there are a lack of staff and funding, effective utilization of PM methods is one measure that can be used to facilitate operations. This session will introduce real examples of implementing PM methods by those involved in IIS, including issues requiring attention at the point of introduction and increased potential future applications of PM methods.

Speaker(s)

Kayoko  Kikuchi, PhD

Utilization of Simplified Project Management Plan

Kayoko Kikuchi, PhD

Fujita Health University, Japan

Development Office for Translational Research

Hirofumi  Tsuboi, MS

Project Management Techniques Introduced in the Ethics Review System Restructuring

Hirofumi Tsuboi, MS

Shiga University of Medical Science Hospital, Japan

Center for Clinical Research and Advanced Medicine

Yoshio  Marumoto, MD, PhD

Our Experience of Project Management Methods for Clinical Research Support

Yoshio Marumoto, MD, PhD

Yamaguchi University Hospital, Japan

Associate Professor

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