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[V4-S4] Practice of Project Management Process on Clinical Research Activities Planned and Conducted by Medical Institutes
Session Chair(s)
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
Development Office for Translational Research, Fujita Health University, Japan
Utilization of Simplified Project Management Plan
Hirofumi Tsuboi, MS
Center for Clinical Research and Advanced Medicine, Shiga University of Medical Science Hospital, Japan
Project Management Techniques Introduced in the Ethics Review System Restructuring
Yoshio Marumoto, MD, PhD
Associate Professor, Yamaguchi University Hospital, Japan
Our Experience of Project Management Methods for Clinical Research Support