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[S31] Do you manage quality of the clinical trial for whom ? - What We Can Do for Patients -
Session Chair(s)
Noriko Kobayashi
Senior Clinical Research Coordinator, Clinical Research Support Office
National Cancer Center Hospital, Japan
The development of a Quality Management System (QMS) is currently under consideration in the conduct of clinical trials, but the emphasis is on ensuring the reliability of the trial results. Moreover, the use of tools for implementing QMS and compliance with the newly examined Quality Management (QM) procedures themselves appear to be objectives. However, in the conduct of clinical trials, protection of human subjects is also essential, so it is necessary to consider what QM means, including human subject protection. To this end, it is important for pharmaceutical companies and medical institutions to share the goal of the clinical trial that should be achieved and for both parties to aim for the same goal of the clinical trial. In this session, we would like to consider ways to ensure that patients can participate in clinical trials with peace of mind and that it is safe and appropriate by reviewing current problems in clinical trials and considering how pharmaceutical companies and medical institutions can work together
Speaker(s)
What Doctors (Investigators) Can Do for Patients?
Toshio Shimizu, MD, PhD
National Cancer Center Hospital, Japan
Head of Physician (Oncology Phase 1 Unit), Dept of Experimental Therapeutics
What CRCs Can Do for Patients?
Junko Yamasaki
Kobe University Hospital, Clinical & Translational Research Center, Japan
CRC
What CRAs Can Do for Patients
Takashi Asahi
CMIC Co., Ltd., Japan
Head of Department, Project Management Dept.
What Sponsors Can Do for Patients?
Noriaki Nagao, MPharm, PMP
JAPAN TOBACCO INC., Japan
Director, Clinical Development Dept. , Pharmaceutical Division
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