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[SESSION 6] Data Management in Investigator-Initiated Clinical Trials and Clinical Researches
Session Chair(s)
Akimitsu Ikeura, MSc
Associate Director, Data Management Group, Biostatistics & Data Management Dept.
Daiichi Sankyo Co., Ltd., Japan
Kyoko Minamoto
Medical Technologist
National Cancer Center, Japan
After the Pharmaceutical Affairs Law was revised in 2003, investigators and pharma-ceutical companies could plan and conduct clinical trials themselves. In the fifteen years since passed, compliance with CDISC and other international standards has become indispensable, and individual investigators have increasingly needed to secure funds and other resources from external sources. It is now expected that academic clinical research will be effected by the new Act on Clinical Studies published in April 2017. This session will discuss anticipated developments impacting investigator-initiated clinical trials in academia.
Speaker(s)
Data Management in Pharma and Academia: Big Data Convergence for Bridging Clinical, Regulatory, and Commercialization
David Kiger
Biofourmis, United States
VP, Business Development
Clinical Data Management in Academia and Pharmaceutical Industry
Mikio Mori
National Cancer Center Hospital, Japan
Section Head, Data Management Section, Data Management Division,
SEPECIAL LECTURE 2: New Act on Clinical Studies (tentative)
Yasuhiro Fujiwara, MD, PhD
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Chief Executive
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