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[V3-S2] Technical and Operational Know-How for Conducting Clinical Studies under Limited Manpower
Session Chair(s)
Chie Sakanaka, MD, PhD
Vice Director, Associate Professor, Clinical Research Support Center
The University of Tokyo Hospital, Japan
This session will provide you with a forum of hints and tips for efficient operation in clinical studies in order to overcome issues and prepare for risks during the operation. To contribute to development of innovative NCE/NBEs and medical devices, cooperation among the 3 stakeholders, academia, government agencies and pharma companies are necessary. Especially, under constraints of resources, not only efficient use of time but also efficient process designs such as staff specialization and reporting/submission are required. As we are in the middle of rapid globalization, input from a speaker outside Japan will contribute to the discussions.
Speaker(s)
Challenges in Conducting Clinical Trials
Jie Willey, MSN
University of Texas, MD Anderson Cancer Center, United States
Administrative Director, Protocol Research
Toward Implementation of Investigator-Initiated Clinical Trial in Academia
Shinobu Shimizu, PhD
Nagoya Univeresity Hospital, Japan
Associate Professor, Department of Advanced Medicine
How Lilly Japan Applied Six Sigma to Improve Productivity
Souta Mizumoto, MPharm, MSc
Eli Lilly Japan K.K., Japan
Director, Global Patient Safety-Japan; Six Sigma Champion