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Tokyo Big Sight

2018 年 11 月 11 日 9:30 上午 - 2018 年 11 月 13 日 5:40 下午

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

15th DIA Japan Annual Meeting 2018

Innovative technologies such as AI, big data/genomics, and cell/gene therapies are poised to transform healthcare product development across the globe – join us to discuss these topics.

[V3-S2] Technical and Operational Know-How for Conducting Clinical Studies under Limited Manpower

Session Chair(s)

Chie  Sakanaka, MD, PhD

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)

Jie  Willey, MSN

Challenges in Conducting Clinical Trials

Jie Willey, MSN

University of Texas, MD Anderson Cancer Center, United States

Administrative Director, Protocol Research

Shinobu  Shimizu, PhD

Toward Implementation of Investigator-Initiated Clinical Trial in Academia

Shinobu Shimizu, PhD

Nagoya Univeresity Hospital, Japan

Associate Professor, Department of Advanced Medicine

Souta  Mizumoto, MPharm, MSc

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

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