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Tokyo Big Sight

Nov 15, 2015 9:30 AM - Nov 17, 2015 5:45 PM

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

12th Annual Meeting DIA Japan 2015

The registrants will have access to presentation PDFs through Tuesday, May 17, 2016.

[V6-S2] Contributions of Statistics and Behavior Observation to Drug and Medical Device Development

Session Chair(s)

Yoichi M.  Ito, PhD

Yoichi M. Ito, PhD

Director, Hokkaido University Hospital, Institute of Health Science Innovation, Japan

Recently, big data has been in the news, and a new type of job for statisticians, called data scientists, has been created. However, in the pharmaceutical company, due to the influence of ICH E9, there are many trial statisticians. In other fields, business improvements due to a qualitative method called Behavior Observation are attracting attention. The ease of use of the product is directly linked to it being properly used or not. By the Behavior Observation you can discover needs that even the users weren’t aware of, making it possible to really improve the user friendliness of medical products and devices. At this session, we will look back on the contribution of ICH E9 to the current development of medical products and devices, as well as explore the potential contribution of statistics and behavior observation to the future of medical product and device development.

Speaker(s)

Tosiya Shun Sato, PhD

Tosiya Shun Sato, PhD

Professor, Department of Biostatistics, Kyoto University School of Public Health, Japan

ICH E9 Statistics Guideline: Before & After

Hiromu  Nishiuchi, MS

Hiromu Nishiuchi, MS

Co-founder, Data Vehicle, Inc., Japan

How Private Sectors Can Generate Value from Statistics

Takafumi  Koshino

Takafumi Koshino

Principal Researcher, OGIS-RI Co.,Ltd., Japan

Innovation Starts from Deep Understanding of Behavior Contexts - “Behavior Observation” Method, Deriving Potential and Essential Insight

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