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Tokyo Big Sight

Nov 13, 2016 9:30 AM - Nov 15, 2016 5:30 PM

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

13th DIA Japan Annual Meeting 2016

[V7-S3] Efficient Utilization of Disease Registry Data in Drug Development

Session Chair(s)

Satoshi  Teramukai, PhD

Satoshi Teramukai, PhD

Professor, Department of Biostatistics

Kyoto Prefectural University of Medicine, Japan

Efficient utilization of disease registry (or cohort) data is of current interest to streamline drug development, especially for rare diseases. We can use this data as historical data when planning a trial design or evaluating the efficacy and safety of an investigational drug. The PMDA has also examined the potential utility of disease registry data for New Drug Applications. This session will discuss issues concerning utilization of disease registry data in drug development, including case studies.

Speaker(s)

Kazuhito  Shiosakai

Expectation for the Disease Registry Data from a Pharmaceutical Company

Kazuhito Shiosakai

Daiichi Sankyo Company, Limited, Japan

Manager, Statistical Analysis Group, Biostatistics & Data Management Department

Akihiro  Hirakawa, PhD

Promoting Eficiency of Drug Development Using Disease Registry Data

Akihiro Hirakawa, PhD

Tokyo Medical and Dental University, Japan

Professor,Clinical Biostatistics,Graduate School of Medical and Dental Sciences

Akiko  Hori, MD, PhD

PMDA Perspective:Utilization of the Disease Registry Data for Drug Development

Akiko Hori, MD, PhD

Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Review Director, Office of Regulatory Science

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