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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

[V6-S4] Introduction of eTMF in Japan

Session Chair(s)

Mitsuo  Hayashi, MSc, RPh

Mitsuo Hayashi, MSc, RPh

Director & Head, Clinical Enablement

MSD K.K., Japan

Yukihiro  Matsuda, MSc

Yukihiro Matsuda, MSc

Director, Clinical Delivery

ICON Clinical Research GK, Japan

Since much drug development is carried out in Multi-Regional Clinical Trials, the eTMF is essential to efficient inspection preparation and readiness. However, there some are problems in introducing the eTMF in Japan that cannot be solved by individual companies who use the conventional “Mokuroku” catalog for the management of essential documents. How do we fill the gap between the eTMF and “Mokuroku” catalog? Is it necessary to submit the original documents for inspection? This session will introduce the purpose and framework of eTMF, one company’s inspection experience, and government and industry perspectives on introducing the eTMF in Japan.

Speaker(s)

Kohei  Suzuki

Purpose of eTMF, and Computer System and Project Structure Necessary for eTMF

Kohei Suzuki

Veeva Japan K.K., Japan

Senior Sales Consultant, R&D Vault

Kiyoko  Matsushima

Inspection Readiness and Preparation using eTMF for PMDA Inspection

Kiyoko Matsushima

Pfizer R&D, Japan

Manager, Development Operations

Hiroshi  Hamada

Hiroshi Hamada

Takeda Pharmaceutical Company Limited, Japan

Manager, Clinical Coordination Group, Development Operations Department

Tatsuo  Kishi, PhD

Tatsuo Kishi, PhD

Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Deputy Director, Office of Non-clinical and Clinical Compliace

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