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[V6-S4] Introduction of eTMF in Japan
Session Chair(s)
Mitsuo Hayashi, MSC, RPH
Director & Head, Clinical Enablement
MSD K.K., Japan
Yukihiro Matsuda, MSC
Director of Project Management
Linical Japan, 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)
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
Inspection Readiness and Preparation using eTMF for PMDA Inspection
Kiyoko Matsushima
Pfizer R&D, Japan
Manager, Development Operations
Hiroshi Hamada
Takeda Pharmaceutical Company Limited, Japan
Manager, Clinical Coordination Group, Development Operations Department
Tatsuo Kishi, PHD
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Deputy Director, Office of Non-clinical and Clinical Compliace