Back to Agenda
[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, PMP
Director, Project Management, Linical Co., Ltd., 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
Senior Sales Consultant, R&D Vault, Veeva Japan K.K., Japan
Purpose of eTMF, and Computer System and Project Structure Necessary for eTMF
Kiyoko Matsushima
Manager, Development Operations, Pfizer R&D, Japan
Inspection Readiness and Preparation using eTMF for PMDA Inspection
Hiroshi Hamada
Manager, Clinical Coordination Group, Development Operations Department, Takeda Pharmaceutical Company Limited, Japan
Tatsuo Kishi, PHD
Deputy Director, Office of Non-clinical and Clinical Compliace, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Have an account?