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[Session 5]eData Submission 2020 and Beyond
Session Chair(s)
Yasuharu Shibata, MSc
Head of Clinical Data Management, Cliinical Data Management
MSD K.K., Japan
Electric data submission will be mandatory from April 2020. This session will provide the opportunity to re-confirm “The Basic Principles on Electronic Submission of Study Data for New Drug Applications” and its updated information, in addition the aspect of project management to prepare for Electric Data submission and experiences for data submission. The session will provide the opportunity to consider how to contribute from data manage and discussion how to practice to 2020 and beyond.
Speaker(s)
Yuki Ando, PhD
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Principal Senior Scientist for Biostatistics
Project Management and Regulatory interactions Regarding CDISC
Yutaka Noguchi, MSc
Daiichi Sankyo Co., Ltd., Japan
Manager, Oncology Clinical Development Department
The Experience of the Electronic Submission to PMDA from the Construction of Clinical Data Package to NDA
Masahiro Kojima
Kyowa Hakko Kirin Co., Ltd., Japan
Takayoshi Ichikawa
Daiichi Sankyo Co., Ltd., Japan