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[Session 6] Moving Forward to Start Electronic Submission
Session Chair(s)
Yosuke Kobayashi
Section Chief, Department of Clinical Research and Trials
Japan Agency for Medical Research and Development (AMED), Japan
Yasuharu Shibata, MSc
Head of Clinical Data Management, Cliinical Data Management
MSD K.K., Japan
Over the past few years, regulatory agencies and pharmaceutical companies have been discussing preparation of electronic submissions, which PMDA began to accept in October 2016. In advance of these electronic submissions, the gateway portal system pilot resulted in updated technical conformance guidance in June 2016. Now that the process and guidelines have taken form, this session will reconfirm these requirements and discuss best practices based on that system pilot experience.
Speaker(s)
Preparation for Using the Gateway System and Key Points to be Considered
Tatsuya Nakagawa
MSD K.K., Japan
Experience of Electronic Study Data Submission
Takuma Oda
Janssen Pharmaceutical K.K., Japan
Director, Local Safety Office
Considerations on Electronic Study Data Submission for Phase I and Clinical Pharmacology Studies
Yohei Takanami, MS
Takeda Pharmaceutical Company Limited, Japan
Manager
PMDA Update on Advanced Review with Electronic Data
Yuki Ando, PhD
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Principal Senior Scientist for Biostatistics
Naruhiko Hiramoto
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Director for Information System Coordination
Yumiko Asami
Boehringer Ingelheim, Japan
Chapter Head of Clinical Data Science
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