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[V6-S5] The Future of Electronic Data Submission in Japan - Strategy for CDISC Correspondence
Session Chair(s)
Hironobu Saito, PhD
Corporate Advisor, Daiichi Sankyo Co., Ltd., Japan
In Japan, the defined procedure for electronic data submission compliant with CDISC standards was provided according to a released guidance in April. In addition, the plans for the PMDA gateway portal system for electronic data submission have become clear recently. In this session, approaches and issues for system implementation both in the health authority and in industry will be shared, and the nextgeneration review process using electronic data will be discussed. Assuming not only Japan submission but also global submission, strategy for CDISC correspondence considering the differences in guidance between Japan and US will become increasingly important.
Speaker(s)
Hiromi Sugano, MSc
Principal Reviewer for Biostatistics, Office of New Drug II , Pharmaceutical and Medical Devices Agency PMDA, Japan
Effective Utilization of the Electronic Study Data - Current Status and Future Perspectives in PMDA -
Yoshiteru Ushirogawa, MPharm
Manager, Development Division, Data Science Department, Mitsubishi Tanabe Pharma Corporation, Japan
Change of In-house Strategy for Electronic Data Submission -Japan Based Company’s Perspective -
Barrie Nelson
Founder, SVP Digital Innovation and Chief Standards Officer, Nurocor, United States
Experience on FDA and PMDA Electronic Data Submission -Foreign Pharmaceutical Company’s Perspective <Remote Presentation via Internet>
Yuki Ando, PhD
Principal Senior Scientist for Biostatistics, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
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