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[V6-S5] The Future of Electronic Data Submission in Japan - Strategy for CDISC Correspondence
Session Chair(s)
Hironobu Saito, PhD
Specially Appointed Professor
Tottori University, Chromosome Egineering Research Center, 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)
Effective Utilization of the Electronic Study Data - Current Status and Future Perspectives in PMDA -
Hiromi Sugano, MSc
Pharmaceutical and Medical Devices Agency PMDA, Japan
Principal Reviewer for Biostatistics, Office of New Drug II
Change of In-house Strategy for Electronic Data Submission -Japan Based Company’s Perspective -
Yoshiteru Ushirogawa, MPharm
Mitsubishi Tanabe Pharma Corporation, Japan
Manager, Development Division, Data Science Department
Experience on FDA and PMDA Electronic Data Submission -Foreign Pharmaceutical Company’s Perspective <Remote Presentation via Internet>
Barrie Nelson
Nurocor, United States
Founder, SVP Digital Innovation and Chief Standards Officer
Yuki Ando, PhD
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Principal Senior Scientist for Biostatistics