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Session 6 / Venue 4: Toward Utilization of CDISC Standards at J-NDA Submission - Part 2
Session Chair(s)
Hidetoshi Misawa
Senior Manager, Clinical Data Integration and Operations Group 1
Pfizer Japan Inc., Japan
Yasunori Yoshida
Food Safety Commission of Japan
Cabinet Office, Government of Japan, Japan
FDA has utilized submitted data in CDISC format and plans to mandate the CDISC data submission for all sponsors. It is expected that, by utilizing CDISC data, the J-NDA reviews and consultation meetings would become more efficient and regulatory science studies using accumulated data would be activated, e.g., modeling and simulation. “Japan Revitalization Strategy -JAPAN is BACK-”, which states Eliminate Lag by 2020, was approved in a Cabinet meeting on June 14, 2013. The Strategy for Health and Medical Care states “PMDA should actively work on analyses and research of clinical data and construct more sound and efficient evaluation/decision processes at the review and the consultations. “ To achieve these goals, it becomes increasingly important for every stakeholder to use CDISC standards in Japan as well. Because CDISC standards are the unique global standards, Japanese data in CDSIC format would contribute to global health and medical care. This session will provide presentations by PMDA, industry, CDISC community in Japan and ARO, and discuss on current situations, a future direction, and challenges.
Speaker(s)
Overview of CDISC SDTM (Study Data Tabulation Model)
Taku Shimizu
Quintiles Transnational Japan K.K., Japan
DM
Overview of CDISC ADaM (Analysis Data Model)
Yumiko Asami
Boehringer Ingelheim, Japan
Chapter Head of Clinical Data Science
Experience in Preparing Clinical Data Submission to the FDA
Satoru Tsuchiya, MSc
JPMA (Japan Pharmaceutical Manufacturers Association)/Sumitomo Pharma, Co., Ltd., Japan
Senior Director, Global Data Design Office
From ARO’s Perspective
Norihiro Sato, MD, PhD
Hokkaido University Hospital, Japan
Vice Chair, ARO Council
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