For Successful Electronic Data Submission
The Tokyo SDE took place on 14th April 2017 at SAS Institute Japan with over 120 attendees. Presenters shared their experiences of e-submission and the associated issues faced among sponsors, CROs, IT vendors and the PMDA were discussed.
Welcome and Opening Remarks – Motohide Nishi, Medidata Solutions
PHUSE Activities Worldwide – US CSS 2017 Report – Koichi Yamaguchi, Eli Lilly Japan
PMDA Update – Yuki Ando, PMDA
PHUSE Working Group Updates:
– Optimizing the USE of Data Standards Working Group – Jane Lozano, Eli Lilly
– Standard Analyses and Code Sharing Working Group – Mary Nilsson, Eli Lilly
Perspectives on the Past, Present and Future of CFAST Therapeutic Area Data Standards Development – John Neville, Critical Path Institute
The Experience of PMDA Pilot Project for Utilization of Electronic Data and Standardization of Clinical Research Operation at Tohoko University Hospital Clinical Research Center – Takuhiro Yamaguchi, Tohoku University
Issues and Challenges between SDTM and ADaM – Kota Ono, Hokkaido University
ADaM & Analysis Specific to Oncology – Taku Sakaue, Chugai Pharmaceutical
Collaboration Across Clinical and Nonclincal Team Members to Implement CDISC Standards – Yuta Sakakibara, Kyowa Hakko Kirin
Panel Discussion: How to Handle Issues and Challenges Between SDTM and ADaM – Panellists: Takuhiro Yamaguchi, Kota Ono, Taku Sakaue, Yuta Sakakibara, Akira Kurisu & Yasutaka Moriguchi
Download the event brochure.
If you have any questions, or require any information, please contact the SDE Co-Chair.
Yochiteru Chiba, UMIN
Motohide Nishi, Medidata