Tokyo, Japan

For Successful Electronic Data Submission

                                                                                                                                                                                        

Summary:

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.

Presentations:

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 ADaMPanellists: Takuhiro Yamaguchi, Kota Ono, Taku Sakaue, Yuta Sakakibara, Akira Kurisu & Yasutaka Moriguchi

 

Download the event brochure.

 

SDE Chairs:

If you have any questions, or require any information, please contact the SDE Co-Chair.

Yochiteru Chiba, UMIN

Motohide Nishi, Medidata

 

Sponsors:

           

                 

                   

          

 

 

 

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