11th May 2018

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Maximizing the Benefits from PhUSE WG Activities and Deliverables – From Emerging Trends & Technologies to eData Submission



As a once-a-year single day event in Tokyo, this SDE will feature PhUSE Working Group activities and deliverables covering entire drug development from start to finish, with particular focus on regulatory submission in Japan. We will hear about WG activities and recent deliverables from not only Japanese industry speakers but also presenters from the global PhUSE organization, as well as advances in electronic study data submission in Japan from a regulatory perspective.

We hope this SDE will further encourage Japanese PhUSE members to participate in and contribute to PhUSE WG activities so that PhUSE can be a true global collaboration platform for everyone within the pharmaceutical industry and regulatory.



SAS Institute Japan
Roppongi Hills Mori Tower 11F 6-10-1 Roppongi 
Tokyo 106-6111



9.30 – 10:00 Registration  
10.00 – 10.05 Welcome & Opening Remarks Azusa Tsukida,
10.05 – 10.45 PhUSE Working Group Introduction

Ian Fleming,
Medidata & WG Lead for Emerging Trends & Technologies and Educating for the Future

10.45 – 11:30 PMDA Update Yuki Ando,
11.30 – 12.45 Lunch & Networking Sponsor Presentations:
DOT World, CAC CROIT & Takumi Information Technology
12.45 – 13.15 SUGCDSC: Filling Gaps between Knowledge and Practice Venu Perla,
13.15 – 13.45 CJUG SDTM Team - AI Updates Hajime Shimizu,
13.45 – 14.15 Introduction to the TAUG SDTM Mapping Index Yoshito Koujin,
14.15 – 14.45  Networking Sponsor Presentations:
SAS Japan, A2 Healthcare & SNBL-PPD
14.45 – 15.30 Afternoon Break
15.30 – 16.00 PhUSE Working Groups - SDTM ADaM Implementation FAQ / Optimizing the Use of Data Standards) Yoshiko Kitagawa,
Working Group Participant &
Koichi Yamaguchi,
Eli Lilly Japan K.K.
16.00 – 16.30 PhUSE Global Updates and Review Stephen Bamford,
PhUSE Global Events Director
16.30 – 17.30 Panel Discussion Panelists
17.30 – 17.40 Closing Remarks Motohide Nishi,
 Medidata & Yoshiteru Chiba, UMIN


SDE Chair:

Azusa Tsukida, Sanofi

SDE Co-Chairs:

Motohide Nishi, Medidata Solutions

Yamaguchi Koichi, Eli Lilly

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




If you are interested in sponsoring this event, click here.



Grand Hyatt Tokyo

Candeo Hotels Tokyo Roppongi


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