11th May 2018

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



The 2018 Japan SDE was held on May 11th at SAS Institute Japan in Roppongi City, Tokyo. The theme of this event focused on maximizing the benefits from PHUSE Working Group activities, which attracted more than 120 attendees from various biopharmaceutical and CRO companies in Japan. Speaking at this event were Ms. Yuki Ando from the PMDA, the global PHUSE organization, and the CDISC Japan User group, with presentations on advances in electronic study data submission in Japan and advances in new technology adoption. The day concluded with group discussions covering SDRG, ADRG, Define-XML/ARM, data anonymization, legacy data conversion, and challenges in academia. This excellent event was successful because of the contributions from our sponsors, Co-Chairs, speakers, the PHUSE Office and the Organizing Committee. Thanks to all who volunteered at and attended this event.



Welcome & Opening Remarks – Azusa Tsukida, Sanofi

PHUSE Working Group Introduction –  Ian Fleming, Medidata & WG Lead for Emerging Trends & Technologies and Educating for the Future

PMDA Update – Yuki Ando, PMDA

CJUG SDTM Team - AI Updates – Hajime Shimizu, CJUG SDTM

Introduction to the TAUG SDTM Mapping Index – Yoshito Koujin,  JPMA DS TF1

PHUSE Working Groups - SDTM ADaM Implementation FAQ / Optimizing the Use of Data Standards – Yoshiko Kitagawa, Working Group Participant & Koichi Yamaguchi,  Eli Lilly

PHUSE Working Group Acitivity Introduction - Clinical Legacy Data Conversion Plan and Report – Koichi Yamaguchi,  Eli Lilly

PHUSE Global Updates and Review – Stephen Bamford, PHUSE Global Events Director


View the event brochure.






Photos of the day:


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