Tokyo, Japan

10th December 2019

REIWA: Real-world Evidence and Electronic Submission Inspired from PHUSE Working Groups Activities


The 7th PHUSE Single Day Event in Japan was held on 10th December 2019 and mainly focussed on Real-world Evidence (RWE) and electronic data submission in Japan. There were attendees from pharmaceutical companies, CROs, IT vendors and the PMDA.

Mr Yosuke Nishida, Chugai Pharmaceutical (SDE Chair), facilitated the RWE session, and discussions were made from technical and scientific aspects. Ms Yuki Ando, PMDA, gave us an update on the acceptance and use of electronic data at the PMDA. Takashi Kitahara, Novartis Pharma (SDE Chair), facilitated the panel discussions on addressing common questions in the industry. Finally, group discussions including all participants took place. Potential challenges of, and topics on, electronic data submission, RWE, and open-source technology were identified for the start of Working Groups activities in Japan next year.

We are grateful to all SDE committee members, presenters, panellists, facilitators, and sponsors of this event who provided their expertise and contributions!



Real-world Data Processing with Open-source Tools and Standards – Masafumi Okada,

Handling Big Data Using SAS (HPDS2, HASH Object and FCMP) – Do Not Sort! Reduce Steps! – Yutaka Morioka,
 EPS Corporation

Data-driven Drug Development Using a Development-related Data Platform Including Real-world Data – Collaborate with Biostatisticians, Data Scientists and Data Managers with “Yaritainen” Passion! – Takamichi Baba,
 Shionogi & Co.

Planning of Post-marketing Database Studies Using MID-NET – Yosuke Fujii, Pfizer

Electronic Data Submission in Japan – Yuki Ando, PMDA
To follow.

e-Data Submission Uncertainties from a Less-experienced Point of View – Takeyuki Shindo, Meiji Seika Pharma

e-Data Submission Tips and Insights from More-experienced Point of ViewTomotaro Shiraishi,
 A2 Healthcare Corporation


View the event brochure.





Photos of the day:


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