Tokyo, Japan

10th December 2019

Registration will open in November.

 All PHUSE Single Day Events are FREE to members. To become a member click here. Registrations per company are limited to 20% of maximum attendance.



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



Regulators, industries and academia have been very interested in how to use Real-world Data (RWD) in clinical development. Database research using RWD is also actively being considered in Japan. How we can better leverage existing RWD to improve the costs and efficiencies of research and development will be discussed.
Electronic data submission (eSubmission) in Japan will be mandatory from April 2020. We will invite panellists from experienced and non-experienced companies on eSubmission and conduct a round table discussion. Practical and operational challenges will be discussed for full implementation of eSubmission in 2020. The new era of Japan "REIWA" began on 1 May 2019. In the new era, we will revitalise PHUSE Working Groups activities in Japan to support industry transformation.



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



To follow


SDE Chairs:

Takashi Kitahara, Novartis

Yosuke Nishida, Chugai Pharmaceutical

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




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