September 10, 2025
CEO Noriyuki Takai Presented CRO Perspective on Japan’s FIH Guidance at PMDA‑Co‑Hosted Public Symposium
We’re honored that our CEO, Noriyuki Takai, had the opportunity to speak at the public symposium jointly hosted by PMDA, JPMA, EFPIA, and PhRMA. In his session, he shared insights from a CRO perspective on the expectations and impacts following the issuance of Japan’s notification regarding first-in-human (Phase I) clinical trials, while also addressing current challenges and future outlooks.
He also joined the panel discussion as a panelist, contributing to a dynamic exchange of perspectives with other industry leaders.
The presentation materials (in English) and symposium recording (in Japanese) are now available on the PMDA website. We invite you to explore these valuable resources at your convenience.
-PMDA website:
https://www.pmda.go.jp/review-services/symposia/0184.html
-Noriyuki Takai’s presentation materials (in English):
https://www.pmda.go.jp/files/000276891.pdf
-Noriyuki Takai’s presentation video (in Japanese):
https://www.youtube.com/watch?app=desktop&v=DjAQDCFgsGo&t=910s
(YouTube offers automatic subtitle translation.)
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