2027 SOUSEIKAI IRB SCHEDULE UPDATE
SOUSEIKAI’S 2027 IRB Schedule is now available. For more information, please see Schedule tab h e r e.
News
Notice of Change of Executive Director at SOUSEIKAI
As of June 1st, 2026, SOUSEIKAI’s Executive Director has changed from Dr. Shin Irie, to Dr. Akinori Urae. Please see the linked document for your reference: Notice of Change of Executive Director at SOUSEIKAI_20260601
Three Approaches to Accessing the Japanese Market
An informative article in ASCPT’s Clinical and Translational Science from NOVARTIS was recently published, analyzing three approaches to accessing the Japanese market: the Japanese Phase I waiver, the first-in-human study conducted in Japan, and multifunctional Japanese Phase I studies. “Reimagining Early-Phase Clinical Development in Japan: From Regulatory Obligation to Global Acceleration” Further analysis of cycle times emphasizes Japan’s globally competitive timelines, as “a key location for first-in-human and early phase trials.” For those interested in...
PMDA Symposium RE: Phase 1 Trial Inclusion Guidance
On August 4th the PMDA held an Online Symposium, addressing the updated guidance of the implementation of Phase 1 trials in Japanese subjects prior to international joint trial inclusion. There was a record of over 2,600 attendees, and mention of the contents of the symposium to be offered in an English version at a later date. For those of you not fluent in Japanese but have an AI assistant handy to translate, you are welcome...
DIA Global Annual Meeting – Washington D.C.
Excited to joing this year’s #DIA2025 Anual Global Meeting, June 15-19th. With industry leaders gathering to tackle key challenges in healthcare, it promises to be a good one. If you are in the area or joining the event, please stop by our booth, # 1607! Lots to discuss regarding approaches on how to include or specifically target the Japanese Market.
IRB Schedule Update (2025~2026)
Our 2025~2026 IRB Schedule has been updated! Please see here for the most current IRB schedule dates.
WORLD VACCINE CONGRESS 2025 – WASHINGTON, D.C.
We will be attending the upcoming World Vaccine Congress in Washington DC, from April 21st – 24th. Looking forward to sharing about our vaccine capabilities, and learning about the newest developments in the industry. Please feel free to drop by if you are in the area (booth #603) !
JSCPT CONFERENCE – SAITAMA
We will be both in attendance and exhibiting at this year’s Japanese Society of Clinical Pharmacology and Therapeutics (JSCPT) in Saitama (Omiya Sonic City) from 12/13 (Fri) ~12/14 (Sat). This is a great opportunity to see what research developments are ongoing here, targeting the Japanese Market. https://www.congre.co.jp/jscpt2024/
TIDES EUROPE CONFERENCE – HAMBURG
Come join us this year for the TIDES (Oligonucleotides) Europe Conference, taking place in Hamburg, Germany, from November 12th-14th! Say hi at booth # 404!! #TIDESEUROPE
FESTIVAL OF BIOLOGICS CONFERENCE – BASEL
SOUSEIKAI is exhibiting at the Festival of Biologics Basel 2024 on 15-17 October! Join us at Europe’s Largest Biologics Event covering the start-to-finish of biologic drug development. We’re excited to extend an exclusive invitation to register: https://i.snoball.it/p/kDrY/l/1 #festofbiologics