Japan User Group - Team Activities and Regulatory Reminder

Japan User Group - Team Activities and Regulatory Reminder

Yoshiteru Chiba

Head of CDISC Japan User Group

CJUG held a webinar workshop 1 December 2019 with 79 attendees. Webinar workshops are always a great opportunity to share team activities and achievements.

CDISC Foundational Standards were covered with Imasho Masaaki(MSD K.K.) providing a CDASH team update, Akira Soma (Oracle) delivering a presentation on SDTM titled "Legacy Data Conversion Q&A" and Jun Atsumi (Toray Industries, Inc.) presenting "Examination of ADaM Corresponding to Specific Analysis Requirements."

Additionally, Yasunobu Furukawa (Kyowa Kirin Co., Ltd.) delivered a presentation on "Electronic Data Creation for Pharmacokinetic Analysis" and Hiroaki Fukuda(MSD K.K.) addressed "Examination of Electronic Data Submission Method when Recurrent Event Data is Analyzed.”

We would also like to remind the CDISC community that the transition period for the PMDA’s e-submission requirements will end 31 March 2020. CJUG looks forward to the e-submission requirements taking effect into accelerate clinical research, increase quality, reduce cost, and develop good medicine for all patients.

It’s been another active and engaging year for CJUG. We look forward to much of the same in 2020.