CDISC Blog

The CDISC Asia activities continued with the Japan CDISC Interchange the week of 20-23 June.  The Interchange itself was 20-21 June followed by two days with courses (SDTM, Protocol Representation, CDASH, ADaM).  The J3C members are pros at this by now; it was their sixth Interchange and they demonstrated once again their organizational skills and thorough understanding of CDISC and its standards.  Leaders Drs. Yoshio Tsukada, Hiroshi Azuma and Kiyoteru Takenouchi and the other six J3C members executed the meeting flawlessly.  They also had presentations by the CDISC Japan User Groupson their activities around various standards, including CDASH.  They have translated the CDISC Primer into Japanese and a copy was provided to each Interchange attendee.  An awards ceremony honored outstanding service from two J3C members at the reception on 20 July. A J3C dinner, which included instructors and leaders from K3C and Global CDISC, took place on the evening after the Interchange. The conference itself had one track so that everyone was able to hear all of the excellent presentations, and simultaneous translation was made available.  Speakers included representatives of MHLW, Hamamatsu University, UMIN, JPMA and many companies, global and Japanese.

The leaders of the J3C, C3C, K3C and CCAC have all expressed a willingness and interest in working more closely together around CDISC initiatives in Asia. 

(See slide above with a view from Japan on how they are organized to collaborate.)

Representatives from the Philippines, Taiwan and other countries participated in these events – more this year than any other year in Japan.  Three key interest areas are a) streamlining the way clinical research is done (both at academic institutions and for biopharmaceutical product development); b) educating locally on CDISC standards to prepare for eSubmissions to FDA; c) garnering interest in Asia for government and regulatory authorities to adopt the global CDISC standards for clinical research—linking to healthcare to improve safety and patient safety and well-being.