Japan CDISC Coordinating Committee Update

Japan CDISC Coordinating Committee Update

Andrea Vadakin

Director, Events and Japan Initiatives, CDISC

Join Us at the 2018 CDISC Japan Interchange

The J3C has been hard at work preparing for another informative Interchange in Tokyo. The conference will be held 9-11 July at the Ito International Research Center at Tokyo University, with the “Use of CDISC Standards in Academia” Workshop on 9 July, and the Main Conference from 10-11 July. The theme of the conference is “Ensuring and Improving Clinical Trial Quality Management Systems through Global Standards.”

The Academic Workshop will have presentations that focus on how CDISC can be utilized by academia in Japan. The PMDA and AMED will present on regulatory expectations and offer helpful approaches for implementing CDISC standards. Researchers will share the challenges, value, use cases and review processes of using CDISC standards.

During the Main Conference, Dr. Takuhiro Yamaguchi, Professor, Division of Biostatistics, Tohoku University Graduate School of Medicine, and Director, Clinical Research Data Center, Tohoku University Hospital, will provide the Keynote Presentation “Quality Management Systems and CDISC Standards in Clinical Research in Japan” on 10 July. The Main Conference will also feature presentations and updates by representatives from the U.S. FDA, PMDA and AMED. CDISC leadership and Board representatives will also be present to provide updates on the standards and answer attendees’ questions during the conference.

Time is limited to plan your participation; register today! We hope to see you at the conference.