FIRST QUARTER 2016


PMDA, and U.S. FDA have been invited to speak, in addition to an array of distinguished speakers who will be presenting about their latest experiences with CDISC standards during the Interchange in Vienna.


The E3C assists in the creation of new user networks that endorse and encourage the implementation of CDISC standards throughout Europe. Two CDISC user networks were recently formed through the support of E3C members. The CDISC Italian User Network was recently re-initiated and announced during the CDISC Day in Milan in September 2015, and the Polish User Network was initiated during the CDISC Day in Warsaw, Poland in February 2016. The committee ensures that feedback from local user networks is communicated back into the CDISC organization


through the CDISC Executive Operations team.


Special thanks to our E3C members as they dedicate time from their busy schedules to endorse and support CDISC in Europe:


• Andrea Rauch, Boehringer Ingelheim • Angelo Tinazzi, Cytel* • Daniel Graham, Astrazeneca* • •


Joerg Dillert, Oracle


Jozef Aerts, University of Applied Sciences FH Joanneum


• Mark Lambrecht, SAS • Peter Van Reusel, Business and Decision •


Pierre-Yves Lastic, Sanofi


• Sofie Inari Castella, Novo Nordisk* *Newly-elected members of the E3C.


Update from the Japan CDISC Coordinating Committee


Andrea Vadakin, Director, CDISC Communications & Public Relations


Even though we are only at the start of the year, it has quickly become apparent that 2016 will be a year of tremendous growth and collaboration in Japan. The CDISC J3C began the year by holding elections, and six nominees were officially added, two from industry, and four from academia: 1. Kaoru Matsumi, CMIC, Co., Ltd. 2. Dr. Shiro Hinotsu, Okayama University Hospital 3. Dr. Toshiki Saito, Nagoya Medical Center 4. Dr. Takuhiro Yamaguchi, Tohoku University Hospital


5. Katsuhiko Yoshimoto, Nippon Shinyaku Co., Ltd. 6. Dr. Hideto Yokoi, Kagawa University Hospital


These elections tie in well to another recent, major initiative of the J3C - a project to translate SDTM v1.4 and SDTM IG v3.2 into Japanese. The first project of its kind, this initiative brings together stakeholders from industry, academia, the Japanese regulatory authority (PMDA), and CDISC, all with the goal of ensuring a standard process for translating CDISC standards documentation into the Japanese language. Stay tuned for more announcements as this initiative moves forward.


It is important to note that this is the year that the Japan PMDA will begin to require submissions of electronic data


in CDISC standard format, beginning 01


October 2016. To view the Technical Notification, Q&A, and Conformance Guide, please visit the CDISC website here for links to the PMDA website. This will also be a leading topic at the upcoming 2016 CDISC Japan Interchange, to be held 02-03 June 2016 in Tokyo. Representatives from the PMDA will be on- site offering presentations and participating in panel discussions, so please plan your participation early to ensure that you are part of the conversation!


CDISC CDIS CDI C WEBSIT LINK WEBSITE LINK 15


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