FIRST QUARTER 2016 CDISC AROUND THE GLOBE


Updates from our CDISC Coordinating Committees (3Cs) and User Groups around the globe can be found in this section.


French-Speaking User Network Update Simon Lebeau, CDISC Nutritional Data Standards Therapeutic Area Team Member, and Data Manager, Data & Information Management, Danone


The CDISC French-Speaking User Group event was held in Paris on 02 February 2016, hosted and sponsored by Danone Research and Medidata at Paris Marriott Hotel. There were 186 registrations, the highest in the network’s history.


The conference was introduced by X. Gobert (Business & Decision Life Sciences), who leads the French committee, and S. Auger (Danone Research), who explained why Danone is engaged in the CDISC community.


The last session was dedicated to a participative workshop around the topic “SDTM mapping using ODM.”


There were some very interesting comments and interactions


from the presentations. The attendees


participants also


regarding the shared useful


information regarding the issues they face in their daily jobs.


Thanks to all of our presenters P-Y. Lastic (Sanofi), A. Lismond (SGS LSS), N. De Donder (Business & Decision Life Sciences), J. Miguet (Danone Research), J. Mambrini & F. Wager (Servier), F. Kussener (SAS Institute), S. Lebeau & G. Neveu (Danone Research), M. Nouira (Medidata).


It is worth mentioning that in September last year, the first Swiss event took place in Geneva (hosted by SAS®) and was already a big success. The user community is becoming more and more diversified and includes not only members from the pharma industry but also people from academic institutions, nutrition, agriculture, hospitals and with a wide range of profiles.


The next meeting will take place in September 2016 (date TBD). The committee will discuss this soon and provide more information in the coming months.


European CDISC Coordinating


Committee Updates Diana Harakeh, CDISC Director, Alliances Development


P-Y. Lastic (Sanofi & Past-Chair of the CDISC Board) provided a general update on the CDISC standards and activities. Then, the attendees enjoyed several presentations sharing experiences and best practices related to the implementation of the CDISC standards and demonstrating their added value in the clinical research process.


The European CDISC Coordinating Committee (E3C) continues to be a vital support for the CDISC organization in Europe by broadening its outreach and planning for annual events in various European regions. The


committee recently elected


3 new


members, and currently includes 9 total participants who are dedicated to support CDISC and its mission in their local regions. The E3C has been heavily involved in planning and organizing for the CDISC Europe Interchange that will be held on 25-29 April 2016 in Vienna, Austria. E3C members met in Geneva, Switzerland on 13 and 14 January where they evaluated the 2016 Interchange abstracts and drafted the program of this event. Regulators from EMA,


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