CDISC Blog

CDISC European Interchange, Brussels, Belgium, 13-14 April 2011

The CDISC European Interchange has taken place in the heart of Brussels, thanks to all who attended and made it successful! More than 200 people from all over the world attended this CDISC conference in Brussels, including more than 100 attendees for the training courses on Monday, Tuesday, and Friday. The CDISC Board of Directors also held a productive meeting in Brussels on 11-12 April to discuss CDISC Strategic Aims for the next five years.

Dr. Pierre-Yves Lastic, Chair of the European CDISC Coordinating Committee (E3C), opened the Interchange with a presentation on 10 years of CDISC in Europe. It was great to see the progress CDISC has made in Europe during this past decade. Many thanks for the hard work of the E3C and CDISC Operations.

Stay tuned to the next European Interchange blogs! These will be posted over the next two weeks. And get ready for the upcoming CDISC North America Interchange in Baltimore, MD on October 10 - 14.

Please consider a sponsorship or a booth and send in your abstracts; the deadline for submission is Friday, 6 May, 2011.

Standards and the Patient - Dr Kush comments on the new stream at the North American Interchange

The second session on Thursday 4 November of the CDISC Interchange was comprised of four speakers who brought a true patient perspective and patient-oriented value to the picture of developing standards.  This session was chaired by David Handelsman of SAS, CDISC Advisory Board Representative to the Board Strategy Committee. 

FDA Presentations & Panel from the North American Interchange

One of the traditionally popular sessions of the Interchange is the FDA Panel, which took place on Thursday, 4 November, in Baltimore.  In the prior session that afternoon, chaired by CDISC Technical Architect, Dave Iberson-Hurst, presentations were made by Dr. Vicki Seyfert-Margolis, Senior Advisor of Science and Technology, Office of the Commissioner; Amy Malla (CBER);  Dr. Chuck Cooper (CDER/Computational Science Center) and Dr. Steve Wilson (Biometrics, CDER).

Final Notes from the North American Interchange by Dr. Rebecca Kush

Additional activities that took place at the Harborside during the week of 1-5 November included a meeting with FDA representatives to discuss ‘derived variables’ and how best to incorporate these into a submission, SDTM, ADaM...

CDISC Operations and Education Update from the North American Interchange by Dr. Rebecca Kush

Frank Newby, CDISC Chief Operating Officer, provided an update this year, rather than having each team leader provide a separate presentation for their team’s update.  The rationale goes like this…..