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11 Dec 2010

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...

11 Dec 2010

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).

11 Dec 2010

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. 

10 Dec 2010

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….. 

9 Dec 2010

“…..here’s the thing:   if I give my song away to 20 people and they
give it to 20 people, pretty soon they know me and my value as a creator
is dramatically enhanced.”
“The best way to raise demand for your product is to give it away.”

 

Both of these quotes, which I used to open my presentation at this
year’s North American Interchange, were from John Perry Barlow--- the first as the
lyricist for The Grateful Dead in the ‘70s and the second for Wired
Magazine in 1994.

7 Dec 2010

Dawn over the Baltimore harbor was spectacular from the Renaissance
Harborside. We are most grateful that our three keynote
speakers were willing to drive into the city while the sun was yet
rising to deliver a superb opening session to the CDISC Interchange.

2 Dec 2010

This year’s North American Interchange stood out for many as a high
quality and informative event: “The Interchange this year provided a
very positive environment.”  “The presentations were fresh and
informative.” Just a couple of the comments we heard.

16 Nov 2010

It has been a week or so since I returned from the US Interchange and I
thought it timely to write a short blog about the work that CDISC does
and, more importantly, the people who, in the words of one rather well
know sports goods manufacturer, Just Do It.

8 Oct 2010

Chris Decker writes a guest Blog about the forthcoming Round Table Discussion Groups to be held at this year's North American Interchange. He explains who should attend and the importance of your input to the CDISC standards.

24 Aug 2010

Dave Iberson-Hurst discusses the evolution of the recently released EMA guidance on electronic Source Data and the challenges associated with developing new ideas.