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E-Newsletter July 2010

Newsletters are posted as they are released, so check regularly for the latest edition.

 

 

With thanks to our Benefactors.

 

Welcome to the July newsletter.

Welcome to the latest CDISC Newsletter. This month we focus on forthcoming CDISC training and events, news from the FDA CDER & CBER and the latest CDISC Terminology developments.

If you have any comments or would like to contribute an article to the CDISC Newsletter, please contact AJ de Montjoie.

 

CDISC and the FDA

There has been much discussion over recent weeks about the new FDA CDER standards implementation plan Dr. Rebecca Kush has written an informative Blog about these latest releases from FDA. In addition, CDISC produced a Webinar, Key Messages from CDISC and FDA that you can now find on the website. This includes CDER and CBER representatives (Chuck Cooper and Amy Malla) who presented and discussed their Standards Implementation Plans and provided up-to-date information for those planning eSubmissions to these FDA centers. This webinar is now archived but you can still access and purchase the webinar here.

 

Not Reading our Blog? Make sure you read the latest news!

CDISC will be using the Blog to communicate more directly with our community. CDISC Blog articles are posted regularly and bring the most up to date news from CDISC operations. Read the latest about CDISC SHARE, CDISC Collaborations with the Critical Path Institute and Terminology.

 

New CDISC Journal

CDISC is launching a journal at the end of the year and we would welcome articles from all our members about the way they are currently using CDISC Standards. We are also offering opportunities for people to advertise in the Journal. If you would like to contribute an article to our first journal or find out more details of the advertising opportunities, please contact AJ de Montjoie.

 

China Meetings in Asia 

CDISC will be highlighted in a number of meetings in Asia this month.  The Korean CDISC Coordinating Committee (K3C), under the leadership of Dr. Sukil Kim, has organized meetings with the KFDA and a Symposium in Seoul, Korea for 12 July.   CDISC will be holding the inaugural meeting of the CDISC China Expert Group on 16 July in Beijing.  This will be a small meeting comprised of high-level individuals (based upon recommendations of the CDISC Advisory Board), from organizations that support CDISC and wish to encourage adoption of a global clinical research standard in China.  (The C3C is planning the second CDISC China Interchange in September in Shanghai.)  The J3C, under the leadership of Dr. Yoshio Tsukada, has organized CDISC training and the Japan Interchange for 20-23 July.   Dr. Rebecca Kush will be accompanied at these events by the E3C leader and long-time Board member, Dr. Pierre-Yves Lastic.  Watch for news on these events on the CDISC blog and twitter.

 

Trial Design Examples for Members Only!

Recently the Trial Design Team has updated the materials available to members on the CDISC website. You can read more details of the posting in this short article and find all the examples from the Team here.

 

CDISC PhUSE Memorandum of Understanding

CDISC is pleased to announce a new MOU with PhUSE which establishes a mutually beneficial relationship. So you can expect to see some new events on our Non-CDISC Events pages and we hope to see articles from PhUSE members submitted to the CDISC newsletters.

 

User Group Meetings

Meetings:

  • Bay Area CDISC Implementation Network, 15 July 2010 from 1:30 to 4:30 at Jazz Pharmaceuticals on Porter Drive in Palo Alto. Full Details and Agenda

Don't forget that there are materials from many of the User Groups posted on the CDISC Portals.