Partner and User Group Events

 

CDISC Bay Area User Network Meeting

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Location: South San Francisco Conference Center, 255 South Airport Blvd in South San Francisco, CA

Date: 30 April 2015

Time: 12:30 - 16:30

 

Please reserve Thursday, April 30 from 12:30 - 4:30 for a meeting of the Bay Area CDISC Network at the South San Francisco Conference Center (see directions below).  Presentations will start at 1:00.

 

You won’t want to miss this one!  Our first two presenters are from FDA.

 

Ron Fitzmartin was a co-author of the new Guidances on electronic submissions, which establish the framework and start the clock for requiring standardized data in submissions.  He will explain how the Guidances and specifications work, how they relate to each other, and how to determine the effective dates of requirements for your studies.  Lilliam Rosario, Director of the Office of Computational Sciences, will talk about CDER’s JumpStart program, a service to modernize regulatory review by implementing standards-based processes and software tools to aid review.

 

It’s hard to overstate the importance of these developments for those of us in the trenches, planning our next submissions.  The Guidances are making CDISC standards a requirement, and JumpStart is already making them indispensable to reviewers.

 

Many thanks to Genentech and to TalentMine for co-hosting the meeting at the Conference Center, and to Dave D’Attilio (TalentMine) and Patricia Gerend (Genentech) for persuading their management to underwrite it.  Thanks also to Sandra Minjoe (Accenture) for helping to make it happen.

 

If you plan to attend, please contact jbrega@pharmastat.com so we can get an accurate count for planning purposes. Also, please forward this invitation to your colleagues and friends.

 

We’re leaving extra time in this meeting for people to chat with colleagues and catch up on news from other companies.  It’s been a while since our last meeting and a lot has changed in the meantime.  We encourage you to come to the Conference Center early to find parking and start your networking.  The room will be open at noon and the first presentation will start promptly at 1:00.

 

If you cannot attend in person, you have the option of joining our web conference.  Ron and Lilliam will be presenting by web conference, the other presentations will be live at the Conference Center.  To attend the web conference, please email jbrega@pharmastat.com so we can send you the login information.  Please ask for the web conference info so we can respond appropriately.

 

Click here for more information about the meeting topics, directions and further details.

 

 

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