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OpenCDISC Live New Jersey

Pinnacle 21

Tuesday, September 9, 2014 from 12:00 PM to 4:00 PM (EDT)

OpenCDISC Live New Jersey

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Event Details

OpenCDISC Live is making its way to North Jersey for the second stop on our 2014 tour!
Enjoy this opportunity to meet the developers of OpenCDISC face-to-face,
ask questions, collaborate and learn

In our second Forum, we'll be discussing how to prepare for the new FDA JumpStart and DataFit processes. We'll also give you an in-depth look at OpenCDISC Enterprise and show you how its new advancements can assist the process.


12:00pm Networking and Lunch
1:00pm Introduction to OpenCDISC Live Forum
  Max Kanevsky, OpenCDISC
1:20pm FDA JumpStart for the Modern Review Process
  Max Kanevsky, OpenCDISC
1:40pm Using OpenCDISC to prepare for FDA submissions
  Sergiy Sirichenko, OpenCDISC
2:10pm SDRG from template to submission document
  Jacques Lanoue, Novartis
2:40pm Break
2:55pm Demonstration of OpenCDISC Enterprise
  Travis Collopy, Pinnacle 21
3:40pm Upcoming release of OpenCDISC Community 2.0
  Max Kanevsky, OpenCDISC


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Have questions about OpenCDISC Live New Jersey? Contact Pinnacle 21

When & Where

Novartis Pharmaceuticals
200 West Village Promenade, Auditorium
Ridgedale Avenue / One Health Plaza
East Hanover, NJ 07936

Tuesday, September 9, 2014 from 12:00 PM to 4:00 PM (EDT)

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