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OpenCDISC Live San Francisco

Pinnacle 21

Wednesday, October 8, 2014 from 12:00 PM to 4:00 PM (PDT)

OpenCDISC Live San Francisco

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RSVP Ended Free  

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Event Details

OpenCDISC Live is making its way to the San Francisco Bay Area for the West Coast swing of our 2014 tour! Enjoy this opportunity to meet the developers of OpenCDISC face-to-face, ask questions, collaborate and learn.

In our first West Coast 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
12:45pm Introduction to OpenCDISC Live Forum
  Max Kanevsky, OpenCDISC
  OpenCDISC Past, Present, and Future
1:05pm FDA JumpStart for the Modern Review Process
  Max Kanevsky, OpenCDISC
  Learn about the new FDA Modern Review Process, JumpStart, DataFit, and why you should care.
1:25pm Common Data Issues in FDA submissions
  Sergiy Sirichenko, OpenCDISC
  Learn about the common issues plaguing FDA submission data and how they impact FDA's ability to use modern review tools and processes. Sergiy Sirichenko will share his experience working as FDA Data Fitness Analyst and recommend how to identfiy and fix issues to ensure high-quality standard submissions.
2:10pm Then and Now: FDA’s Changing Expectations about Data and Documentation
  John Brega, PharmaStat
  The past two years have seen a sea change in the conversation at FDA about submission data and documentation. The Review Divisions routinely make pre-NDA requests for standard data and new documentation formats. John Brega will share PharmaStat’s experiences in recent conversations and negotiations with the FDA.
2:40pm Break
2:55pm Demonstration of OpenCDISC Enterprise
  Travis Collopy, Pinnacle 21
  See a demonstration of OpenCDISC Enterprise features, including the new Define.xml v2.0 creation tool.
3:40pm Upcoming release of OpenCDISC Community 2.0
  Max Kanevsky, OpenCDISC
  Learn about the upcoming release of OpenCDISC Community v2.0, including major upgrades to the Validator, an introduction to Define.xml Designer, and much more.


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