OpenCDISC Live comes to New Jersey

August 6, 2014

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.

Eventbrite - OpenCDISC Live New Jersey

Agenda

12:00pm Networking and Lunch
1:00pm Introduction to OpenCDISC Live Forum
  Max Kanevsky, OpenCDISC
  OpenCDISC Past, Present, and Future
1:20pm 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
1:40pm Using OpenCDISC to prepare for FDA submissions
  Sergiy Sirichenko, OpenCDISC
  Learn about the new FDA Study Data Technical Conformance Guide and what it’s telling us about validation and the use of OpenCDISC. We’ll also review the most common OpenCDISC messages and how to handle them.
2:10pm SDRG from template to submission document
  Jacques Lanoue, Novartis
  See a case study of how Novartis implemented a process to produce an informative Study Data Reviewer’s Guide (SDRG) to support a successful submission of SDTM data to FDA.
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
  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.

Location

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

Time

Tuesday, September 9th, 2014
12:00 - 4:00 PM (EDT)

Sponsored by

Novartis