Blog

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.

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.