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. |
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)