Blog

OpenCDISC Live Boston

May 6, 2014

Welcome to the first ever OpenCDISC Live Forum - a series of events where you can meet the developers of
OpenCDISC face-to-face, ask questions, collaborate and learn.

In our first 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 Validator 1.5 and show you how it's new advancements
can assist the process.

Date/Time:

Monday June 9th, 12-4 pm

Agenda:

12:00pm	Networking and Lunch
1:00pm	Introduction to OpenCDISC Live Forum
	Max Kanevsky, OpenCDISC
	OpenCDISC Past, Present, and Future
1:15pm	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
1:30pm	Getting the most out of OpenCDISC Validator
	Majdoub Haloui, Biogen Idec Sergiy Sirichenko, OpenCDISC
	Review best practices for configuring OpenCDISC Validator, including setting up and updating MedDRA and CDISC Controlled Terminology, and improving performance. Learn how to run OpenCDISC Validator from CLI, SAS, USB, and on Macs. And learn how to analyze and interpret OpenCDISC reports.
2:00pm	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.
2:20pm	Break
2:35pm	How OpenCDISC Enterprise improved our process and compliance
	Tina Casteris, Biogen Idec
	See a case study of how Biogen Idec has implemented OpenCDISC solutions to improve the processes for CDISC compliance and FDA submissions
2:55pm	Demonstration of OpenCDISC Enterprise
	Travis Collopy, Pinnacle 21
3:15pm	Live Forum Discussion
	Everyone
	Meet the developers of OpenCDISC face-to-face, ask questions, share your stories and how we can improve our products