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.

Eventbrite - OpenCDISC Live Boston


Monday June 9th, 12-4 pm


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
  Meet the developers of OpenCDISC face-to-face, ask questions, share your stories and how we can improve our products


Biogen Idec
15 Cambridge Center, Building 8
Cambridge, MA 02142

Sponsored by: