I am very keen to attend the OpenCDISC Live but unable to travel from Japan to Boston on June 9th. Do you have any plan to allow remote users to get involved in this event?
Thanks,
-Ebi
The presentation slides are available at Open CDISC Live: Boston — Recap | Pinnacle 21
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 |
Location:
Biogen Idec
15 Cambridge Center, Building 8
Cambridge, MA 02142