Thanks to all who attended the first OpenCDISC Live Forum in Boston, MA!
This inaugural CDISC and FDA educational event was a resounding success. Topics covered included the challenges and opportunities presented by JumpStart, DataFit, and the modern FDA approval process.
Pinnacle 21 proudly introduces OpenCDISC Live!
This series of events will travel across the U.S., throughout 2014 and beyond. They will provide time and space for pharmaceutical and biotech professionals to meet with the developers of OpenCDISC, learn what’s coming from the FDA and CDISC, ask questions, collaborate and learn.
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.
We're pleased to announce the availability of OpenCDISC Validator 1.5.
Download OpenCDISC Validator 1.5 here
Registration is open for the next meeting, scheduled for April 17, 2014 from 1-5pm. The meeting will be hosted by Celgene at their Summit site. Web conferencing will also be available. Please register by Wednesday, April 9. The link to register: https://www.survey-expert.com/surveyIndex.asp?U=8000008002105027347
Meeting agenda:
See you there!
The next meeting of the NJ CDISC Users Group will be held the afternoon of April 17, 2014 at Celgene in Summit. If you are interested in presenting at the meeting, please contact Patricia Majcher at patricia.majcher@novartis.com by March 7. Presentations should be no more than 20 minutes long (excluding time for Q&A). Any CDISC-related topic is welcome. We look forward to hearing from you!
Registration is now open for the January 14, 2014 meeting. The meeting will be held from 1-5pm at Sanofi, 55 Corporate Drive (Room B-1121), Bridgewater, NJ. Web conferencing will also be available. Please register by Monday, January 6. The link to register: https://www.survey-expert.com/surveyIndex.asp?U=1009002005108017393
Meeting agenda:
See you there!
The next meeting of the NJ CDISC Users Group will be held the afternoon of January 14, 2014 at Sanofi in Bridgewater, NJ. If you are interested in presenting at the meeting, please contact Pei Lee Tien by November 8. Her email address is pei.tien@novartis.com. Presentations should be no more than 20 minutes long (excluding time for Q&A). Any CDISC-related topic is welcome. We look forward to hearing from you!
We're pleased to announce the availability of OpenCDISC Validator 1.4.1.
Download OpenCDISC Validator 1.4.1 here
For a complete list of validation rule changes please refer to the release notes or review the latest rules posted on OpenCDISC Validation Rules Repository.
The next meeting of the New Jersey CDISC User Group will be held the afternoon of Thursday, September 19, at Merck in Summit. Web conferencing will be available. The agenda for the meeting is as follows:
Please register by Friday, September 13, using the link below:
NJ CDISC User Group Registration >
See you there!