Blog

OpenCDISC Live comes to San Francisco

September 10, 2014

OpenCDISC Live is making its way to the San Francisco Bay Area for the West Coast swing of our 2014 tour!
Enjoy this opportunity to meet the creators of OpenCDISC face-to-face, ask questions, collaborate and learn.

In our first West Coast 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
12:45pm	Introduction to OpenCDISC Live Forum
	Max Kanevsky, OpenCDISC
	OpenCDISC Past, Present, and Future
1:05pm	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.
1:25pm	Common Data Issues in FDA submissions
	Sergiy Sirichenko, OpenCDISC
	Learn about the common issues plaguing FDA submission data and how they impact FDA's ability to use modern review tools and processes. Sergiy Sirichenko will share his experience working as FDA Data Fitness Analyst and recommend how to identfiy and fix issues to ensure high-quality standard submissions.
2:10pm	Then and Now: FDA’s Changing Expectations about Data and Documentation
	John Brega, PharmaStat
	The past two years have seen a sea change in the conversation at FDA about submission data and documentation. The Review Divisions routinely make pre-NDA requests for standard data and new documentation formats. John Brega will share PharmaStat’s experiences in recent conversations and negotiations with the FDA.
2:40pm	Break
2:55pm	Demonstration of OpenCDISC Enterprise
	Travis Collopy, Pinnacle 21
	See a demonstration of OpenCDISC Enterprise features, including the new Define.xml v2.0 creation tool.
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.