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. |
Location
Gilead Sciences
362 Lakeside Drive
Foster City, CA 94404
Time
Wednesday, October 8, 2014
12:00 - 4:00 PM (PDT)