PharmaSUG Single Day Event
PharmaSUG will be hosting a Single Day Event (SDE) with a focus on sharing solutions of e-submissions.
Agenda
| 7:30-9:30 AM | Hot Breakfast | |
| 8:00-9:30 AM | Registration | |
| 8:30-8:45 AM | Welcome from Co-Chairs | Margaret Hung and Matt Becker |
| 8:45-9:15 AM | Advanced Visualization Using TIBCO Spotfire and SAS Using SDTM Data | Ajay Gupta, PPD |
| 9:15-9:45 AM | Simplify and Streamline Using Python | Michael Stackhouse, Covance |
| 9:45-10:15 AM | Streamlining the Metadata Management Process Using SAS Life Science Analytics Framework | Alex Ford, SAS |
| 10:15-10:45 AM | Refreshment Break | |
| 10:45-11:15 AM | ADaM 2018: What's New and What's Coming | Jack Shostak, DCRI and Sandra Minjoe, PRA |
| 11:15-11:45 AM | ADaM Structures for Integration: A Preview | Wayne Zhong, Accretion Softworks |
| 12:00-1:00 PM | Lunch | |
| 1:00-1:30 PM | A Framework for Implementing [Conflicting] FDA Guidance | Todd Case, Vertex Pharmaceuticals |
| 1:30-2:00 PM | Preparing ADaM Datasets and Related Files for FDA Submission | Ragini Hari and Sandra Minjoe, PRA |
| 2:00-2:30 PM | Define XML Expectations from Various Clients, Tools and Industry Groups | Gustav Bernard and Zach Dorman, IQVIA |
| 2:30-3:00 PM | Refreshment Break | |
| 3:00-3:30 PM | CDISC Standards: Evolving to Meet Submission Needs | Diane Wold, CDISC |
| 3:30-4:00 PM | Study Data Topics at FDA/CDER | Sara Jimenez, FDA/CDER |
| 4:00-4:45 PM | Takeaway Messages from Speakers | |
| 4:45-5:00 PM | Closing Session and Raffle Drawing (gift cards and other prizes) |
Registration
Online registration ends October 22, 2018.
More Information
For more information, contact:
Matt Becker or Margaret Hung
nc2018sde@pharmasug.org
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NCBiotech
15 T.W. Alexander Drive
Research Triangle Park, NC 27709
$75