PharmaSUG Single Day Event

PharmaSUG will be hosting a Single Day Event (SDE) with a focus on sharing solutions of e-submissions.


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)


Online registration ends October 22, 2018.


More Information

For more information, contact:

Matt Becker or Margaret Hung


15 T.W. Alexander Drive
Research Triangle Park, NC 27709