Tuesday, May 25, 1:00 - 4:00 PM
PharmaSUG has always been about bringing together people from throughout our industry, and that includes the regulatory authorities with whom we collaborate. We're pleased to announce a special half-day session on Tuesday afternoon in which you'll hear directly from our colleagues at the U.S. Food and Drug Administration.
Slides from all of these presentations, plus Vaishali Popat's update on Biomedical Informatics and Safety Analytics in the Office of New Drugs, CDER/FDA on Monday afternoon from 3-3:30 PM ET, are available for download in the Conference Proceedings. Here is the complete schedule of FDA presentations for Tuesday afternoon. All times shown are U.S Eastern Daylight Time.
|1:00 - 1:20 PM||Collaborative Review of CDISC QRS Instruments||Steve Wilson, FDA CDER/OTS
Steve Kopko, CDISC
Dana Booth, CDISC
|1:20 - 1:40 PM||Updates from the Office of Biostatistics Analytics and Informatics Staff: Initiatives and Projects||Matilde Kam, FDA CDER/OTS
Xiaofeng (Tina) Wang, FDA CDER/OTS
|1:40 - 2:10 PM||Submitting Scientific Data from Different Sources||Fang Li FDA CDER/OTS|
|2:10 - 2:30 PM||Rejection Criteria (CDER & CBER)||Ethan Chen, FDA CDER/OSP|
|2:30 - 3:00 PM||CBER Update: Panel Discussion||Virginia Hussong, Wei (Lisa) Lin, Gabriela Lopez Mitnik, Jiang (Jessica) Hu, FDA CBER/OD|
|3:00 - 3:30 PM||TBA||Helena Sviglin, FDA CDER/OSP|
|3:30 - 4:00 PM||Q&A Session||All Tuesday presenters, moderated by Steve Wilson|