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 two special presentation blocks on Tuesday afternoon and Wednesday morning in which you'll hear directly from our colleagues at CDISC and the U.S. Food and Drug Administration.

Tuesday Afternoon, 1:30-3:20 PM, LoneStar B-C

Time Presentation Title Speaker(s)
1:30 - 2:20 PM CORE Status and Next Steps Anthony Chow, CDISC
2:30 - 3:20 PM CORE, A Community-Driven Solution Charles Shaidle, CDISC

Wednesday Morning, 10:00 AM - 12:00 PM, LoneStar B-C

Time Presentation Title Speaker(s)
10:00 - 10:15 AM FDA CDER Office of Biostatistics: A PDUFA VII and FDA Initiatives Update Maria Matilde S. Kam, Ph.D., FDA CDER
10:15 - 10:30 AM FDA Study Data Technical Rejection Criteria (TRC): What You Need to Know! Jiang Xu, FDA CDER
10:30 - 10:45 AM TBA Helena Sviglin, FDA CDER
10:45 - 11:00 AM TBA Steve Wilson, FDA CDER
11:00 - 11:15 AM CDISC Updates from the SDS QRS Subteam Dana Booth, CDISC
11:15 - 11:30 AM TBA Dave Evans, CDISC
11:30 - 11:50 AM Q&A All Panelists