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 |