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 presentation block on Wednesday morning in which you'll hear directly from our colleagues at the U.S. Food and Drug Administration.
Wednesday, May 17, 2023, 10:00 AM - Noon - Golden Gate 6-8
| Time | Presentation Title | Speaker(s) |
| 10:00 - 10:30 AM | Advancing Premarket Safety Analytics | Dr. Yang Veronica Pei Chief Medical Officer CDER OND ODES DBIRBD |
| 10:30 - 11:00 AM | OCS Update: OCS Clinical Services & the Traceability Assessment | Jesse Anderson Lead Project Manager CDER OTS OCS DRRR |
| 11:00 - 11:30 AM | FDA’s Study Data Policy Framework and How CDISC Properties Are Evaluated for Inclusion | Helena Sviglin Program Management Officer CDER OSP DSS |
| 11:30 AM - Noon | Experiences of CDER Statistical Analysts with NDA/BLA Reviews: Some Helpful Tips for Sponsors | Liping Sun Statistician CDER OTS OB DAI |
Speakers
 Jesse Anderson Lead Project Manager CDER OTS OCS DRRR alt="" />/td> |  Dr. Yang Veronica Pei Chief Medical Officer CDER OND ODES DBIRBD |
 Liping Sun Statistician CDER OTS OB DAI |
 Helena Sviglin Program Management Officer CDER OSP DSS |