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) |
| 10:00-10:30AM | Advancing Premarket Safety Analytics | Dr. Yang Veronica Pei Chief Medical Officer CDER OND ODES DBIRBD |
| 10:30-11:00AM | OCS Update: OCS Clinical Services & the Traceability Assessment | Jesse Anderson Lead Project Manager CDER OTS OCS DRRR |
| 11:00-11:30AM | FDA’s Study Data Policy Framework and How CDISC Properties Are Evaluated for Inclusion | Helena Sviglin Program Management Officer CDER OSP DSS |
| 11:30AM-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
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