Associate Director for RWE at Office of Surveillance and Epidemiology, CDER
US Food and Drug Administration
Silver Spring, United States
Dr. Jie (Jenni) Li is Associate Director for Real World Evidence (RWE) at the Office of Surveillance and Epidemiology in CDER FDA, leading office activities relating to RWE matters. She oversees OSE’s scientific input into guidance and policy development for RWE. Jenni has more than 15 years research experiences in pharmacoepidemiology and clinical studies, designing and conducting observational studies using large electronic healthcare databases, national surveys and patient registries. Jenni joined FDA as an epidemiology reviewer in 2012, then worked as Team Leader, covering various therapeutic areas over the years.
Disclosure information not submitted.
Real-World Evidence (RWE) Generation for Rare Disease Drug Development and Orphan Drug Approvals
Wednesday, August 23, 2023
2:00 PM – 6:00 PM ADT