Jie (Jenni) Li, PhD

Associate Director for RWE
FDA CDER Office of Surveillance and Epidemiology
Silver Spring, Maryland, United States

Dr. Jie (Jenni) Li has more than 15 years research experiences in pharmacoepidemiology and clinical studies. She is a Associate Director for RWE in the Office of Surveillance and Epidemiology at CDER FDA, overseeing RWE review, research and policy, with in-depth knowledge in drug safety and effectiveness studies. Her expertise lie in evaluating real-world evidence, designing and conducting observational studies using large electronic healthcare databases, national surveys and patient registries.

Disclosure information not submitted.

Presentation(s):

• Using Real-World Evidence to Support the FDA Regulatory Approval: Methodological Considerations

  Friday, November 4, 2022
  8:00 AM – 9:30 AM ET

• 2 - Key Considerations for Evaluating Real-World Evidence in Support of FDA Regulatory Decision-Making

  Friday, November 4, 2022
  8:00 AM – 9:30 AM ET