.jpg "Qi Liu, PhD photo")
Associate Director for Innovation & Partnership, Office of Clinical Pharmacology
US Food and Drug Administration
Dr. Qi Liu is the Associate Director for Innovation & Partnership in the Office of Clinical Pharmacology (OCP), CDER, FDA. During her career at the FDA, Qi contributed to over 200 NDA/sNDA reviews, 20 BLA/sBLA reviews, and numerous IND reviews to support drug development. Qi has also worked on many research projects and built collaborations to advance regulatory sciences and promote innovations. She co-authored approximately 50 manuscripts and presented on many topics at FDA Advisory Committee meetings and scientific conferences. She worked on several working groups for FDA guidance documents and Manual of Policies & Procedures (MAPP) development. She also leads OCP’s Innovative Data Analytics program and OCP Machine Learning Review Team. Qi is a Fellow of the American College of Clinical Pharmacology. She is also on the editorial board of the American Association of Pharmaceutical Scientists Journal, Clinical Pharmacology and Therapeutics, and of Clinical and Translational Science. Qi is interested in the application of clinical pharmacology principles, innovative tools (e.g., modeling/simulation, machine learning, mobile technology), big data and real-world evidence to facilitate drug development and advance precision medicine.
Before joining FDA, Qi was a senior pharmacokineticist at Merck & Co. Inc. She obtained her Ph.D. degree in Pharmaceutics and a concurrent Master's degree in Statistics from the University of Florida. In addition, Qi has a Master's degree in Pharmaceutics and a Bachelors’ degree in Clinical Pharmacy from West China University of Medical Sciences.
Disclosure information not submitted.
Monday, January 10, 2022
4:30 PM – 5:30 PM ET
Friday, March 18, 2022
1:15 PM – 2:15 PM ET
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