November 8-10, 2021 | Virtual Conference

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Speakers

Larisa Wu, PhD

Acting Associate Director of Science and Communication, Office of New Drug Products, OPQ, CDER
FDA

Larisa Wu, Ph.D., is the ONDP Associate Director for Science and Communication (acting). Prior to ONDP, she was in OPQ Immediate Office where she served as Special Assistant to OPQ Deputy Director since OPQ stood up in 2015. Since she joined FDA in 2011, Larisa contributed significantly to various initiatives that became pivotal to the launch of OPQ, including integrated team-based quality assessment, risk-based review, and ANDA backlog review and management. In her most recent roles, Larisa worked extensively on several FDA, CDER, and OPQ initiatives including: Knowledge-aided Assessment and Structured Application (KASA), Concept of Operations (ConOps) for Inspection of Human Drugs, Process and Facility Integration, OPQ Secondary Assessment, and BARDA-FDA Drug Shortage Program. Her contributions have been recognized in award ceremonies at the agency, center, and office level. Larisa received her Ph.D. degree in Bioengineering from University of Utah, followed by a postdoctoral fellowship in Pharmaceutical Sciences at University of Maryland, School of Pharmacy. She also holds an M.S. degree in Chemistry and a B.S. degree in Biomedical Engineering.

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