Speakers

Elisa Nickum, PhD, PMP, is a Senior Regulatory Business Process Manager in the Office of Program and Regulatory Operations within the Office of Pharmaceutical Quality in the Center for Drug Evaluation and Research at the U.S. FDA. Her office focuses on cross-functional project management for various regulatory programs and business process initiatives, and she serves as a project manager in support of the Emerging Technology Program, PDUFA VII Commitments, the 2022 Omnibus Appropriations Bill, and work related to Nitrosamine Impurities in Drug Products. Prior to her current role, Elisa served as a Chemistry Reviewer in the OPQ Office of Lifecycle Drug Products. Elisa joined FDA in 2002 as an analytical chemist at the Forensic Chemistry Center in the Office of Regulatory Affairs. She earned her PhD in analytical chemistry at the University of Cincinnati and a BS in forensic chemistry at Ohio University.