Speakers

Dr. Yanira Gonzalez-Berrios is a Senior Chemist in the Division of Product Quality Assessment VII (DPQA-VII) within the Office of Product Quality Assessment II (OPQA-II)/Office of Pharmaceutical Quality (OPQ) at the Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA). Dr. Gonzalez-Berrios is responsible for monitoring the lifecycle of generic drug products through the collaborative evaluation and quality assessment of ANDAs and their supplements. She also reviews controlled correspondence and participates in guidance development. Dr. Gonzalez-Berrios has been a quality reviewer with the FDA for more than 11 years. Prior to joining OPQ as a quality reviewer, she was an ORISE postdoctoral research fellow at the Office of Biotechnology Products. She earned a Ph.D. in Biochemistry and Molecular Biology from Baylor College of Medicine and a B.S. in Chemistry from the University of Puerto Rico.