Speakers

Dr. Rakhi Shah has been with the FDA since 2004, serving as a research scientist, senior reviewer, team lead, branch chief, associate director for regulatory affairs prior to her current role as associate director for science and communication in OPMA. She provides staff leadership and direction in assessment of manufacturing and facilities for A/NDAs and BLAs, and supplements including inspections to support applications action. She has a Ph.D. in pharmaceutical sciences, M.S. in Bioprocess technology and B.S. in Pharmaceutical Sciences.