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Arulvathani Arudchandran, PhD

Product Quality Reviewer OBP, OPQ, CDER at FDA

Profile

Dr. Arudchandran performs product quality and immunogenicity reviews for therapeutic proteins and monoclonal antibodies. In addition, she also functions as a secondary reviewer by providing feedback to reviews performed by the staff of the division.  She received her doctorate degree in microbiology and molecular biology at Bowling Green State University of Ohio and her postdoc training at the National Institute of Health, Bethesda, Maryland. She is a member of the CDER- Office of Pharmaceutical Quality learning and professional development committee and the site visit committee that help to implement scientific, regulatory, and manufacturing learning opportunities to staff.

Agenda Sessions