Bhagwant Rege, PhD

Division Director, Division of Biopharmaceutics, ONDP, OPQ, CDER

Dr. Bhagwant Rege is the Division Director for the Division of Biopharmaceutics in CDER/OPQ/Office of New Drug Products at the FDA. His division at FDA is responsible for assessment of clinically relevant in vitro release specifications for drug products, in vitro-in vivo correlations (IVIVC), physiologically-based biopharmaceutics models (PBBM), scientific bridging strategies, biowaivers, and BCS classification requests. Most recently he served as a division director for CDER/OPQ/OLDP/ Division of Immediate and Modified Release Products III. Prior to joining FDA in 2010, he worked in industry for many years in oral biopharmaceutics and formulation development groups. Bhagwant has served as a team leader and review chemist in the Office of Generic Drugs where he was part of the team that developed the QbD examples for the generic industry. He is a member of the FDA Emerging Technology Team (ETT) and ICH Q12 Expert/Implementation Working Group. He served as FDA liaison on the USP expert committee on dosage forms general chapter (2015-2020). Bhagwant received his BS and MS in pharmacy from the University of Mumbai, India and a Ph.D. in Pharmaceutical Sciences from the University of Maryland, Baltimore.

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