Speakers

Dr. Bhagwant Rege is the Division Director for Biopharmaceutics in CDER/OPQ/OPQA I 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), physiologicallybased biopharmaceutics models (PBBM), scientific bridging strategies, biowaivers, and BCS classification requests. Prior to his current position, he served as a Division Director for CDER/OPQ/OLDP/ Division of Immediate and Modified Release Products III. Before joining the 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 PhD in Pharmaceutical Sciences from the University of Maryland, Baltimore.