November 9-11, 2020 | Virtual Conference


Bhagwant Rege, PhD

Division Director, Division of Immediate and Modified Release Products III (DIMRP III), OLDP, OPQ, CDER

Dr. Bhagwant Rege is the Division Director for the Division of Immediate and Modified Release Products III in CDER/OPQ/OLDP at the FDA. Prior to joining FDA in 2010, he worked at Merck & Co. for about 9 years in oral biopharmaceutics and formulation development groups. His division at FDA is responsible for collaborative evaluation and assessment of Abbreviated New Drug Applications (ANDAs) for immediate and modified release oral drug products, transdermal and topical systems, intravaginal and intrauterine systems, subcutaneous implants, and inhalation (MDI/DPI) drug products and making risk-informed recommendations on their approvability. 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), ICH Q12 Expert Working Group (EWG). 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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