November 8-10, 2021 | Virtual Conference

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Speakers

Dhaval Gaglani, MS

Branch Chief, Division of Immediate and Modified Release Products III, Office of Lifecycle Drug Products, OPQ, CDER
FDA

Dhaval Gaglani is the Branch Chief in the Office of Lifecycle Drug Products within the Office of Pharmaceutical Quality at the FDA. At his current position, he oversees quality assessment for immediate and modified release oral drug products, including inhalation drug products, inhalation aerosols (MDIs) and inhalation powders (DPIs). His job responsibilities also include assessing drug product quality aspects and responding to Controlled Correspondence (CC) and Pre-ANDA meeting requests for complex drug-device combination products. He is also currently serving as a member of several Inhalation product working groups including: FDA draft MDI/DPI CMC Guidance Revision and GDUFA related Inhalation Research. Prior to joining FDA in 2010, he worked at Wyeth/Pfizer for about 10 years in product development and commercial manufacturing.

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