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Radisson Blu Plaza Hotel

Dec 14, 2023 9:00 AM - Dec 15, 2023 5:00 PM

Hyderabad Banjara Hills, 8-2-409, Rd No. 6, Banjara Hills,, Hyderabad 500034, India

DIA-US FDA-ANDA WORKSHOP: Present And Future Perspectives On Generic Drug Life Cycle Management

Session 5: Knowledge-Aided Assessment and Structured Application (KASA)

Speaker(s)

Peter  Capella, PHD

Peter Capella, PHD

Director, Division of Immediate and Modified Release Drug Products, Office of, Lifecycle Drug Products, Office of Pharmaceutical Quality, CDER, FDA , United States

Sharmista  Chatterjee, PHD

Sharmista Chatterjee, PHD

Division Director in Division of Pharmaceutical Manufacturing II,, Office of Pharmaceutical Manufacturing Assessment (OPMA), OPQ/CDER, FDA, United States

Aditi S Thakur

Aditi S Thakur

Senior Pharmaceutical Assessor, Office of Pharmaceutical Manufacturing Assessmen, t, Office of Pharmaceutical Quality, CDER, FDA, United States

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