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ON DEMAND - New Drugs Regulatory Program Modernization
Session Chair(s)
Kevin Bugin, PhD, MS, RAC
Deputy Director of Operations, Office of New Drugs, CDER
FDA, United States
The New Drugs Regulatory Program is undergoing a modernization. Leaders of the modernization will share their vision for the New Drugs Regulatory Program, the strategic objectives of modernization, and updates on key initiatives.
Learning Objective : Recognize the objectives and goals of the New Drugs Regulatory Program Modernization; Define the implications of the modernization process on new drug review and regulation activities.
Speaker(s)
Impetus for and Vision of the New Drugs Regulatory Program Modernization
Janet Woodcock, MD
United States
Retired, Principal Deputy Commissioner, FDA
Strategic Objectives of the New Drugs Regulatory Program Modernization
Peter P. Stein, MD
FDA, United States
Director, Office of New Drugs, CDER
Impact of the New Drugs Regulatory Program Modernization on the Office of New Drugs and Public Health
Khushboo Sharma, MBA
Accumulus Synergy, United States
Chief Regulatory Innovation Officer
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