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Thursday, June 18 • 5:00pm - 6:00pm
#547 OD: ON DEMAND - New Drugs Regulatory Program Modernization

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Component Type: Forum
Level: Basic

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 Objectives

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.

Chair

Kevin Bugin, PhD, MS, RAC

Speaker

Impetus for and Vision of the New Drugs Regulatory Program Modernization
Janet Woodcock, MD

Strategic Objectives of the New Drugs Regulatory Program Modernization
Peter P. Stein, MD

Impact of the New Drugs Regulatory Program Modernization on the Office of New Drugs and Public Health
Khushboo Sharma, MBA



Speakers
avatar for Kevin Bugin

Kevin Bugin

Director of Special Programs, Office of New Drugs, CDER, FDA
Kevin Bugin works for the FDA in the Office of New Drugs as the Director of Special Programs, leading various internally driven initiatives for the enhancement of the new drugs regulatory program. Prior to joining the FDA, Kevin Bugin worked in both industry and government in multiple... Read More →
avatar for Khushboo Sharma

Khushboo Sharma

Deputy Director for Operations, Office of New Drugs, CDER, FDA
Khushboo Sharma is the OND Deputy Director for Operations in CDER's Office of New Drugs. In this role, Khushboo has oversight of business processes and staff providing key support for regulatory review and oversight of resource capacity planning including staffing for OND. Khushboo... Read More →
avatar for Peter Stein

Peter Stein

Director, Office of New Drugs, CDER, FDA
Peter Stein, M.D., is the Director of CDER’s Office of New Drugs (OND). OND is responsible for the regulatory oversight of investigational studies during drug development and decisions regarding marketing approval for new (innovator or non-generic) drugs, including decisions related... Read More →
avatar for Janet Woodcock

Janet Woodcock

Acting Commissioner, FDA, United States
Dr. Janet Woodcock began her long and distinguished FDA career in 1986. In 1994, Dr. Woodcock was named Director of the CDER, overseeing the center’s work that is the world’s gold standard for drug approval and safety. In that position, she has led many of the FDA’s groundbreaking... Read More →


Thursday June 18, 2020 5:00pm - 6:00pm EDT
TBD Virtual Event Horsham, PA 19044
  09: Regulatory, Forum