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Virtual Event

Jun 14, 2020 9:00 AM - Jun 18, 2020 5:00 PM

(Eastern Standard Time)

Fort Washington, PA 19034

DIA 2020 Global Annual Meeting

ON DEMAND - New Drugs Regulatory Program Modernization

Session Chair(s)

Kevin  Bugin, PhD, MS, RAC

Kevin Bugin, PhD, MS, RAC

Associate Vice President, Global Regulatory Policy

Amgen, 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)

Janet  Woodcock, MD

Impetus for and Vision of the New Drugs Regulatory Program Modernization

Janet Woodcock, MD

United States

Retired, Principal Deputy Commissioner, FDA

Peter P. Stein, MD

Strategic Objectives of the New Drugs Regulatory Program Modernization

Peter P. Stein, MD

FDA, United States

Director, Office of New Drugs, CDER

Khushboo  Sharma, MBA

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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