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Session Chair(s)
Brian Mayhew, MA, MBA
Executive Director, Regulatory Policy
Novartis Pharmaceuticals Corporation, United States
Learning Objective : Discuss background information and key elements of the New Molecular Entity Review Program including why was it established and how it works; Describe FDA's implementation of the program to date; Identify key issues that may be considered to improve the program.
Speaker(s)
Status Update: An FDA Perspective
Beth Duvall Goldstein
FDA, United States
Science Policy Analyst, ONDP, OND, CDER
Industry Perspective
Deepika Jalota, PHARMD
PMV Pharmaceuticals, United States
Chief Regulatory and Quality Officer
Panelist
Kate Rawson
The RPM Report: Regulation Policy and Market Success, United States
Senior Editor
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