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Innovations in Drug Review: A Global Perspective
Session Chair(s)
Andrew Emmett, MPH
Vice President, Global Regulatory Policy and Global Intelligence
Pfizer, United States
This roundtable will discuss innovations in drug review, including real-time review, AI-enabled dossier analysis, cloud data exchange, mid-cycle communications, and cross-disciplinary review, and how modern tools create a dynamic review environment.
Learning Objective : Examine drug review practices, and highlight key PDUFA VIII enhancements; Describe the evolving role of technology (AI, cloud) in drug evaluation; Explain drug review practices globally.
Speaker(s)
Innovations in Drug Review: An EMAPerspective
Representative Invited
European Medicines Agency, Netherlands
Innovations in Drug Review: An Industry Perspective
Mark Taisey
Amgen, United States
Senior Vice President, Global Regulatory Affairs & Strategy
Panelist
Representative Invited
FDA, United States
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