Back to Agenda
Innovations in Drug Review
Session Chair(s)
Andrew Emmett, MPH
VP, 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 : Anticipate and strategize new drug review practices, and highlight key PDUFA 8 enhancements; Understand the evolving role of technology (AI, cloud) in drug evaluation; Compare-and-contrast drug review practices globally.
Have an account?