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Bridging the AI Divide: Regulatory Trends, Industry Innovation, and the Future of AI in Pharma & Biotech
Session Chair(s)
Antonella Lozito, PHARMD
Vice President, Global Regulatory Affairs
Moderna, United States
Artificial Intelligence is redefining pharma and biotech. This session contrasts AI-native and traditional models, examines FDA, EMA, and EU AI frameworks, and delivers strategies to ensure credible, compliant AI use in regulatory decision-making.
Learning Objective : Differentiate between AI-native and traditional pharma/biotech models in drug development; Assess regulatory expectations for AI from FDA, EMA, and the EU AI Act; Apply strategies to establish AI model credibility for regulatory decision-making.
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