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Opportunity, Caution or Reluctance: Global Trends for Regulating AI in Pharmaceutical Manufacturing
Session Chair(s)
Gert Thurau, PHD
Head of CMC Regulatory Policy for Manufacturing Technology Innovation in
F. Hoffmann-La Roche Ltd, Switzerland
Artificial intelligence is revolutionizing drug manufacturing, yet regulations are still catching up. With key guidance from the EU and US in development, a proactive and collaborative approach is needed for global regulatory alignment, ensuring AI i
Learning Objective : Identify and summarize regulatory trends specific to AI use in Manufacturing; Distinguish AI use in manufacturing from use in product development.
Speaker(s)
FDA regulatory perspectives on AI in Manufacturing
Representative Invited
FDA, United States
PMDA regulatory perspectives on AI in Manufacturing
Yoshihiro Matsuda, DrMed
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Senior Scientist (for Quality), Pharmacist
Case Study Industry applications of AI
Thomas O'Connor, PHD
GSK, United States
Director Process Analytics
Health Canada regulatory perspectives on AI in Manufacturing
Representative Invited
Health Canada, Canada
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