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Pathways to Innovation: Navigating Regulatory Expectations for AI Technologies in Drug Development
Session Chair(s)
Ryan Hoshi, PhD, MBA, MSc
Director, Regulatory Policy and Intelligence
AbbVie, United States
This session will explore engagement pathways with global regulators to obtain feedback on AI technologies in drug development. It will also identify effective evaluation strategies to support regulatory acceptance of novel methodologies.
Learning Objective : Identify the appropriate regulatory pathways and mechanisms for engaging with health authorities to discuss AI technologies in drug development applications; Discuss regulatory strategies, use cases, and considerations for AI model development based on context of use; Evaluate lessons learned and experiences from manufacturers, developers and health authorities.
Speaker(s)
AI and Machine Learning in Pharmaceutical Manufacturing
Gert Thurau, DrSc, PhD
F. Hoffmann-La Roche Ltd, Switzerland
Head of Manufacturing Technology Innovation in CMC Regulatory Policy
EMA Perspectives on the Use of AI in the Lifecycle of Medicines
Representative Invited
European Medicines Agency, Netherlands
FDA Perspectives on the Use of AI to Support Regulatory Decision-Making for Drug and Biological Products
Representative Invited
FDA, United States
Technical and Regulatory Considerations for Streamlining Drug Development with Digital Twins: Sample-size Reduction Case Study
Aaron Smith
Unlearn.AI, United States
Founder, Machine Learning Scientist
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