FDA-CRCG Workshop on Modeling and AI in Generic Drug Development and Product Lifecycle Management

October 15-16, 2025

About

This workshop, held October 15-16, 2025, focuses on exploring the opportunities, applications, and regulatory considerations of Artificial Intelligence (AI) in generic drug development and product lifecycle management. The workshop will include comprehensive sessions examining regulatory perspectives from global agencies, practical applications of AI in streamlining workflows, and innovative AI and modeling approaches to facilitate drug development and quantitative medicine. The program features expert presentations from regulatory scientists, industry leaders, and academic researchers, complemented by interactive Q&A panels and small group discussions for in-person attendees. This collaborative forum aims to advance an understanding of AI’s potential to enhance efficiency, accuracy, and regulatory compliance throughout the generic drug development continuum, while addressing the evolving regulatory landscape that shapes the safe and effective integration of AI technologies in pharmaceutical innovation.

Topics

• Regulatory Perspectives: Current thinking from FDA, EMA, and other global regulatory bodies on AI integration in drug development and assessment processes
• AI-Driven Workflow Optimization: How AI enhances efficiency in regulatory writing, product development, and modeling workflows
• AI in Drug Development: Exploration of AI’s role in transforming drug development processes, including predictive modeling for drug substance development, formulation optimization, and process optimization
• AI and Quantitative Medicine: Discussion on how AI/ML approaches are extending quantitative medicine approaches, from pharmacometrics and systems pharmacology to translational modeling and digital twins