FDA/Center for Research on Complex Generics (CRCG) Workshop on Modeling and Artificial Intelligence (AI) in Generic Drug Development and Product Lifecycle Management: Regulatory Insights and Future Trends October 15 - 16, 2025

Workshop | Mixed

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• Date: October 15 - 16, 2025
• Day1: Wed, Oct 15 8:30 a.m. - 05:00 p.m. ET
• Day2: Thu, Oct 16 8:30 a.m. - 03:40 p.m. ET
• Location: The Universities at Shady Grove; Building II; 9630 Gudelsky Drive; Rockville, MD 20850; United States

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This 2-day hybrid (virtual and in-person) workshop 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.

For more information, please visit the Center for Research on Complex Generics website for this Workshop.