Back to: FDA-CRCG Workshop on Modeling and AI in Generic Drug Development and Product Lifecycle Management
About
This session underscores the critical importance of understanding global regulatory frameworks to responsibly harness AI in the lifecycle of drug development. By exploring the evolving standards, policies, and opportunities for AI integration, this session will highlight how regulatory landscape shapes the safe, effective, and innovative application of AI in advancing pharmaceutical innovation throughout the drug development lifecycle.
Presentations
Speaker Introductions
Lanyan (Lucy) Fang, PhD
Deputy Director, DQMM, ORS, OGD, FDA
FDA Guidance on the Use of AI in Drug Development and Regulatory Assessment
Gabriel Innes, VMD, PhD
Assistant Director, Data Science and AI Policy, OMP, FDA
EMA AI Reflection Paper
Luis Pinheiro, PharmD, MEpi
Senior Epidemiology Expert, European Medicines Agency
AI Use in Generic Drugs
Robert Lionberger, PhD
Director,ORS, OGD, FDA