FDA Modeling and AI in Generic Drugs 2025: Regulatory Perspectives and Opportunities – Presentations скачать в хорошем качестве

FDA Modeling and AI in Generic Drugs 2025: Regulatory Perspectives and Opportunities – Presentations

SUBSCRIBE to ⁨@FDALearningCache⁩ to see more videos. Details and supporting materials: https://fdalearn.com/course/fda-crcg-... 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