FDA Modeling and AI in Generic Drug Development 2025: AI Supporting Drug Development - Presentations скачать в хорошем качестве

FDA Modeling and AI in Generic Drug Development 2025: AI Supporting Drug Development - Presentations

SUBSCRIBE to ⁨@FDALearningCache⁩ to see more videos. Details and supporting materials: https://fdalearn.com/course/fda-crcg-... About: AI is becoming increasingly integral to the future of generic drug development. This session will explore how AI offers innovative solutions in transforming the generic drug development process by enhancing efficiency, accuracy, speed, cost, regulatory compliance, and to improve the quality of generic medicines. The session will delve into practical applications of AI within the generic drug domain, including predictive modeling for drug substance development, formulation optimization, intelligent data analysis for bioequivalence assessment, streamlining regulatory pathways, process optimization and scale-up, and post-market surveillance. Presentations: Speaker Introductions Jayanti Das, PhD Research Scientist, DPQR VI, OPQR, OPQ, FDA Use Cases of GenAI Implementation in Generic Pharmaceutical Company Volodymyr Stus, MD Head of the Clinical Department, R&D PharOs Ltd Maturity Framework to Accelerate AI Impact in CMC: Use Cases for Drug Substance and Drug Product Ian Houson, DPhil Programme Manager, Digital CMC CERSI, CMAC, University of Strathclyde Considerations of Pharmaceutical Manufacturing Process Models for Drug Product Development Katie Duncan, PhD Director, CMC Policy and Advocacy, GlaxoSmithKline Digital Regulatory Transformation: Where Innovation Meets Harmonization J. Paul Kirwan, PhD Senior Manager, Regulatory Affairs CMC. Amgen