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