Back to: FDA-CRCG Workshop on Modeling and AI in Generic Drug Development and Product Lifecycle Management
About
AI introduces new ways to enhance how we access, interpret, and apply knowledge. These technologies complement experts, helping them work more efficiently, consistently, and insightfully. This session will focus on the use of AI for streamlining workflows, which include, but are not limited to, regulatory writing or assessment, product development, and model development. We will delve into discussions on current practices in this area with real-world examples in which AI is being used to advance workflows relevant to promoting and accelerating generic drug development.
Presentations
Speaker Introductions
Meng Hu, PhD
Team Lead, DQMM, ORS, OGD, FDA
Harnessing AI for Transforming Generic Pharmaceutical Value Chain: A Regulatory-Focused Peptide Product
Development Case Study
Senthil Kumar S., MTech
Principal Product Manager, R&D, Digital & Process Excellence, Dr. Reddy’s Lab
Generic Drug Structured Assessment-Bioequivalence and Advent of Artificial Intelligence Integration
Rajan Jog, PhD
Senior Scientific Reviewer, DB I, OB, OGD, FDA
Leveraging Generative AI to Support Regulatory Assessments
Meng Hu, PhD
Team Lead, DQMM, ORS, OGD, FDA
Quantitative Systems Pharmacology at Scale with Generative AI
Joshua Apgar, PhD
Vice President QSP Software, Certara
Accelerate. De-Risk. Succeed in the Age of AI
Pravin Jadhav, PhD, MPH
CEO, Vivpro Corp
From Idea to Impact: Streamlining AI Integration Across the Enterprise
Devin Pastoor, PhD
Chief Technology and Product Officer, A2-Ai