Course Description:
This webinar explores the transformation of in-silico modeling from an experimental tool into a regulatory-accepted element of pharmaceutical Chemistry, Manufacturing, and Controls (CMC). Attendees will learn how these digital approaches accelerate drug development, enhance regulatory confidence, and can greatly shorten time while de-risking the CMC lifecycle.
Introduction to In-Silico Modeling in CMC:
Explanation of core modeling principles (mechanistic, AI-driven, and statistical) and how they interconnect with traditional CMC practices, including formulation, scale-up, and stability.
Benefits and Strategic Impact:
Case studies showing reduced development timelines, lower costs, and improved process optimization and risk management, with real-world regulatory submissions that utilized in-silico data to support shelf-life, process controls, and quality by design frameworks.
Integration and Regulatory Acceptance:
Discussion of recent FDA guidance and international trends demonstrating acceptance of model-informed decision-making for process validation, stability assessment, and clinical trial simulation, highlighting examples where in-silico evidence has de-risked submissions and shortened market entry time.
Transforming CMC Approaches:
How virtual experimentation are CMC workflows, sup porting regulatory dialogue, and improving data packages for IND and BLA/NDA/ANDA filings.
Who should participate:
Pharma and biotech professionals in CMC, R&D, regulatory affairs, and senior leadership—anyone seeking to leverage cutting-edge modeling solutions to drive innovation and regulatory success in drug development.
Though this course is being made available on USP’s
Education site, the course content was developed by Pharmatech Associates, a
USP company. USP has not independently reviewed or verified the accuracy
of the course content.