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.

Subject area:
cGMP

Objectives (If applicable):
N/A

Target Audience (If applicable):
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.