Future-Proofing Your CMC Strategy: Managing Critical Starting Material Changes
Changing a critical starting material, whether driven by supply chain risk, a new supplier, process improvement or obsolescence, can have significant implications for analytical comparability, stability, regulatory strategy and development timelines.
In this on-demand webinar, Sandeep Yadav, PhD, Principal at SY Biopharma Consulting, explores the key considerations involved in preparing a regulatory submission to support a critical starting material change. Drawing on real-world experience, he discusses how to build a scientifically sound, risk-based justification that addresses regulatory expectations while keeping development programmes on track.
What you’ll learn in this webinar
How to define and justify a critical starting material, and how its classification can shape CMC strategy and regulatory pathways
What regulators expect from comparability data, risk assessments and the scientific evidence supporting a critical starting material change
How to structure an effective CMC submission and communicate proactively with regulatory agencies
Key considerations when navigating differing expectations across agencies, including the FDA and EMA
How to plan for implementation and manage timelines when starting material changes are unavoidable or urgent
Navigating critical starting material changes with a risk-based CMC strategy
Changes to critical starting materials can affect multiple aspects of a development programme, from manufacturing and analytical comparability to stability and regulatory submissions. A well-planned CMC strategy can help teams assess the potential impact of a change, generate appropriate supporting evidence and establish a clear scientific rationale.
This webinar provides practical considerations for approaching these changes throughout development and preparing the evidence needed to support regulatory interactions and submissions.
Who should watch
CMC and Regulatory Affairs professionals
Process Development and Manufacturing scientists
Analytical Development and Quality professionals
Technical and Project leaders responsible for CMC strategy, process changes and lifecycle management