The “Context of Use” (COU), as defined by the European Medicines Agency (EMA), is a comprehensive and well-defined description of how a novel methodology is intended to be applied and the specific purpose within the context of medicine development. This document serves as a crucial reference point for the regulatory evaluation of any qualification application.
The COU outlines the precise circumstances, objectives, and scope of applying a new methodology in the development of medicines. It provides clear guidance on how this methodology will be employed and what role it plays in various aspects of drug development and assessment. The COU document is a cornerstone in the regulatory process, helping regulatory authorities and stakeholders assess the appropriateness and potential benefits of the proposed methodology within the broader framework of pharmaceutical development.
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