CRED Managing Variations Effectively

Editorial changes in variations: What and how can I submit? (II) Editorial changes should always be clearly identified in the application form: – provide a brief description in the Precise Scope . – list all editorial changes in the present/proposed table , – for each change, add a justification why is considered ‘editorial’ – provide a declaration in the ‘Precise scope and background…’ section confirming that the editorial changes: • (Module 3) do not change the content of the concerned part(s) beyond the scope of the variation, or • (PI) do not change the content or previously approved PI.

Introduction to Classification of CMC (Quality) / Clinical / PhV Variations

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