CRED Managing Variations Effectively

B. Quality Changes

III. CEPs / TSE monographs 1. New/updated CEPs & TSE CEPs, 2. Changes to comply with Ph. Eur. or Ph. From a Member State

IV. Medical devices – Changes to integrated / non-integrated medical device

V. Changes to the dossier due to other regulatory procedures – 2 nd step of PMF / VAMF, – Update of Module 3 following a referral

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