CRED Managing Variations Effectively

1. Introduction to classification of variations

Simply put, a variation is any change to the dossier supporting the marketing authorisation The need for classification of such changes stems from the fact that not all changes have the same level of complexity nor require the same level of assessment (scrutiny) before approval. Additionally, different variation types requires different expertise (Quality, Non-Clinical, Clinical, Pharmacovigilance) for their assessment. Finally, classification allows reporting on volumes of variations (e.g. to ascertain the impact of legislation changes).

Introduction to Classification of CMC (Quality) / Clinical / PhV Variations 35