ICH E2E Pharmacovigilance planning (Pvp)

Current effective version

PDF iconAdopted guideline

Reference numberCPMP/ICH/5716/03
Effective from01/06/2010
KeywordsPharmacovigilance activities, safety specification, pharmacovigilance plan, safety database, risk, interactions, epidemiology, class effect, observational studies
DescriptionThis document provides guidance on planning pharmacovigilance activities, especially in preparation for the early postmarketing period of a new medicinal product. It applies to chemical entities, biotechnology-derived products and vaccines.


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