ICH E2E Pharmacovigilance planning (Pvp) - Scientific guideline

Table of contents

This 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.

Keywords: Pharmacovigilance activities, safety specification, pharmacovigilance plan, safety database, risk, interactions, epidemiology, class effect, observational studies


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