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

Topics

How useful was this page?

Add your rating
Average
3 ratings
2 ratings
2 ratings
4 ratings