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
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use topic E 2 E: Pharmacovigilance planning - Step 5 (PDF/225.43 KB)Adopted
First published: 31/12/2004
Last updated: 31/12/2004
Legal effective date: 01/06/2005