Good Pharmacovigilance Practice Guide

This essential reference guide relates to pharmacovigilance of medicinal products for human use. It complements currently available EU legislation and guidance and provides practical advice to key stakeholders, in particular Marketing Authorisation Holders, about achieving an appropriate system of pharmacovigilance. Contents include: roles and responsibilities of the EEA Qualified Person for Pharmacovigilance; managing case reports and other safety information; ongoing evaluation of safety data; quality management aspects of pharmacovigilance; managing contracts and agreements; pharmacovigilance beyond the drug safety department. The Good Pharmacovigilance Practice Guide is the result of collaboration between different groups within the MHRA, including the GPvP Inspectorate, the Pharmacovigilance Group and the Clinical Trials Unit. By highlighting the areas in which inspection findings are commonly found and providing specific examples of good or poor practice, the guide can assist organisations in developing effective pharmacovigilance systems.