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Good Pharmacovigilance Practice Guide (MHRA Purple Guide) 2009/2010

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Good Pharmacovigilance Practice Guide

(MHRA Purple 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 Authorisdation Holders, about achieving an appropriate system of pharmacovigilance.
This 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 god or poor practice, the guide can assist organisation in developing effective pharmacovigilance systems.
ISBN 978 0 85369 834 0 2009 / 2010

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