This Practice Note deals with pharmacovigilance. It sets out the EU and UK regulatory framework and discusses the role of the Pharmacovigilance Risk Assessment Committee (PRAC), EudraVigilance and the guidelines on good pharmacovigilance practices (GVPs). It then takes a more detailed look at the pharmacovigilance processes and requirements set out in the GVP modules, including: how to establish a pharmacovigilance system, the qualified person responsible for pharmacovigilance (QPPV), the pharmacovigilance system master file (PSMF), pharmacovigilance inspections, pharmacovigilance audits, periodic safety update reports (PSURs), and post-authorisation safety studies (PASS). The Practice Note then considers non-compliance with pharmacovigilance requirements, data protection considerations, and outsourcing pharmacovigilance activities. Finally, it discusses pharmacovigilance in the UK and the role of the Medicines and Healthcare products Regulatory Agency (MHRA).
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