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International Clinical Trials

Post-Marketing Pharmacovigilance

European legislation requires that marketing authorisation holders (MAHs) should have an appropriate system for pharmacovigilance (PV) in place. Since the introduction of the updated legislation in July 2012, a set of guidelines for the conduct of PV has been developed by the EMA, known as good pharmacovigilance practice (GVP) modules, to support its implementation (1-4). Each GVP module covers one major PV process. The obligations are the same regardless of the MAH size or if the MAH is an innovative or a generic pharmaceutical company. However, the legislation and regulations do not stipulate how the MAH fulfils these obligations. It is up to the individual MAH to interpret the legislation and regulations and present, at audits and inspections, a system that complies with the requirements.

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About the authors

Emma Boulton is the Head of Pharmacovigilance for UK and Ireland at Napp Pharmaceuticals. She has over 20 years of PV experience in both preand post-marketing. Emma is a serving committee member of PIPA and the Co-Chair of the PIPA training working party. Emma is a qualified nurse and holds a post-graduate diploma in Pharmacovigilance.

Dora Amene is the Pharmacovigilance Manager at TMC Pharma Services. She is a serving committee member of PIPA and Co-Editor for PIPA’s journal, which is published at least three times a year. Dora has a Master’s degree in Pharmacovigilance and seven years of PV experience in post-marketing and, recently, in clinical.

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