EU Guidelines on Good Pharmacovigilance Practices (GVP Module IV), mandate that all Marketing Authorisation Holders (MAHs) perform audits of their Pharmacovigilance Systems.
PVpharm provides a risk-based Pharmacovigilance Audit Service, which focuses on the areas of highest risk to an organisation’s pharmacovigilance system, taking into account applicable local regulatory requirements.
Our approach is risk and process based, our objective is to improve your pharmacovigilance system in order to achieve excellence in quality. We can perform face-to-face or remote audits.
Our audit team consist of a group of experts in pharmacovigilance with several years of experience.
Please contact us for more information.