PhV
The legislation on pharmacovigilance from July 2012 established legal requirements for the Marketing Authorisation Holder (MAH) to perform regular risk-based audits of its pharmacovigilance (PhV) system. The guidance on planning and conducting the legally required audits are included in the Guideline on Good Pharmacovigilance Practices (GVP Module IV) of the European Medicines Agency (EMA). Having adequately qualified and experienced auditors SciencePharma provides risk-based audit services to provide independent, objective opinion on the MAH pharmacovigilance system.