Introduzione
Understanding of the regulatory framework for veterinary pharmacovigilance is one of the essential requirements for professionals aiming to begin their journey in this discipline. All personnel involved directly or indirectly in pharmacovigilance activities at various levels in an organisation must be trained and competent for the undertaking of assigned roles.
The goal of this introductory course is to provide an overview of the new veterinary regulation and its requirements, which includes the receipt and reporting of adverse event, pharmacovigilance system master file (PSMF), regulatory inspection, inclusion of new procedures in the quality management system, introduction of portals for the uploading of data including Union Product Database (UPD), EVVET, Union Pharmacovigilance Database and IRIS. There will be workshops and discussions for practical understanding of the concepts and regulatory requirements.