Pharmacovigilance Officer (RPV): Definition, Role and Outsourcing
Pharmacovigilance Officer (RPV): Definition, Role and Outsourcing Sommaire The Pharmacovigilance Officer ensures that all regulatory pharmacovigilance (PV) obligations are complied with by the marketing authorization holder or operator of a medicinal product. This person is also referred to as the “pharmacovigilance contact person.” In France, health safety relies on a stringent regulatory framework, and the […]
EMA GVPs: A Structuring Framework, Often Underestimated, for Marketing Authorisation Holders’ Pharmacovigilance Systems
EMA GVPs: A Structuring Framework, Often Underestimated, for Marketing Authorisation Holders’ Pharmacovigilance Systems Sommaire European pharmacovigilance is built upon a well-established foundation: the Good Pharmacovigilance Practices (GVPs) published by the EMA. Known to all stakeholders working in pharmacovigilance, they are nevertheless sometimes approached as a body of documentation to be mastered, rather than as a […]