It is essential that those who hold Marketing Authorisations (MA) within the European economic area have an established Pharmacovigilance System Master File (PSMF), which should be ready at the time of submission of all new applications for MAs.

In this whitepaper ICON’s experts provide an overview of the Pharmacovigilance System Master File (PSMF) and discuss how it has evolved over the last ten years, both inside and outside of the European Union. Authors will also provide an assessment of:

• Benefits of creating a “Core PSMF”
• Methods of maintaining an effective global PSMF
• Operational and technological considerations
• Best practices to ensure global pharmacovigilance (PV) efficiency and compliance