Safety data related to a medicinal product authorised in the Eureopean Union is generated also in other regions, countries or continents around the globe. The European legislation stipulates that marketing authorization holders are required to maintain a Pharmacovigilance System and make global safety information available. The Pharmacovigilance System Master File (PSMF) is expected to present information on the pharmacovigilance system applied at global, regional and local levels.
During the course we will explore the current global regulatory framework and different options for the design and management of a global Pharmacovigilance System Master File.
Participants are expected to have a firm understanding of the GVP Module II - Pharmacovigilance system master file.