Global Pharmacovigilance System Master File

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.

• PV system
• Regulatory requirements for PV system description
• Relation between EU and non-EU PSMF
• Global & Regional & Local PSMF and related procedures
• Sharing EU PSMF outside EU vs GDPR

This course is designed for professionals involved in:

• Design and management of global PV system
• Preparation and maintenance of PSMF
• Global and local PV functions
• QPPVs
• Regulatory affairs
• Quality assurance
• or similar positions within the industry

At the conclusion of this virtual live training course, participants will be able to:

• Describe the global regulatory framework for description of Pharmacovigilance systems
• List the key components of Pharmacovigilance descriptions in selected countries/regions and identify potential differences
• Differentiate and assess different structures for a global PSMF