Perspectiva general

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.

Temas destacados

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

¿Quiénes deben asistir?

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

Objetivos de aprendizaje

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

Digital Learning Catalog

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