Overview
Safety data related to a medicinal product authorised in the European Union are generated also in other regions, countries and continents around the globe. The European legislation stipulates that marketing authorisation 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 for the description of pharmacovigilance systems and different options for the design, implementation and management of a global Pharmacovigilance System Master File.
The course includes practical exercises on governance model selection, PSMF contributors and sources, update timelines, and a scalable PSMF tracker.
Participants are expected to have a firm understanding of GVP Module II – Pharmacovigilance system master file.
Participant Testimonials
This was a very interesting, easy to follow training course. It has completed my knowledge on EU PSMF and provided new useful information on global PSMF requirements. Besides the theoretical benefit, the practical solutions presented by Marcela are easy to implement and adapt to every company's internal setting. Sharing our experience and brainstorming in a forum of SMEs was very productive, as we all face the same challenges. Thank you, DIA and the trainers for a great and productive training experience! – Maria-Lucica Amza – Drug Safety Specialist
DIA Global PSMF training course
Have an account?