On 27–28 November 2025, the European Medicines Agency (EMA) organized a hybrid training in Amsterdam, Kingdom of the Netherlands, titled “2025 EU Pharmacovigilance Inspectors Working Group Training course”.
From the Analytical Expertise Center of the Ministry of Health, the training was attended by: Farid Hasanov, Head of the Pharmacovigilance department — in person; Khalisa Akberova, Deputy head of the department, and Rafiqe Ibrahimova, department expert — online.
The training was designed for pharmacovigilance inspectors from national regulatory authorities and pharmacovigilance centers. A total of 89 representatives from Azerbaijan, Turkey, the United Kingdom, Brazil, Thailand, and the 27 member countries of the European Union participated in the training in person, and more than 150 representatives participated online.
During the two-day training, the following topics were presented: “Signal management” – (Common principles); “Big vs. small companies” – (Special features of small companies and their inspection, Special features of big companies and their inspection); “Guideline on good pharmacovigilance practices (GVP) Module XVI – Risk minimisation measures – implementation of Rev 3” – (Overview on the GVP Module XVI rev.3, What is reviewed by Assessors on the implementation of RMMs at EU/PRAC level, What is reviewed by Assessors on the implementation of RMMs at national level, What is seen at the inspections).
In addition, the event included: “Big vs. small companies – Workshop” – (Discussion on case studies, Consolidation of the discussions); “Pharmacovigilance System Master File (PSMF) findings and harmonization of expectations”; Extended EudraVigilance medicinal product dictionary (XEVMPD) training for inspectors — Introduction & Workshop on examples.
The sessions involved discussions on case studies from large and small companies, alignment of findings with PSMF expectations, and practical exercises with the XEVMPD dictionary for pharmacovigilance inspectors.
