The first training sessions and exchange of experience on EU and Ukrainian pharmacovigilance processes have been completed at the State Expert Center of the Ministry of Health of Ukraine. The events took place from 23 to 27 March 2026 as part of the implementation of the Twinning project and became an important step in strengthening the national system for monitoring the safety of medicinal products in accordance with EU standards.
The training sessions were conducted by international experts of the Twinning project: Lina Seibokene, the project's permanent adviser, an EMA-accredited expert at the Lithuanian State Medicines Control Agency, and Petr Mas, the project expert, a clinical pharmacology specialist at the Agency for Medicinal Products and Medical Devices of Croatia. Other experts from Lithuania joined online.
The events were attended by the Director of the Pharmacovigilance Department Tetiana Bashkatova, the Head of the Medicinal Product Safety Materials Division Yevheniia Skoryk, and pharmacovigilance experts of the Center.
During the week, the participants worked through key aspects of pharmacovigilance, in particular the management of adverse reactions at the national and European levels, the detection and management of safety signals, the preparation of periodic safety update reports (PSURs) and risk management plans, the application of risk minimisation measures and interaction between agencies.
Special attention was paid to safety assessment during clinical trials (AE, ASR/DSUR) and to discussion of issues – the Center's experts received answers to practical questions that arise in their daily work.
The training continued during air raids as well: work was continued in the shelter. Because even in such conditions we do not stop and continue to build the system. European partners noted that the vast majority of processes in the field of pharmacovigilance in Ukraine already comply with the requirements of the European Union.
Within the framework of the project, the participation of the Center's experts in training in other areas of regulatory activity is planned, which will contribute to the comprehensive strengthening of the institutional capacity of the system.
For reference. The Twinning project, which started in Ukraine in October 2025, is a European Union instrument for institutional cooperation, the introduction of European practices and support for reforms. It is being implemented with the support of the European Commission in partnership with Lithuania, Poland and Germany and will last 18 months.
The aim of the project is to create in Ukraine a modern regulatory authority that will meet EU standards in the field of registration, quality control and safety of medicinal products. The work focuses on three strategic areas: harmonisation of legislation with EU norms, development of organisational capacity and building of expert potential.
