In Vilnius (Republic of Lithuania), a training course within the Twinning project "Support to the Establishment of a State Control Body for Medicinal Products and Medical Devices" has concluded.
The training was dedicated to the practical aspects of the functioning of the pharmacovigilance system in accordance with European Union legislation and practices.
Together with experts from HALMED (Croatia) and SMCA (Lithuania), pharmacovigilance specialists of the Center worked through key issues of managing medicinal product safety signals — from their detection and validation to confirmation and further assessment, as well as the possibilities of using EudraVigilance data for monitoring the safety of medicinal products.
A separate training block was dedicated to the assessment of risk management plans (RMP), including additional measures for their minimisation and modern digital channels for disseminating information and educational materials.
Considerable attention was paid to practical work: using specific examples, participants practised approaches to signal assessment and RMP, discussed current issues of the Ukrainian pharmacovigilance system, as well as the possibilities of applying European experience in national regulatory practice.
During the training, a joint analysis of certain provisions of the draft regulatory document in the field of pharmacovigilance was also conducted, and approaches to developing standard operating procedures (SOPs) and relevant document templates were considered.
The knowledge and practical experience gained will be used for further improvement of the national pharmacovigilance system, development of the regulatory framework, internal procedures of the Center, and bringing Ukraine's regulatory practices closer to European Union standards.
Participation in Twinning project activities contributes to strengthening the institutional capacity of the Center, developing the professional competencies of experts, and deepening cooperation with the regulatory authorities of EU member states.
