A group of specialists from the State Expert Center of the Ministry of Health of Ukraine, led by Deputy Director for Registration, Pharmacovigilance and Audit Olena Semenchenko, successfully completed participation in the first of three modules of the international educational programme on medicinal product regulation "Life Cycle of Pharmaceuticals", which was held at Uppsala University (Sweden) from 08 to 12 June.
The training took place at the invitation of the Swedish Medical Products Agency (Läkemedelsverket) and the Uppsala Monitoring Centre (Uppsala Monitoring Centre, UMC). The Ukrainian delegation also included representatives of the State Service of Ukraine on Medicines and Drugs Control and the Youth Council under the Ministry of Health of Ukraine.
During the week, our experts became acquainted with modern European approaches to the regulation of medicinal products at all stages of their life cycle – from preclinical/clinical studies and medicinal product development to its registration, post-registration surveillance and risk management.
Particular attention was paid to the practical aspects of the functioning of the European regulatory system, in particular:
- building the evidence base for regulatory decision-making;
- assessment of the results of preclinical and clinical studies;
- regulation of advanced therapy medicinal products (ATMP);
- quality control of medicinal products at the development and manufacturing stage;
- application of evidence-based medicine, health technology assessment and biostatistics;
- modern pharmacovigilance tools, including the work of the global VigiBase database and safety signal detection systems;
- approaches to risk management, the role of national and international regulatory authorities in ensuring the safety of medicinal products.
Participants had the opportunity to learn not only about theoretical approaches but also about practical cases of regulatory decisions and the specifics of interaction between regulatory authorities and the healthcare system.
The experience gained is valuable for Ukraine in the context of European integration and the development of a modern system of medicinal product regulation. The acquired knowledge and practices will contribute to enhancing the professional competence of the Center's experts, the implementation of European regulatory approaches, and the building of institutional capacity of the future state control body.
Participation in the programme became an important step for deepening international cooperation and professional dialogue with leading European institutions.
The State Expert Center of the Ministry of Health of Ukraine expresses its sincere gratitude for the organization of the training to the Ministry of Health of Ukraine, the Swedish Medical Products Agency (Läkemedelsverket), Uppsala University and the Uppsala Monitoring Centre (UMC) for the invitation, support and the opportunity to join this important educational initiative.
