As part of cooperation with the Uppsala Monitoring Centre (UMC), the Center's specialists completed an in-person training course on signal detection and causality assessment of adverse reactions to medicinal products and received certificates.
The Director of the Pharmacovigilance Department of the Center, Tetiana Bashkatova, and the Head of the Division for Monitoring and Management of Safety Information and Assessment of Periodic Safety Update Reports, Maryna Lorynets, took part in the training at the UMC office (Uppsala, Kingdom of Sweden). The course became the official completion of the training program that began back in 2023. Then, during June–September 2023, specialists of the Center successfully completed a cycle of UMC online training on safety signal detection and case series assessment using the Bradford Hill criteria.
As part of the course led by UMC instructors, participants practiced the practical skills of assessing a case series using the Bradford Hill criteria and presented the results obtained. Ukraine became one of 20 participating countries that were able to deepen their knowledge and skills in pharmacovigilance at the international WHO Center for Monitoring the Safety and Efficacy of Medicinal Products.
The training helped our specialists to:
- to thoroughly work through each stage of the signal management procedure (searching for the index case, calculating disproportionality, identifying risk factors and other causes of the development of an adverse reaction to the medicinal product, assessing the causal relationship between the use of the medicinal product and the occurrence of adverse events, searching for scientific literature confirming the “adverse reaction – medicinal product” link, assessing a case series using the Bradford Hill criteria);
- practice skills in more advanced use of VigiLyse;
- familiarize themselves with the operation of the new information product developed by UMC specialists, VigiVec and VigiGroup;
- to exchange experience with instructors of the Uppsala Monitoring Center and pharmacovigilance representatives of regulatory authorities of other countries;
- strengthen ties with representatives of the international community.
The knowledge and experience gained, according to Tetiana Bashkatova, will help improve the Center’s work in managing medicinal product safety signals and increase the level of practical skills. This will make it possible to substantially deepen the quality of national medicinal product safety reporting, cooperation with applicants and the medical community, and the exchange of medicinal product safety information at the international level.
