Specialists of the Center's Pharmacovigilance Department took part in online training by Uppsala Monitoring Centre (UMC).
The aim is to gain practical skills in using the VigiLyse database and to improve skills in assessing the causal relationship of adverse reactions to medicinal products in safety reports.
To gain access to the course, the department’s specialists completed 7 pre-courses and received certificates.
As part of the training, specialists took part in 4 practical sessions and 4 optional sessions (questions and answers), which made it possible to:
- gain skills in identifying potential signals in the VigiLyze database;
- gain practical skills in assessing the causal relationship in reports of individual adverse reaction cases and adverse reaction case series;
- raise awareness of the Austin Bradford Hill criteria when analyzing adverse reactions;
- improve the processes of entering and documenting data in the system, calculate disproportionality coefficients, and apply them to analyze the cause-and-effect relationship;
- determine the assessment category by the WHO-UMC method to establish a causal relationship;
- interpret data from the literature as an important element of causality analysis;
- deepen knowledge of the use of MedDRA in data analysis.
The Center cooperates with, and has been a full member of, the UMC global monitoring system since 2002. As part of this cooperation, it submits to the UMC case reports of adverse events following the use of medicinal products, including cases of AEFI following the use of vaccines.
The Center has full access to the VigiLyze database – the WHO global database for detecting and managing safety signals. Access to VigiLyze and entry of data into it enable prompt exchange of information between member countries on potential risks of medicinal products and vaccines, and minimize the risks of repeated assessment of the same (or similar) medicinal products and their reactions.
