Safety signal management and risk minimization in the use of medicinal products – a pharmacovigilance seminar for applicants was held at the Center
The aim of the training is to deepen knowledge and skills in the analysis and evaluation of medicinal product safety signals, establishing causal relationships, and identifying patterns. To make decisions on confirming or refuting signals. To plan and take risk minimization measures that may affect the safety of a medicinal product.
A course of lectures was delivered by specialists of the Division for Safety Information Monitoring and Management and Assessment of Periodic Safety Update Reports of the Pharmacovigilance Department of the Center: Maryna Lorynets, Anna Maliuhova, Viktoriia Tolokevych, Yuliia Fedorets. The training was organized by the Agency for Methodological and Scientific-Practical Work of the Center.
In their presentations, the speakers covered the concept, principles, and methods of safety signal detection; the signal assessment system; and the Bradford Hill criteria for determining a causal relationship in a series of cases of adverse reactions.
During the practical part, using the example of the “medicinal product – adverse reaction” combination, together with the participants, the causal relationship of each individual case and of a case series was determined, using pattern searching, additional information on pathogenesis, the mechanism of occurrence of adverse reactions, and evidence of class effects. The Bradford Hill criteria were applied to a clear example to confirm a causal relationship in a case series. They learned to assess the problem and make decisions on further actions.
“In the context of ensuring an adequate pharmacovigilance system, with the emergence of the new professional standard ‘Pharmacovigilance Professional’, it is important to deepen applicants' theoretical and practical knowledge of the safety of medicinal products, to receive quality data on adverse reactions in a timely manner, to prevent risks, and to ensure the proper quality and efficacy of medicinal products. From the regulator's point of view, we provide the deepest and highest-quality knowledge in this area,” – emphasized during the seminar the Head of the Agency, Doctor of Pharmaceutical Sciences, Professor, Honored Worker of Health Care of Ukraine Oleksandr Hudzenko.
The seminar received positive feedback from applicants – the practical skills gained will help in the process of managing safety signals and minimizing risks when patients use medicinal products.
As reported earlier, the seminar speakers completed a certified training course from the Uppsala Monitoring Centre on the use of the VigiLyse database – the WHO global database for the detection and management of safety signals http://surl.li/tqwnf
