On 28 February, the Center held a workshop for applicants on pharmacovigilance “Risk minimization measures for medicinal products. Evaluation of effectiveness”. The purpose of the training is to provide practical recommendations on selecting risk minimization measures for medicinal products both at the registration stage and in the post-registration period, as well as on implementing and evaluating the effectiveness of these measures.
The seminar was organized by the Agency for Methodological and Scientific-Practical Work jointly with the Pharmacovigilance Department of the Center. The course was taught by experts in pharmacovigilance and expert evaluation of medicinal product safety materials of the Center, Yevheniia SKORYK and Yuliia FEDORETS.
Yuliia FEDORETS, an expert of the Department of Safety Information Monitoring and Management and PSUR Assessment, presented information on the risks that occur when medicinal products are used and drew attention to the routine and additional safety measures that must be taken to minimize risks. She spoke in detail about preparing the risk minimization measures program and safety communication materials, which are an integral part of the risk management plan (RMP). Using examples, she helped the audience understand the typical mistakes made when drawing up an RMP and when developing and approving information materials that constitute additional risk minimization measures.
Yevheniia SKORYK, Head of the Department for Expert Evaluation of Medicinal Product Safety Materials, devoted her presentation to evaluating the effectiveness of risk minimization measures – the concept, tasks and approaches. She introduced the latest international updates in this area, Module XVI GVP EMA (2024). Together with the participants, she examined the process of disseminating risk minimization measures to the target audience, the criteria of success and failure during the evaluation, the interpretation of results and regulatory consequences. She stressed the importance of regularly updating the RMP and verifying the relevance and effectiveness of risk minimization measures.
During the practical part, the participants jointly analyzed several case studies to consolidate the material and discussed the most common mistakes from practice with the experts.
The event was useful for the professional development and skill improvement of registration and pharmacovigilance specialists. We congratulate the participants on gaining valuable knowledge and certificates!
