A workshop for applicants on the risk management of medicinal products was held at the State Expert Center of the Ministry of Health of Ukraine. 26 participants took part in the training – pharmacovigilance specialists, representatives of regulatory units, registration departments, and departments for the development of medicinal product safety documentation.
The seminar was opened by the Head of the Agency for Methodological and Scientific-Practical Work, Professor, Doctor of Pharmaceutical Sciences Oleksandr Hudzenko, who emphasized the importance of a systematic approach to risk management throughout the entire life cycle of a medicinal product. He separately emphasized the role of the Center as a provider of professional development in deepening the professional skills of medical and pharmaceutical personnel in Ukraine.
The program covered a range of key issues:
- principles of medicinal product risk management, routine and additional risk minimization measures;
- safety communication, specifics of preparing and coordinating materials by applicants;
- approval of communication materials by the Center, typical mistakes in preparing documents and practical examples;
- assessment of the effectiveness of risk minimization measures – conceptual approaches, criteria for success and failure, assessment methods, interpretation of results, and possible regulatory consequences.
The practical session was aimed at systematizing knowledge and practicing skills – in a testing format, participants practiced selecting the most effective routine and additional risk minimization measures for medicinal products in various therapeutic models of clinical situations.
The speakers were experts of the Center with more than five years of experience in pharmacovigilance: Yevheniia Skoryk, Yuliia Fedorets, Iryna Rieztsova, Kateryna Tsariova.
Participants considered how to properly develop and implement risk minimization measures within Risk Management Plans (RMPs). Attention was focused on the importance of the RMP summary as a tool for transparency and for informing the public about the safety profile of medicinal products. In 2025, the Center has already published more than 560 RMP summaries on the official website https://www.dec.gov.ua/patient/2025-rezyume-pur/?role=patient
Special attention is paid to safety communications – the preparation of direct healthcare professional communications (DHPC) and educational materials for healthcare professionals and patients, which are part of additional risk minimization measures https://www.dec.gov.ua/doctors/2025-listi-zvernennya-do-medichnih-ta-farmaczevtichnih-praczivnikiv/?role=doctors
The knowledge gained is extremely important for applicants, as it ensures an understanding of the regulatory requirements for the risk management system and helps improve the quality of preparation of medicinal product safety documents.
For pharmacovigilance professionals, this is another opportunity to strengthen the safety culture and prevent risks at all stages of the life cycle of a medicinal product.
