The Center held a seminar on the safety of medicinal products, the second in a series of pharmacovigilance topics under the State Expert Center's Training Events Program. The event was organized by the Center's Agency for Methodological and Scientific-Practical Work.
About 20 participants took part – specialists and managers of leading pharmaceutical companies engaged in pharmacovigilance.
The seminar was devoted to special issues of managing medicinal product safety information, namely:
- the basic requirements for the applicant's monitoring of medicinal product safety information;
- monitoring and management of safety information posted on the websites of stringent regulatory authorities;
- the safety communication process within the regulatory system of Ukraine.
Presentations and reports on the indicated issues were delivered by specialists of the Division for Safety Information Monitoring and Management and Evaluation of Periodic Safety Update Reports of the SEC Pharmacovigilance Department – Head of the Division Maryna Lorynets and Division expert Viktoriia Tolokevych.
As is known, the Center is the authorized body responsible for supervising the safety of medicinal products authorized for medical use in Ukraine, and provides recommendations on measures for their safe and effective use by coordinating the processes of evaluation, development, and implementation of pharmacovigilance legislation requirements and their monitoring.
During the seminar, together with the speakers, the participants discussed the most relevant theoretical and practical aspects of pharmacovigilance in line with current scientific knowledge: management, monitoring, reporting, and communication. They received answers to questions, the necessary guidelines, and useful recommendations from the Center's specialists.
While presenting the certificates, Head of the Agency for Methodological and Scientific-Practical Work of the Center Oleksandr Hudzenko emphasized the importance of continuous professional development of medical and pharmaceutical personnel, noted the Center's role as a CPD provider in this area, and urged those present to also join the Center's upcoming seminars and trainings.
З отриманням сертифікатів учасників семінару привітала також і директор Департаменту фармаконагляду ДЕЦ Тетяна Башкатова. Вона відзначила готовність до тісної співпраці із заявниками у напрямку фармаконагляду та надання з боку Центру усієї необхідної для ефективної взаємодії інформації. Закликала заповнити отримані під час навчання анкети-відгуки та вказати теми, які найбільше цікавлять, – це дасть змогу підготувати ще більше якісного та корисного контенту для подальших навчань.
