On the Formation of Professionally Specialized Competencies and Training of Specialists and Managers in the Pharmacovigilance System of the Marketing Authorization Holder

Abstract

Introduction. The key role in the organization of the pharmacovigilance system is played by the Marketing Authorization Holder (MAH), who monitors the safety and effectiveness at all stages of the life cycle of drugs, the need for which is determined by regulatory documents in the field of pharmacovigilance. The possibility of ensuring the required quality of the processes and the results obtained in the pharmacovigilance system of the MAH is directly related to the availability of a sufficient number of competent, qualified and trained personnel in the units that closely interact in the pharmacovigilance system of the MAH, which necessitates the formation of appropriate competencies for the implementation of procedures provided for when identifying changes in the safety profile of drugs. An integral part of the formation of competencies of employees and departments involved in the pharmacovigilance system of the MAH is training according to a specially developed program and evaluation of its effectiveness.Aim. Substantiation of the formation of professionally specialized competencies and training of employees in the pharmacovigilance system of the MAH.Materials and methods. The research materials were the results of the works of domestic scientists, data from their own research and regulatory legal acts regulating pharmacovigilance in the Russian Federation, the EAEU. Methods of sociological, logical analysis, and interactive learning were used as research methods.Results and discussion. The necessity has been established and the professionally specialized competencies of managers and specialists of the MAH in the pharmacovigilance system have been formed, for the mastery of which an educational program has been developed and training has been conducted. Information and methodological support of personnel has been introduced.Conclusion. In the course of the conducted research, it was found that training is an integral part of the organization of an employee's independent workflow. In order to achieve high-quality performance of processes and tasks related to pharmacovigilance, it is necessary to have a sufficient number of competent and trained personnel in the MAH. In order to update the acquired knowledge on pharmacovigilance, it is advisable to carry out intra-corporate training with a certain frequency.