Given the importance of the topic of post-registration surveillance of medicinal products in Ukraine, the Center has already held a second seminar within the framework of professional development (PD) of medical and pharmaceutical workers, devoted to current issues of pharmacovigilance. The training was organized by the Methodological and Scientific-Practical Work Agency in cooperation with specialists of the Center's Pharmacovigilance Department.
The main objective is to deepen the knowledge and skills of doctors and pharmacists regarding the proper conduct of pharmacovigilance for medicinal products in accordance with the current by-laws and regulations harmonized with EU legislation and with the application of international standards.
The program addressed the following key issues:
- rights and obligations of medical/pharmaceutical workers in the course of pharmacovigilance activities;
- informing the Center about lack of efficacy/adverse reactions/NPPI for medicinal products through the AISF National Reporting System;
- risk analysis of medicinal products, completing the package leaflet with regard to their safety;
- specifics of completing and submitting AEFI report forms after vaccination campaigns.
The lecture course was delivered by Tetiana Bashkatova, Director of the Pharmacovigilance Department of the Center, Maryna Lorynets, Head of the Division for Safety Information Monitoring and Management and PSUR Evaluation, and Valeriia Vasylieva, Head of the Division for Monitoring of Adverse Events Following the Use of Medicinal Products.
Together with the Center's specialists, participants were able to deepen their knowledge of:
- pharmacovigilance systems in Ukraine;
- completing adverse reaction report forms for a medicinal product in the AISF system using specific examples;
- types of risks of using a medicinal product and how they are presented in the package leaflet;
- benefit/risk analysis processes for medicinal products;
- specifics of completing report forms on adverse events following immunization (AEFI), and assessing the causal relationship between AEFI and a vaccine using specific examples;
- international approaches to AEFI reporting systems, using the United States and Europe as examples.
The course concluded with online testing; successful completion entitles participants to receive certificates as well as +10 points toward the total mandatory points required for annual attestation.
Summing up the seminar, the head of the Agency, Doctor of Pharmaceutical Sciences, Professor Oleksandr Hudzenko emphasized the importance of continuous training of healthcare workers, thanked the speakers and participants, and encouraged them to join the Center’s further professional development training.
According to him, seminars on preclinical and clinical trials of medicinal products, as well as on state health technology assessment, are planned for the coming month. The training schedule and registration for participation are available on the Center’s separate web page https://bpr.dec.gov.ua/ or via the Agency’s contacts: tel. (044) 202-17-00, e-mail: bpr@dec.gov.ua
Please note that the State Expert Center of the Ministry of Health of Ukraine has been a provider in the continuing professional development (CPD) system for healthcare workers since February 2023.
The topics of the training are determined by the statutory tasks and concern the following areas:
- preclinical study and clinical trials of medicinal products;
- state registration of medicinal products, bioavailability, and bioequivalence;
- post-registration surveillance of medicinal products, pharmacovigilance;
- state health technology assessment;
- standardization in the field of medicinal product circulation, medical care, provision of medical services;
- development of a system of rational pharmacotherapy, including a formulary system, and improvement of reimbursement and pricing mechanisms for medicinal products.
By choosing training at the Center, you receive:
- unique topics found nowhere else on the market;
- quality content adapted to the needs of target audiences;
- an effective combination of theory and practice;
- qualified and competent speakers at the level of a national regulatory authority;
- a convenient online format that allows you to study without interrupting your work;
- certificates and +10 points for each seminar toward attestation.
We invite you to deepen your professional competencies together with us!
