As a Professional development provider (No. 1293), the Center held its first seminar for medical and pharmaceutical professionals, devoted to current issues of pharmacovigilance. The training took place online.
The event was opened by Oleksandr Pavlovych Hudzenko, Head of the Agency for Methodological and Scientific-Practical Work of the Center, Doctor of Pharmaceutical Sciences, Professor, Honored Worker of Ukraine. He welcomed the participants on the opportunity to improve their competence at the Center, introduced the training program, the speakers, the procedure for taking the test, its assessment and the receipt of certificates. He announced further topics of CPD trainings at the Center and invited them to join.
“Each seminar in the Center's Professional Development cycle is worth 10 points toward the total mandatory number of points that a medical/pharmaceutical professional must earn for subsequent successful certification,” he emphasized. “By choosing our seminars, you have the opportunity to receive information first-hand from the Center's specialists and experts who are directly responsible for the functioning of these processes in the country, and to gain not only theoretical knowledge but also practical skills. And the convenient online format that we offer allows you to study without interrupting your work,” stressed O. Hudzenko.
The first professional development seminar was devoted to current issues of pharmacovigilance, namely:
- rules for submitting to the Center report forms on adverse reactions to medicinal products. The AISF national reporting system.
- filling the instructions for medical use of medicinal products with regard to their safety of use.
- vaccination campaigns, specifics of completing and submitting AEFI notification cards after vaccinations are carried out.
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.
In her speech, Tetiana Bashkatova informed about the pharmacovigilance system in Ukraine and its components. She detailed the rights and obligations of medical/pharmaceutical workers within the framework of pharmacovigilance, and their role and the importance of reporting adverse reactions/lack of efficacy/NNPI.
She demonstrated the process of completing the adverse drug reaction report form in the AISF system. Together with the participants, she went through in detail the provision of information for each section, and practical examples were discussed.
Maryna Lorynets described the types of risks and how they are reflected in the instructions for medical use of a medicinal product. She reminded participants of the need for regular review of the instructions and indicated the sources of safety information when analyzing the use of medicinal products. She presented the results of benefit/risk analyses of medicinal products, which the Center regularly publishes for applicants, healthcare professionals, and patients.
In her presentation, Valeriia Vasylieva focused on approaches to pharmacovigilance of vaccines in Ukraine in accordance with the requirements of current legislation. She spoke about the specifics of completing the report form on cases of adverse events following immunization (AEFI) and the assessment of the causal relationship between AEFI and the vaccine. She drew attention to AEFI reporting systems in the USA (VAERS) and Europe (EUDRAVIGILANCE). She presented the results of immunization campaigns in Ukraine for 2021-2023.
At the end of the course, seminar participants received access to online testing, the successful completion of which made it possible to obtain certificates with awarded professional development points.
Please note that the State Expert Center of the Ministry of Health of Ukraine obtained the status of a provider in the system of continuous professional development (CPD) of healthcare professionals on February 21, 2023. The training topics are determined by the statutory tasks and relate to the following areas:
- preclinical study and clinical trials of medicinal products
- state registration of medicinal products, bioavailability and bioequivalence
- implementation of 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.
Training is held in the form of seminars, scientific and practical conferences, trainings, professional (thematic) schools, and online discussions.
You can learn more about training within the Center's professional development system, view the seminar calendar, and register to participate on a separate web page of the Center at the link https://bpr.dec.gov.ua/
Contact details: tel. (044) 202-17-00, e-mail: bpr@dec.gov.ua
Everyone interested is welcome!
