Representatives of Applicants had the opportunity on 17.01.2020 and 21.01.2020 to take part in consultative and introductory training sessions on the creation and functionality of the Applicant’s personal electronic account (AEA).
Training participants were provided with information on the use of the specified module in the Automated Pharmacovigilance Information System (AISF). This information was presented by staff of the Pharmacovigilance Directorate of the State Expert Center of the Ministry of Health together with the developers of the AISF, LLC “INSTITUTE FOR THE DEVELOPMENT OF INFORMATION SYSTEMS”.
155 representatives of Applicants took part in the trainings; they are interested in creating EKZ and already have the ability, or plan, to submit information on adverse reactions to medicinal products, including vaccines/tuberculin, as XML files in R2 or R3 formats.
Starting from 10 January 2020, Applicants can submit to the State Expert Center of the Ministry of Health of Ukraine reports of adverse reactions to medicinal products, including vaccines/tuberculin, marketed in Ukraine, through the established Applicant’s Electronic Cabinet (EKZ).
At the trainings, representatives of Applicants were familiarized with the conditions, sequence of actions and measures required for the creation and functionality of the Applicant's Electronic Cabinet.
Also, the attention of the Applicants’ representatives was focused on the terms of providing services for access to the AISF through the ECZ created by the Applicant, for the purpose of monitoring and analyzing information on adverse reactions and/or lack of efficacy of medicinal products, including vaccines/tuberculin, that the applicant places on the Ukrainian market.
At the end of the event, in a live discussion between representatives of Applicants and employees of the Pharmacovigilance Directorate of the State Expert Center of the MoH and the developers of the AISF, LLC “INSTITUTE OF INFORMATION SYSTEMS DEVELOPMENT,” the problems that may arise in this process and ways to resolve them were discussed, and answers to all questions were also provided.
The consultative and familiarization trainings held were listened to with great interest by representatives of Applicants, and we believe that in the future they will make it possible to avoid problems in the creation and use of EKZ in the AISF.
