<\/p>\n
On 20 May, on International Clinical Trials Day \u2014 a professional occasion that unites the community around the development of science, innovation, and patient access to modern treatment \u2014 representatives of the State Expert Centre of the Ministry of Health of Ukraine (SEC) and the Clinical Trials Subcommittee of the European Business Association held a working meeting. Symbolically, on this very day, the participants focused on practical cooperation aimed at further improving the conditions for the approval and conduct of clinical trials in Ukraine.<\/p>\n
The meeting focused on current issues related to the electronic submission of applications and supporting documents for clinical trials and substantial amendments through the applicant\u2019s account within the Ministry of Health\u2019s \u201cSingle Window\u201d system.<\/p>\n
The event brought together representatives of companies operating in the field of clinical trials in Ukraine, as well as Iryna Magdik, Executive Director of the Association\u2019s Clinical Trials Subcommittee. Representing the SEC were Yevheniia Ishkova, Deputy Director for Health Technology Assessment and Clinical Trials, experts responsible for reviewing clinical trial materials, and software specialists.<\/p>\n
A key part of the meeting was a practical demonstration of the electronic submission system\u2019s functionality. SEC representatives presented the process of submitting applications and supporting documents in a test environment, helping participants better understand the system\u2019s logic, current capabilities, and functionality.<\/p>\n
During the open discussion, participants addressed practical aspects of working with the platform, while SEC representatives provided clarifications and recommendations to facilitate its use.<\/p>\n
Participants also shared their experience of using the system and outlined the main issues arising during the electronic submission of documents, particularly regarding the use of electronic signatures, the authority of authorised representatives, and requirements for powers of attorney.<\/p>\n
The discussion additionally covered technical and procedural nuances, including requirements for file formats and submission media, the use of reference directories and actions in cases where necessary data is unavailable, as well as difficulties related to applicant status verification and document submission. Participants also discussed the further development of the system\u2019s functionality, including the possibility of selecting several substantial amendments simultaneously.<\/p>\n
Following the meeting, the parties agreed to continue their cooperation to further improve the electronic functionality of the system. In particular, the SEC expects users of the system \u2014 company representatives \u2014 to provide feedback on technical issues or difficulties encountered during use, enabling prompt review and further enhancement of the platform.<\/p>\n
The Association expresses its gratitude to the management and specialists of the State Expert Centre of the Ministry of Health of Ukraine for their openness to dialogue, the practical format of cooperation, and their willingness to work jointly on the digitalisation of processes and the improvement of the regulatory environment for clinical trials in Ukraine.<\/p>\n
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On 20 May, on International Clinical Trials Day \u2014 a professional occasion that unites the community around the development of science, innovation, and patient access to modern treatment \u2014 representatives of the State Expert Centre of the Ministry of Health of Ukraine (SEC) and the Clinical Trials Subcommittee of the European Business Association held a […]<\/p>\n","protected":false},"author":33544,"featured_media":745623,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"inline_featured_image":false},"categories":[4,5,22],"tags":[],"yoast_head":"\n