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EBA and State Expert Center share a goal of increasing the number of clinical trials in Ukraine

11/ 02/ 2021
      On February 5, the EBA Clinical Trials Subcommittee and the experts of the State Expert Center of the Ministry of Health of Ukraine (SEC) discussed the strategic issues in the field of clinical trials, as well as the SEC’s vision and strategy of its development in Ukraine. Participants discussed existing problems of clinical trials in Ukraine and identified ways of further cooperation to address them. After all, the Subcommittee and the SEC have a common goal - to increase the number of clinical trials in Ukraine. The meeting was focused on the following issues: SECs vision to increase the number of clinical trials which includes reducing the time of examination of clinical trials materials/significant amendments, optimization of procedures. Ways to solve the problem with the approval of departmental staff and departments of higher education institutions to participate in the clinical trials. Improving the process of submitting documents and materials of clinical trials, and significant amendments in electronic form. Creating a sectoral law of Ukraine on clinical trials. Harmonizing the Ukrainian legal framework with European requirements, in particular further revision of the MOH Order №690 dated September 23, 2009, after approval of the current version of the draft amendments to Order №690, and other changes in the legislation on clinical trials that may improve the attractiveness of Ukraine for clinical trials sponsors. Thus, it was agreed on: Continuing work on changes in Order №690 to finalize this project. Discussing major changes in clinical trials legislation to consolidate efforts. Introducing regular meetings with the subcommittee to discuss problematic issues in clinical trials. The parties also considered combining the efforts of the EBA and the SEC to raise awareness of the public on clinical trials, so that to ensure proper understanding of trials’ benefits for patients access to innovative treatments. The awareness campaign will be also carried out as a part of the Trials Truth project. Iryna Magdik. EBA Executive Director, Clinical Trials Subcommittee. Increasing the number of clinical trials is a priority for the EBA, so the Subcommittee is interested in creating a single strategy for cooperation with the SEC and an action plan for further development of clinical trials in Ukraine. Mykhailo Babenko, Director of the SEC, noted that the strategic issue of increasing the clinical trials in Ukraine and optimizing the work of the SEC in all areas is directly related to digitalization and implementation of a single platform for data exchange in eCTD format. Mykhailo Lobas, Deputy Director for Clinical Affairs, announced plans for the development of clinical trials in Ukraine. The Subcommittee is grateful to the SEC management for meeting and discussing joint actions for the development of clinical trials in Ukraine.  
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On February 5, the EBA Clinical Trials Subcommittee and the experts of the State Expert Center of the Ministry of Health of Ukraine (SEC) discussed the strategic issues in the field of clinical trials, as well as the SEC’s vision and strategy of its development in Ukraine. Participants discussed existing problems of clinical trials in Ukraine and identified ways of further cooperation to address them. After all, the Subcommittee and the SEC have a common goal – to increase the number of clinical trials in Ukraine.

The meeting was focused on the following issues:

  • SEC’s vision to increase the number of clinical trials which includes reducing the time of examination of clinical trials materials/significant amendments, optimization of procedures.
  • Ways to solve the problem with the approval of departmental staff and departments of higher education institutions to participate in the clinical trials.
  • Improving the process of submitting documents and materials of clinical trials, and significant amendments in electronic form.
  • Creating a sectoral law of Ukraine on clinical trials.
  • Harmonizing the Ukrainian legal framework with European requirements, in particular further revision of the MOH Order №690 dated September 23, 2009, after approval of the current version of the draft amendments to Order №690, and other changes in the legislation on clinical trials that may improve the attractiveness of Ukraine for clinical trials sponsors.

Thus, it was agreed on:

  • Continuing work on changes in Order №690 to finalize this project.
  • Discussing major changes in clinical trials legislation to consolidate efforts.
  • Introducing regular meetings with the subcommittee to discuss problematic issues in clinical trials.

The parties also considered combining the efforts of the EBA and the SEC to raise awareness of the public on clinical trials, so that to ensure proper understanding of trials’ benefits for patients’ access to innovative treatments. The awareness campaign will be also carried out as a part of the Trials Truth project.

Iryna Magdik EBA Executive Director, Clinical Trials Subcommittee
Increasing the number of clinical trials is a priority for the EBA, so the Subcommittee is interested in creating a single strategy for cooperation with the SEC and an action plan for further development of clinical trials in Ukraine.

Mykhailo Babenko, Director of the SEC, noted that the strategic issue of increasing the clinical trials in Ukraine and optimizing the work of the SEC in all areas is directly related to digitalization and implementation of a single platform for data exchange in eCTD format. Mykhailo Lobas, Deputy Director for Clinical Affairs, announced plans for the development of clinical trials in Ukraine.

The Subcommittee is grateful to the SEC management for meeting and discussing joint actions for the development of clinical trials in Ukraine.

 

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