{"id":774979,"date":"2021-02-11T15:22:42","date_gmt":"2021-02-11T13:22:42","guid":{"rendered":""},"modified":"2021-02-15T10:46:56","modified_gmt":"2021-02-15T08:46:56","slug":"zbilshennya-kilkosti-klinichnyh-doslidzhen-v-ukrayini-spilna-meta-eba-i-dets","status":"publish","type":"post","link":"https:\/\/new.eba.com.ua\/en\/zbilshennya-kilkosti-klinichnyh-doslidzhen-v-ukrayini-spilna-meta-eba-i-dets\/","title":{"rendered":"EBA and State Expert Center share a goal of increasing the number of clinical trials in Ukraine"},"content":{"rendered":"<div class=\"slider__outer-container\">\n\t<div class=\"slider\">\n\n\t\t<div class=\"slider__container\">\n\t\t\t\t\t\t\t<div data-caption=\"\" data-src=\"https:\/\/new.eba.com.ua\/wp-content\/uploads\/2021\/02\/thumbnail_image007.jpg\" data-full-src=\"https:\/\/new.eba.com.ua\/wp-content\/uploads\/2021\/02\/thumbnail_image007.jpg\">\n\t\t\t\t\t<div class=\"slide-inner\" style=\"background-image: url(https:\/\/new.eba.com.ua\/wp-content\/uploads\/2021\/02\/thumbnail_image007.jpg)\">\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div data-caption=\"\" data-src=\"https:\/\/new.eba.com.ua\/wp-content\/uploads\/2021\/02\/thumbnail_image006.jpg\" data-full-src=\"https:\/\/new.eba.com.ua\/wp-content\/uploads\/2021\/02\/thumbnail_image006.jpg\">\n\t\t\t\t\t<div class=\"slide-inner\" style=\"background-image: url(https:\/\/new.eba.com.ua\/wp-content\/uploads\/2021\/02\/thumbnail_image006.jpg)\">\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\t<div class=\"slider__panel\">\n\n\t\t\t<div class=\"slider__info-container\">\n\n\t\t\t\t<div class=\"slider__counters\">\n\t\t\t\t\t<div class=\"container\">\n\t\t\t\t\t\t<span class=\"slider__counter slider__counter--current\">01<\/span>\/<span class=\"slider__counter slider__counter--total\"><\/span>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\n\t\t\t\t<div class=\"slider__title\">\n\t\t\t\t\t<div class=\"container\">\n\t\t\t\t\t\t<span class=\"slider__title__text\" style=\"display:none\">Photo: <\/span>\n\t\t\t\t\t\t<span class=\"slider__title__description\"><\/span>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\n\t\t\t<\/div>\n\n\t\t\t<div class=\"slider__nav slider__nav--prev icon icon-long-arrow\">\n\t\t\t\t<span class=\"icon icon-arrow-l-thin\"><\/span>\n\t\t\t<\/div>\n\t\t\t<div class=\"slider__nav slider__nav--next icon icon-long-arrow arrow-right\">\n\t\t\t<\/div>\n\n\t\t\t<div class=\"slider__fullscreen icon icon-full-size js_slick-fullscreen\"><\/div>\n\n\t\t<\/div>\n\n\t\t<span class=\"close-full-size\"><\/span>\n\n\t<\/div>\n<\/div>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<p><span data-preserver-spaces=\"true\">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\u2019s 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 &#8211; to increase the number of clinical trials in Ukraine.<\/span><\/p>\n<p><strong>The meeting was focused on the following issues:<\/strong><\/p>\n<ul>\n<li><span data-preserver-spaces=\"true\">SEC&#8217;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.<\/span><\/li>\n<li><span data-preserver-spaces=\"true\">Ways to solve the problem with the approval of departmental staff and departments of higher education institutions to participate in the clinical trials.<\/span><\/li>\n<li><span data-preserver-spaces=\"true\">Improving the process of submitting documents and materials of clinical trials, and significant amendments in electronic form.<\/span><\/li>\n<li><span data-preserver-spaces=\"true\">Creating a sectoral law of Ukraine on clinical trials.<\/span><\/li>\n<li><span data-preserver-spaces=\"true\">Harmonizing the Ukrainian legal framework with European requirements, in particular further revision of the MOH Order \u2116690 dated September 23, 2009, after approval of the current version of the draft amendments to Order \u2116690, and other changes in the legislation on clinical trials that may improve the attractiveness of Ukraine for clinical trials sponsors.<\/span><\/li>\n<\/ul>\n<p><span data-preserver-spaces=\"true\">Thus, it was agreed on:<\/span><\/p>\n<ul>\n<li><span data-preserver-spaces=\"true\">Continuing work on changes in Order \u2116690 to finalize this project.<\/span><\/li>\n<li><span data-preserver-spaces=\"true\">Discussing major changes in clinical trials legislation to consolidate efforts.<\/span><\/li>\n<li><span data-preserver-spaces=\"true\">Introducing regular meetings with the subcommittee to discuss problematic issues in clinical trials.<\/span><\/li>\n<\/ul>\n<p><span data-preserver-spaces=\"true\">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\u2019 benefits for patients&#8217; access to innovative treatments. The awareness campaign will be also carried out as a part of\u00a0<\/span><a class=\"editor-rtfLink\" href=\"https:\/\/trialstruth.com.ua\/\" target=\"_blank\" rel=\"noopener\"><span data-preserver-spaces=\"true\">the Trials Truth<\/span><\/a><span data-preserver-spaces=\"true\">\u00a0project.<\/span><\/p>\n\t<div class=\"blockquote-custom-big animate-block animate-block--before animate-block--to-right\">\n\n\t\t<div class=\"quote-header\">\n\t\t\t\t\t\t<img decoding=\"async\" src=\"\">\n\n\t\t\t\t\t\t\t<span class=\"name\">Iryna Magdik<\/span>\n\t\t\t\n\t\t\t\t\t\t\t<span class=\"position\">EBA Executive Director, Clinical Trials Subcommittee<\/span>\n\t\t\t\t\t<\/div>\n\n\t\t\t\t\t<blockquote class=\"blockquote-custom\">\n\t\t\t\tIncreasing 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.\n\t\t\t<\/blockquote>\n\t\t\t\t\n\t<\/div>\n\n<p><strong><span data-preserver-spaces=\"true\">Mykhailo Babenko<\/span><\/strong><span data-preserver-spaces=\"true\">, 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.\u00a0<\/span><strong><span data-preserver-spaces=\"true\">Mykhailo Lobas<\/span><\/strong><span data-preserver-spaces=\"true\">, Deputy Director for Clinical Affairs, announced plans for the development of clinical trials in Ukraine.<\/span><\/p>\n<p><span data-preserver-spaces=\"true\">The Subcommittee is grateful to the SEC management for meeting and discussing joint actions for the development of clinical trials in Ukraine.<\/span><\/p>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>&nbsp; &nbsp; 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\u2019s vision and strategy of its development in Ukraine. Participants discussed existing problems of clinical [&hellip;]<\/p>\n","protected":false},"author":4489,"featured_media":314297,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"inline_featured_image":false,"footnotes":""},"categories":[15564,15563],"tags":[],"class_list":["post-774979","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-lobbying-news-en","category-main-news-en"],"_links":{"self":[{"href":"https:\/\/new.eba.com.ua\/en\/wp-json\/wp\/v2\/posts\/774979","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/new.eba.com.ua\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/new.eba.com.ua\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/new.eba.com.ua\/en\/wp-json\/wp\/v2\/users\/4489"}],"replies":[{"embeddable":true,"href":"https:\/\/new.eba.com.ua\/en\/wp-json\/wp\/v2\/comments?post=774979"}],"version-history":[{"count":0,"href":"https:\/\/new.eba.com.ua\/en\/wp-json\/wp\/v2\/posts\/774979\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/new.eba.com.ua\/en\/wp-json\/wp\/v2\/media\/314297"}],"wp:attachment":[{"href":"https:\/\/new.eba.com.ua\/en\/wp-json\/wp\/v2\/media?parent=774979"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/new.eba.com.ua\/en\/wp-json\/wp\/v2\/categories?post=774979"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/new.eba.com.ua\/en\/wp-json\/wp\/v2\/tags?post=774979"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}