{"id":149435,"date":"2024-10-25T16:57:10","date_gmt":"2024-10-25T14:57:10","guid":{"rendered":"https:\/\/group-gac.com\/?p=149435"},"modified":"2024-11-07T11:54:28","modified_gmt":"2024-11-07T10:54:28","slug":"eligibilite-cir-etudes-cliniques-pharmacie-humaine-dispositifs-medicaux","status":"publish","type":"post","link":"https:\/\/group-gac.com\/en\/eligibility-cir-clinical-trials-human-pharmacy-medical-devices\/","title":{"rendered":"How to determine CIR eligibility for clinical trials in human pharmaceuticals and medical devices?"},"content":{"rendered":"<div data-elementor-type=\"wp-post\" data-elementor-id=\"149435\" class=\"elementor elementor-149435\" data-elementor-post-type=\"post\">\n\t\t\t\t<div class=\"elementor-element elementor-element-27b3b39 e-con-full e-flex e-con e-parent\" data-id=\"27b3b39\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-f612f21 elementor-widget elementor-widget-text-editor\" data-id=\"f612f21\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p>Clinical, epidemiological and medical device (MD) studies:\u00a0 <strong>determination and <\/strong><a href=\"https:\/\/group-gac.com\/en\/webinar-cir-cii-justify-eligibility-projects\/\" target=\"_blank\" rel=\"noopener\"><strong>justification of eligibility<\/strong><\/a><strong> at <\/strong><a href=\"https:\/\/group-gac.com\/en\/service\/cir-cii\/\" target=\"_blank\" rel=\"noopener\"><strong>CIR<\/strong><\/a><strong> such work becomes complex as we get closer to market launch<\/strong> of a product, even if its development required many years of R&amp;D.<\/p><p>In this respect <strong>BOFIP and the new <\/strong><a href=\"https:\/\/group-gac.com\/en\/cir-2024-guide-new-features\/\" target=\"_blank\" rel=\"noopener\"><strong>CIR 2024 guide<\/strong><\/a> <strong>sometimes lack clarity on eligibility<\/strong> clinical studies in human pharmaceuticals and medical devices.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-f0565c8 elementor-widget elementor-widget-heading\" data-id=\"f0565c8\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Our 2024 white paper is here to guide you! <\/h2>\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-e050ced e-flex e-con-boxed e-con e-child\" data-id=\"e050ced\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-6fbccce elementor-widget elementor-widget-text-editor\" data-id=\"6fbccce\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p>Our specialist <a href=\"https:\/\/group-gac.com\/en\/sector-health\/\" target=\"_blank\" rel=\"noopener\">health sector<\/a> and taxation of innovation offer you a <strong>complete analysis to help you understand where to place the cursor for CIR eligibility of your studies<\/strong> clinical, epidemiological, pharmaco-epidemiological and medical devices.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-f27a8c3 e-con-full e-flex e-con e-parent\" data-id=\"f27a8c3\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-9f1196f e-con-full e-flex e-con e-child\" data-id=\"9f1196f\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-029d5c4 elementor-widget elementor-widget-heading\" data-id=\"029d5c4\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">By downloading this white paper updated with 2024 news, you will discover : <\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-291bce8 elementor-widget elementor-widget-text-editor\" data-id=\"291bce8\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<ul><li>Conditions governing CIR eligibility for clinical and epidemiological studies <strong>according to phase, type and nature <\/strong><\/li><li>CIR eligibility criteria for DM studies <strong>according to their positioning<\/strong> (before or after CE marking)<\/li><li>A <strong>detailed listing of eligible and non-eligible activities <\/strong>conducted as part of clinical trials<\/li><li>CIR eligibility for <strong>personnel involved in clinical trials<\/strong><\/li><li>Of <strong>illustrative examples<\/strong> that will help you position<\/li><li>Analogy with studies conducted in the\u00a0<a href=\"https:\/\/group-gac.com\/en\/sector-agri-food\/\" target=\"_blank\" rel=\"noopener\">agri-agro sector<\/a> (<strong>dietary supplements<\/strong>, <strong>crop protection products<\/strong>) or industry <strong>cosmetics<\/strong>.<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-b1f61b3 e-con-full e-flex e-con e-child\" data-id=\"b1f61b3\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-f22bd75 e-con-full e-flex e-con e-child\" data-id=\"f22bd75\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-30010df e-flex e-con-boxed e-con e-child\" data-id=\"30010df\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-53a0eb2 elementor-widget elementor-widget-heading\" data-id=\"53a0eb2\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Fill in the form below to receive your copy instantly. <\/h3>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-ad1bd39 elementor-widget elementor-widget-html\" data-id=\"ad1bd39\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"html.default\">\n\t\t\t\t\t<iframe src=\"https:\/\/ressources.group-gac.com\/l\/1052283\/2023-12-28\/npg\" width=\"100%\" height=\"650\" type=\"text\/html\" frameborder=\"0\" allowtransparency=\"true\" style=\"border: 0\"><\/iframe>\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-287ccb2 e-flex e-con-boxed e-con e-parent\" data-id=\"287ccb2\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div 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