{"id":227,"date":"2023-04-20T17:09:34","date_gmt":"2023-04-20T15:09:34","guid":{"rendered":"https:\/\/ceiso.fr\/en\/?page_id=227"},"modified":"2023-04-20T17:13:30","modified_gmt":"2023-04-20T15:13:30","slug":"guides-and-recommendations","status":"publish","type":"page","link":"https:\/\/ceiso.fr\/en\/guides-and-recommendations\/","title":{"rendered":"Guides and recommendations"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"227\" class=\"elementor elementor-227\">\n\t\t\t\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-030ade0 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"030ade0\" data-element_type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-b93b205\" data-id=\"b93b205\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-d9b540c elementor-widget elementor-widget-heading\" data-id=\"d9b540c\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.12.2 - 23-04-2023 *\/\n.elementor-heading-title{padding:0;margin:0;line-height:1}.elementor-widget-heading .elementor-heading-title[class*=elementor-size-]>a{color:inherit;font-size:inherit;line-height:inherit}.elementor-widget-heading .elementor-heading-title.elementor-size-small{font-size:15px}.elementor-widget-heading .elementor-heading-title.elementor-size-medium{font-size:19px}.elementor-widget-heading .elementor-heading-title.elementor-size-large{font-size:29px}.elementor-widget-heading .elementor-heading-title.elementor-size-xl{font-size:39px}.elementor-widget-heading .elementor-heading-title.elementor-size-xxl{font-size:59px}<\/style><h2 class=\"elementor-heading-title elementor-size-default\">ICH Guidelines for Good Clinical Practices E6 (R2)<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-6b38c41 elementor-tabs-view-vertical tabs-custom elementor-widget elementor-widget-tabs\" data-id=\"6b38c41\" data-element_type=\"widget\" data-widget_type=\"tabs.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.12.2 - 23-04-2023 *\/\n.elementor-widget-tabs.elementor-tabs-view-vertical .elementor-tabs-wrapper{width:25%;flex-shrink:0}.elementor-widget-tabs.elementor-tabs-view-vertical .elementor-tab-desktop-title.elementor-active{border-right-style:none}.elementor-widget-tabs.elementor-tabs-view-vertical .elementor-tab-desktop-title.elementor-active:after,.elementor-widget-tabs.elementor-tabs-view-vertical .elementor-tab-desktop-title.elementor-active:before{height:999em;width:0;right:0;border-right-style:solid}.elementor-widget-tabs.elementor-tabs-view-vertical .elementor-tab-desktop-title.elementor-active:before{top:0;transform:translateY(-100%)}.elementor-widget-tabs.elementor-tabs-view-vertical .elementor-tab-desktop-title.elementor-active:after{top:100%}.elementor-widget-tabs.elementor-tabs-view-horizontal .elementor-tab-desktop-title{display:table-cell}.elementor-widget-tabs.elementor-tabs-view-horizontal .elementor-tab-desktop-title.elementor-active{border-bottom-style:none}.elementor-widget-tabs.elementor-tabs-view-horizontal .elementor-tab-desktop-title.elementor-active:after,.elementor-widget-tabs.elementor-tabs-view-horizontal .elementor-tab-desktop-title.elementor-active:before{bottom:0;height:0;width:999em;border-bottom-style:solid}.elementor-widget-tabs.elementor-tabs-view-horizontal .elementor-tab-desktop-title.elementor-active:before{right:100%}.elementor-widget-tabs.elementor-tabs-view-horizontal .elementor-tab-desktop-title.elementor-active:after{left:100%}.elementor-widget-tabs .elementor-tab-content,.elementor-widget-tabs .elementor-tab-title,.elementor-widget-tabs .elementor-tab-title:after,.elementor-widget-tabs .elementor-tab-title:before,.elementor-widget-tabs .elementor-tabs-content-wrapper{border:1px #d5d8dc}.elementor-widget-tabs .elementor-tabs{text-align:left}.elementor-widget-tabs .elementor-tabs-wrapper{overflow:hidden}.elementor-widget-tabs .elementor-tab-title{cursor:pointer;outline:var(--focus-outline,none)}.elementor-widget-tabs .elementor-tab-desktop-title{position:relative;padding:20px 25px;font-weight:700;line-height:1;border:solid transparent}.elementor-widget-tabs .elementor-tab-desktop-title.elementor-active{border-color:#d5d8dc}.elementor-widget-tabs .elementor-tab-desktop-title.elementor-active:after,.elementor-widget-tabs .elementor-tab-desktop-title.elementor-active:before{display:block;content:\"\";position:absolute}.elementor-widget-tabs .elementor-tab-desktop-title:focus-visible{border:1px solid #000}.elementor-widget-tabs .elementor-tab-mobile-title{padding:10px;cursor:pointer}.elementor-widget-tabs .elementor-tab-content{padding:20px;display:none}@media (max-width:767px){.elementor-tabs .elementor-tab-content,.elementor-tabs .elementor-tab-title{border-style:solid solid none}.elementor-tabs .elementor-tabs-wrapper{display:none}.elementor-tabs .elementor-tabs-content-wrapper{border-bottom-style:solid}.elementor-tabs .elementor-tab-content{padding:10px}}@media (min-width:768px){.elementor-widget-tabs.elementor-tabs-view-vertical .elementor-tabs{display:flex}.elementor-widget-tabs.elementor-tabs-view-vertical .elementor-tabs-wrapper{flex-direction:column}.elementor-widget-tabs.elementor-tabs-view-vertical .elementor-tabs-content-wrapper{flex-grow:1;border-style:solid solid solid none}.elementor-widget-tabs.elementor-tabs-view-horizontal .elementor-tab-content{border-style:none solid solid}.elementor-widget-tabs.elementor-tabs-alignment-center .elementor-tabs-wrapper,.elementor-widget-tabs.elementor-tabs-alignment-end .elementor-tabs-wrapper,.elementor-widget-tabs.elementor-tabs-alignment-stretch .elementor-tabs-wrapper{display:flex}.elementor-widget-tabs.elementor-tabs-alignment-center .elementor-tabs-wrapper{justify-content:center}.elementor-widget-tabs.elementor-tabs-alignment-end .elementor-tabs-wrapper{justify-content:flex-end}.elementor-widget-tabs.elementor-tabs-alignment-stretch.elementor-tabs-view-horizontal .elementor-tab-title{width:100%}.elementor-widget-tabs.elementor-tabs-alignment-stretch.elementor-tabs-view-vertical .elementor-tab-title{height:100%}.elementor-tabs .elementor-tab-mobile-title{display:none}}<\/style>\t\t<div class=\"elementor-tabs\">\n\t\t\t<div class=\"elementor-tabs-wrapper\" role=\"tablist\" >\n\t\t\t\t\t\t\t\t\t<div id=\"elementor-tab-title-1121\" class=\"elementor-tab-title elementor-tab-desktop-title\" aria-selected=\"true\" data-tab=\"1\" role=\"tab\" tabindex=\"0\" aria-controls=\"elementor-tab-content-1121\" aria-expanded=\"false\">GCP (BCP)<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t\t<div class=\"elementor-tabs-content-wrapper\" role=\"tablist\" aria-orientation=\"vertical\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-tab-title elementor-tab-mobile-title\" aria-selected=\"true\" data-tab=\"1\" role=\"tab\" tabindex=\"0\" aria-controls=\"elementor-tab-content-1121\" aria-expanded=\"false\">GCP (BCP)<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-1121\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"1\" role=\"tabpanel\" aria-labelledby=\"elementor-tab-title-1121\" tabindex=\"0\" hidden=\"false\"><p><span style=\"color: #023e7d; font-weight: bold;\">Date :<\/span> 15\/12\/2016 (Final adoption by the CHMP) &#8211; June 14, 2017 (Effective date)<\/p><p><span style=\"color: #023e7d; font-weight: bold;\">Author :<\/span> ICH<\/p><p><span style=\"color: #023e7d; font-weight: bold;\">Goal\/scope : <\/span>Internationally recognized recommendations for good clinical practices in biomedical research.<\/p><p><a href=\"https:\/\/www.ema.europa.eu\/en\/ich-e6-r2-good-clinical-practice-scientific-guideline\">https:\/\/www.ema.europa.eu\/en\/ich-e6-r2-good-clinical-practice-scientific-guideline<\/a><\/p><p>We are at your disposal to assist you in understanding and implementing these recommendations &#8211; do not hesitate to contact us: <a href=\"mailto:contact@ceiso.fr\">contact@ceiso.fr<\/a><\/p><\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-d587ce0 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"d587ce0\" data-element_type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-1d1f87e\" data-id=\"1d1f87e\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-57f05d3 elementor-widget elementor-widget-heading\" data-id=\"57f05d3\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">MDCG Guides<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-41a3981 elementor-tabs-view-vertical tabs-custom elementor-widget elementor-widget-tabs\" data-id=\"41a3981\" data-element_type=\"widget\" data-widget_type=\"tabs.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-tabs\">\n\t\t\t<div class=\"elementor-tabs-wrapper\" role=\"tablist\" >\n\t\t\t\t\t\t\t\t\t<div id=\"elementor-tab-title-6881\" class=\"elementor-tab-title elementor-tab-desktop-title\" aria-selected=\"true\" data-tab=\"1\" role=\"tab\" tabindex=\"0\" aria-controls=\"elementor-tab-content-6881\" aria-expanded=\"false\">2021-24<\/div>\n\t\t\t\t\t\t\t\t\t<div id=\"elementor-tab-title-6882\" class=\"elementor-tab-title elementor-tab-desktop-title\" aria-selected=\"false\" data-tab=\"2\" role=\"tab\" tabindex=\"-1\" aria-controls=\"elementor-tab-content-6882\" aria-expanded=\"false\">2020-5<\/div>\n\t\t\t\t\t\t\t\t\t<div id=\"elementor-tab-title-6883\" class=\"elementor-tab-title elementor-tab-desktop-title\" aria-selected=\"false\" data-tab=\"3\" role=\"tab\" tabindex=\"-1\" aria-controls=\"elementor-tab-content-6883\" aria-expanded=\"false\">2020-1<\/div>\n\t\t\t\t\t\t\t\t\t<div id=\"elementor-tab-title-6884\" class=\"elementor-tab-title elementor-tab-desktop-title\" aria-selected=\"false\" data-tab=\"4\" role=\"tab\" tabindex=\"-1\" aria-controls=\"elementor-tab-content-6884\" aria-expanded=\"false\">2022-16<\/div>\n\t\t\t\t\t\t\t\t\t<div id=\"elementor-tab-title-6885\" class=\"elementor-tab-title elementor-tab-desktop-title\" aria-selected=\"false\" data-tab=\"5\" role=\"tab\" tabindex=\"-1\" aria-controls=\"elementor-tab-content-6885\" aria-expanded=\"false\">2022-21<\/div>\n\t\t\t\t\t\t\t\t\t<div id=\"elementor-tab-title-6886\" class=\"elementor-tab-title elementor-tab-desktop-title\" aria-selected=\"false\" data-tab=\"6\" role=\"tab\" tabindex=\"-1\" aria-controls=\"elementor-tab-content-6886\" aria-expanded=\"false\">Guides - Approved documents by MDCG and other guides<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t\t<div class=\"elementor-tabs-content-wrapper\" role=\"tablist\" aria-orientation=\"vertical\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-tab-title elementor-tab-mobile-title\" aria-selected=\"true\" data-tab=\"1\" role=\"tab\" tabindex=\"0\" aria-controls=\"elementor-tab-content-6881\" aria-expanded=\"false\">2021-24<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-6881\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"1\" role=\"tabpanel\" aria-labelledby=\"elementor-tab-title-6881\" tabindex=\"0\" hidden=\"false\"><p><span style=\"color: #023e7d; font-weight: bold;\">Date :<\/span> 2021<\/p><p><span style=\"color: #023e7d; font-weight: bold;\">Author :<\/span> MDCG<\/p><p><span style=\"color: #023e7d; font-weight: bold;\">Goal\/scope :<\/span> Guidance on classification of medical devices.<\/p><\/div>\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-tab-title elementor-tab-mobile-title\" aria-selected=\"false\" data-tab=\"2\" role=\"tab\" tabindex=\"-1\" aria-controls=\"elementor-tab-content-6882\" aria-expanded=\"false\">2020-5<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-6882\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"2\" role=\"tabpanel\" aria-labelledby=\"elementor-tab-title-6882\" tabindex=\"0\" hidden=\"hidden\"><p><span style=\"color: #023e7d; font-weight: bold;\">Date :<\/span> 2020<\/p><p><span style=\"color: #023e7d; font-weight: bold;\">Author :<\/span> MDCG<\/p><p><span style=\"color: #023e7d; font-weight: bold;\">Goal\/scope :<\/span> Guidance on clinical evaluation \u2013 Equivalence.<\/p><\/div>\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-tab-title elementor-tab-mobile-title\" aria-selected=\"false\" data-tab=\"3\" role=\"tab\" tabindex=\"-1\" aria-controls=\"elementor-tab-content-6883\" aria-expanded=\"false\">2020-1<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-6883\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"3\" role=\"tabpanel\" aria-labelledby=\"elementor-tab-title-6883\" tabindex=\"0\" hidden=\"hidden\"><p><span style=\"color: #023e7d; font-weight: bold;\">Date :<\/span> 2020<\/p><p><span style=\"color: #023e7d; font-weight: bold;\">Author :<\/span> MDCG<\/p><p><span style=\"color: #023e7d; font-weight: bold;\">Goal\/scope :<\/span> Guidance on clinical evaluation (MDR) \/ Performance evaluation (IVDR) of medical device software.<\/p><\/div>\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-tab-title elementor-tab-mobile-title\" aria-selected=\"false\" data-tab=\"4\" role=\"tab\" tabindex=\"-1\" aria-controls=\"elementor-tab-content-6884\" aria-expanded=\"false\">2022-16<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-6884\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"4\" role=\"tabpanel\" aria-labelledby=\"elementor-tab-title-6884\" tabindex=\"0\" hidden=\"hidden\"><p><span style=\"color: #023e7d; font-weight: bold;\">Date :<\/span> 2022<\/p><p><span style=\"color: #023e7d; font-weight: bold;\">Author :<\/span> MDCG<\/p><p><span style=\"color: #023e7d; font-weight: bold;\">Goal\/scope :<\/span> Guidance on Authorized Representatives Regulation (EU) 2017\/745 and Regulation (EU) 2017\/746.<\/p><\/div>\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-tab-title elementor-tab-mobile-title\" aria-selected=\"false\" data-tab=\"5\" role=\"tab\" tabindex=\"-1\" aria-controls=\"elementor-tab-content-6885\" aria-expanded=\"false\">2022-21<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-6885\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"5\" role=\"tabpanel\" aria-labelledby=\"elementor-tab-title-6885\" tabindex=\"0\" hidden=\"hidden\"><p><span style=\"color: #023e7d; font-weight: bold;\">Date :<\/span> 2022<\/p><p><span style=\"color: #023e7d; font-weight: bold;\">Author :<\/span> MDCG<\/p><p><span style=\"color: #023e7d; font-weight: bold;\">Goal\/scope :<\/span> Guidance on Periodic Safety Update Report (PSUR) according to Regulation (EU) 2017\/745.<\/p><\/div>\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-tab-title elementor-tab-mobile-title\" aria-selected=\"false\" data-tab=\"6\" role=\"tab\" tabindex=\"-1\" aria-controls=\"elementor-tab-content-6886\" aria-expanded=\"false\">Guides - Approved documents by MDCG and other guides<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-6886\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"6\" role=\"tabpanel\" aria-labelledby=\"elementor-tab-title-6886\" tabindex=\"0\" hidden=\"hidden\"><p>All MDCG guides are available at the following address:<\/p><p><a href=\"https:\/\/health.ec.europa.eu\/medical-devices-sector\/new-regulations\/guidance-mdcg-endorsed-documents-and-other-guidance_en\">https:\/\/health.ec.europa.eu\/medical-devices-sector\/new-regulations\/guidance-mdcg-endorsed-documents-and-other-guidance_en<\/a><\/p><p>This page provides a series of documents to help stakeholders apply Regulation (EU) 2017\/745 on medical devices (MDR). Most of the documents on this page are approved by the Medical Device Coordination Group (MDCG) in accordance with Article 105 of the MDR and Article 99 of the IVDR. They are written in collaboration with interested parties represented in the various groups and named according to the following format: &#8220;MDCG Year-Number-revision&#8221;.<\/p><p>We are available to assist you in understanding and applying these recommendations &#8211; do not hesitate to contact us: <a href=\"contact@ceiso.fr\">contact@ceiso.fr<\/a>.<\/p><\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-b45b7f8 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"b45b7f8\" data-element_type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-a74a7ff\" data-id=\"a74a7ff\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-fdb095d elementor-widget elementor-widget-heading\" data-id=\"fdb095d\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">MDRF\/GHTF Guides\n<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-e86ef16 elementor-tabs-view-vertical tabs-custom elementor-widget elementor-widget-tabs\" data-id=\"e86ef16\" data-element_type=\"widget\" data-widget_type=\"tabs.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-tabs\">\n\t\t\t<div class=\"elementor-tabs-wrapper\" role=\"tablist\" >\n\t\t\t\t\t\t\t\t\t<div id=\"elementor-tab-title-2431\" class=\"elementor-tab-title elementor-tab-desktop-title\" aria-selected=\"true\" data-tab=\"1\" role=\"tab\" tabindex=\"0\" aria-controls=\"elementor-tab-content-2431\" aria-expanded=\"false\">IMDRF\/AE WG\/N43<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t\t<div class=\"elementor-tabs-content-wrapper\" role=\"tablist\" aria-orientation=\"vertical\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-tab-title elementor-tab-mobile-title\" aria-selected=\"true\" data-tab=\"1\" role=\"tab\" tabindex=\"0\" aria-controls=\"elementor-tab-content-2431\" aria-expanded=\"false\">IMDRF\/AE WG\/N43<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-2431\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"1\" role=\"tabpanel\" aria-labelledby=\"elementor-tab-title-2431\" tabindex=\"0\" hidden=\"false\"><p><span style=\"color: #023e7d; font-weight: bold;\">Date :<\/span> 2020<\/p><p><span style=\"color: #023e7d; font-weight: bold;\">Author :<\/span> IMDRF<\/p><p><span style=\"color: #023e7d; font-weight: bold;\">Goal\/scope :<\/span><\/p><p>Terminologies for categorized Adverse Event Reporting (AER): terms, terminology and codes<\/p><p>This document is available at the following address:<\/p><p><a href=\"https:\/\/www.imdrf.org\/documents\/terminologies-categorized-adverse-event-reporting-aer-terms-terminology-and-codes\">https:\/\/www.imdrf.org\/documents\/terminologies-categorized-adverse-event-reporting-aer-terms-terminology-and-codes<\/a><\/p><p>We are at your disposal to help you understand and apply these recommendations &#8211; do not hesitate to contact us: <a href=\"mailto:contact@ceiso.fr\">contact@ceiso.fr<\/a><\/p><\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>ICH Guidelines for Good Clinical Practices E6 (R2) GCP (BCP) GCP (BCP) Date : 15\/12\/2016 (Final adoption by the CHMP) &#8211; June 14, 2017 (Effective date) Author : ICH Goal\/scope : Internationally recognized recommendations for good clinical practices in biomedical research. https:\/\/www.ema.europa.eu\/en\/ich-e6-r2-good-clinical-practice-scientific-guideline We are at your disposal to assist you in understanding and implementing these [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":[],"_links":{"self":[{"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/pages\/227"}],"collection":[{"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/comments?post=227"}],"version-history":[{"count":7,"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/pages\/227\/revisions"}],"predecessor-version":[{"id":236,"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/pages\/227\/revisions\/236"}],"wp:attachment":[{"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/media?parent=227"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}