{"id":6232,"date":"2023-07-18T16:40:05","date_gmt":"2023-07-18T14:40:05","guid":{"rendered":"https:\/\/www.pharmaeducationcenter.it\/?post_type=product&#038;p=6232"},"modified":"2026-07-08T16:33:39","modified_gmt":"2026-07-08T14:33:39","slug":"module-5-ctd","status":"publish","type":"product","link":"https:\/\/www.pharmaeducationcenter.it\/en\/trainings\/regulatory-affairs\/module-5-ctd\/","title":{"rendered":"Focus on the Module 5 of the Common Technical Document (CTD)"},"content":{"rendered":"<p>The training &#8220;Focus on the Module 5 of the Common Technical Document (CTD)&#8221; starts with an overview of the legal bases for registration procedures in Europe, with a particular focus on how they affect the structure and content of the CTD. Regulatory requirements, as well as the correlations between toxicology studies, subsequent clinical development, and the registration dossier, in terms of expectations of the European Health Authorities, will be explained. \u00a0The training will also provide an overview on the clinical development phases of a medicinal product, including post-authorization studies. A focus on the pediatric regulation 1902\/2006 requirements will follow, with the aim to illustrate how these requirements can change depending on the legal basis of the registration dossier. Finally, discussion on the guideline on bioequivalence studies will close the training.<\/p>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The training &#8220;Focus on the Module 5 of the Common Technical Document (CTD)&#8221; starts with an overview of the legal bases for registration procedures in Europe, with a particular focus on how they affect the structure and content of the CTD.<\/p>\n","protected":false},"featured_media":6248,"template":"","meta":{"_acf_changed":false,"site-sidebar-layout":"default","site-content-layout":"default","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"default","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center 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registration dossier\r\n\r\nThe clinical development:\r\n<ul>\r\n \t<li>Phases of clinical development<\/li>\r\n \t<li>Pediatric regulation 1902\/2006<\/li>\r\n \t<li>Post-authorization clinical studies<\/li>\r\n \t<li>Bioequivalence study CPMP\/QWP\/EWP\/1401\/98 Rev. 1 Corr (January 2010)<\/li>\r\n \t<li>Q&amp;A Session<\/li>\r\n<\/ul>","corso_target":"<div class=\"et_pb_section et_pb_section_4 et_section_regular\">\r\n<div class=\"et_pb_row et_pb_row_2\">\r\n<div class=\"et_pb_column et_pb_column_4_4 et_pb_column_4 et_pb_css_mix_blend_mode_passthrough et-last-child\">\r\n<div class=\"et_pb_module et_pb_tabs et_pb_tabs_0 et_slide_transition_to_1\">\r\n<div class=\"et_pb_all_tabs\">\r\n<div class=\"et_pb_tab et_pb_tab_1 clearfix et-pb-active-slide\">\r\n<div class=\"et_pb_tab_content\">\r\n\r\nPersonnel involved in the pharmaceutical sector: Regulatory Affairs, Clinical Development, Scientific officer.\r\n\r\n<\/div>\r\n<\/div>\r\n<\/div>\r\n<\/div>\r\n<\/div>\r\n<\/div>\r\n<\/div>","corso_competenze":[{"corso_competenze_item":"Learn the legal bases of registrations at a European Level"},{"corso_competenze_item":"Understand how the legal basis affects the content of the registration dossier"},{"corso_competenze_item":"Get an overview of all the phases of clinical development, post-authorization clinical studies included"},{"corso_competenze_item":"Understand the requirements of the pediatric regulation 1902\/2006"},{"corso_competenze_item":"Learn about the guidelines for the conduction of bioequivalence studies and which are the fundamental requirements for health authorities"}]},"_links":{"self":[{"href":"https:\/\/www.pharmaeducationcenter.it\/en\/wp-json\/wp\/v2\/product\/6232","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.pharmaeducationcenter.it\/en\/wp-json\/wp\/v2\/product"}],"about":[{"href":"https:\/\/www.pharmaeducationcenter.it\/en\/wp-json\/wp\/v2\/types\/product"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.pharmaeducationcenter.it\/en\/wp-json\/wp\/v2\/media\/6248"}],"wp:attachment":[{"href":"https:\/\/www.pharmaeducationcenter.it\/en\/wp-json\/wp\/v2\/media?parent=6232"}],"wp:term":[{"taxonomy":"product_brand","embeddable":true,"href":"https:\/\/www.pharmaeducationcenter.it\/en\/wp-json\/wp\/v2\/product_brand?post=6232"},{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/www.pharmaeducationcenter.it\/en\/wp-json\/wp\/v2\/product_cat?post=6232"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/www.pharmaeducationcenter.it\/en\/wp-json\/wp\/v2\/product_tag?post=6232"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}