{"id":5378,"date":"2023-06-21T11:55:03","date_gmt":"2023-06-21T09:55:03","guid":{"rendered":"https:\/\/www.pharmaeducationcenter.it\/?post_type=product&p=5378"},"modified":"2026-01-14T10:36:55","modified_gmt":"2026-01-14T09:36:55","slug":"ctd-module-3-critical-aspects","status":"publish","type":"product","link":"https:\/\/www.pharmaeducationcenter.it\/en\/trainings\/regulatory-affairs\/ctd-module-3-critical-aspects\/","title":{"rendered":"Common Technical Document (CTD) module 3: focus on the most critical aspects"},"content":{"rendered":"

Pharma Education Center organizes the training course \u201cCommon Technical Document (CTD) module 3: focus on the most critical aspects\u201d a day of in-depth study on the key points of the CTD Module 3 of synthetic drugs for human use. The main technical-regulatory issues encountered during the preparation and approval of the drug quality dossier will be examined and discussed, also in the light of the experience gained at the Italian drug agency (AIFA), and useful information and suggestions will be passed on to delegates, to help them consolidate a dossier effectively.<\/p>\n","protected":false},"excerpt":{"rendered":"

Pharma Education Center organizes the training course \u201cCommon Technical Document (CTD) module 3: focus on the most critical aspects\u201d a day of in-depth study on the key points of the CTD Module 3 of synthetic drugs for human use.<\/p>\n","protected":false},"featured_media":5386,"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 center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"_joinchat":[]},"product_brand":[],"product_cat":[106,98,117,118],"product_tag":[],"class_list":{"0":"post-5378","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-regulatory-affairs","7":"product_cat-affari-regolatori","8":"product_cat-corsi-di-formazione","9":"product_cat-trainings","10":"desktop-align-left","11":"tablet-align-left","12":"mobile-align-left","13":"ast-product-gallery-layout-horizontal-slider","14":"ast-product-gallery-with-no-image","15":"ast-magnify-disabled","16":"ast-product-single-variable","18":"first","19":"instock","20":"taxable","21":"shipping-taxable","22":"purchasable","23":"product-type-variable"},"acf":{"corso_new_label":false,"corso_promo_label":false,"corso_pdf_programma":"","corso_programma":"09:30 \u2013 12:30 MORNING SESSION\r\n14:00 \u2013 17:00 AFTERNOON SESSION\r\n

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  • Critical Steps, Intermediate, Bulk<\/li>\r\n \t
  • Process validation: review of EMA guideline<\/li>\r\n \t
  • Standard vs non-standard process definition: reference legislation<\/li>\r\n \t
  • Sterilization of actives, finished products, containers: reference legislation<\/li>\r\n<\/ul>\r\nStability\r\n
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    • Definitions of shelf-life and re-test period<\/li>\r\n \t
    • How to define specifications<\/li>\r\n \t
    • Formal stability, in-use, thermal cycling, stress study<\/li>\r\n \t
    • Other guidelines (e.g., stability to support variations)<\/li>\r\n<\/ul>\r\nImpurities\r\n
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      • ICHQ3A<\/li>\r\n \t
      • ICHQ3B<\/li>\r\n \t
      • ICHQ3C and EMA guideline residual solvents<\/li>\r\n \t
      • Hints at ICHQ3D and ICHM7<\/li>\r\n<\/ul>\r\n<\/div>\r\n<\/div>\r\n<\/div>\r\n<\/div>\r\n<\/div>\r\n<\/div>\r\n<\/div>\r\n<\/div>\r\n<\/div>\r\n<\/div>\r\n<\/div>\r\n<\/div>\r\n<\/div>","corso_target":"
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        \r\n\r\nProfessionals involved in the pharmaceutical sector: Regulatory Affairs, Development Documentation, QA & Regulatory Compliance, Research and Development.\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":"Regulatory aspects"},{"corso_competenze_item":"Major shortcomings found in the review and approval of dossiers of chemically synthesized drugs for human use"},{"corso_competenze_item":"Module 3 drafting: discussion of some critical points (Active Substance and Finished Drug)"}]},"_links":{"self":[{"href":"https:\/\/www.pharmaeducationcenter.it\/en\/wp-json\/wp\/v2\/product\/5378","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\/5386"}],"wp:attachment":[{"href":"https:\/\/www.pharmaeducationcenter.it\/en\/wp-json\/wp\/v2\/media?parent=5378"}],"wp:term":[{"taxonomy":"product_brand","embeddable":true,"href":"https:\/\/www.pharmaeducationcenter.it\/en\/wp-json\/wp\/v2\/product_brand?post=5378"},{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/www.pharmaeducationcenter.it\/en\/wp-json\/wp\/v2\/product_cat?post=5378"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/www.pharmaeducationcenter.it\/en\/wp-json\/wp\/v2\/product_tag?post=5378"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}