{"id":17123,"date":"2025-08-22T17:05:43","date_gmt":"2025-08-22T15:05:43","guid":{"rendered":"https:\/\/www.pharmaeducationcenter.it\/?post_type=product&p=17123"},"modified":"2026-03-04T15:14:08","modified_gmt":"2026-03-04T14:14:08","slug":"eu-variations-regulatory-lifecycle-management","status":"publish","type":"product","link":"https:\/\/www.pharmaeducationcenter.it\/en\/trainings\/regulatory-affairs\/eu-variations-regulatory-lifecycle-management\/","title":{"rendered":"EU Variations and Regulatory Lifecycle Management"},"content":{"rendered":"

This training course provides a comprehensive overview of all maintenance activities throughout the lifecycle of a medicinal product, delving into the specifics of EU variation regulations and guidelines.<\/p>\n

The programme provides detailed knowledge of the classification, grouping and submission of variations in the EU, covering both procedural and contextual topics.<\/p>\n

Upon completion, you will have learned everything you need to know about the key principles of variation submission and variation procedures, including Commission Delegated Regulation (EU) 2024\/1701, as well as gaining an overview of other post-authorisation procedures.<\/p>\n

 <\/p>\n

The training is organised in collaboration with Zwiers Regulatory Consultancy \u2013 A ProductLife Group Company.<\/strong><\/p>\n","protected":false},"excerpt":{"rendered":"

This training course provides a comprehensive overview of all maintenance activities throughout the lifecycle of a medicinal product, delving into the specifics of EU variation regulations and guidelines.<\/p>\n","protected":false},"featured_media":14430,"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-17123","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":true,"corso_promo_label":false,"corso_pdf_programma":"","corso_programma":"

Training structure<\/strong><\/h5>\r\n9.00 am - 1.0 pm MORNING SESSION\r\n
Program<\/h5>\r\n09:00\u00a0 Welcome, introduction and technical check<\/strong>\r\n\r\n09:15 \u2013 10:45\u00a0 Variations procedures \u2013 Part I<\/strong>\r\n
    \r\n \t
  • Background<\/li>\r\n \t
  • Category of variations and decision tree<\/li>\r\n \t
  • Recommendation on unforeseen variations (Article 5)<\/li>\r\n \t
  • Types of variations (Type IA \/ IAIN<\/sub>, Type IB, Type II)<\/li>\r\n \t
  • Procedural issues and timelines<\/li>\r\n<\/ul>\r\n10:45\u00a0 Coffee break<\/strong>\r\n\r\n11:00 \u2013 11:50\u00a0 Variations procedures \u2013 Part II<\/strong>\r\n
      \r\n \t
    • Grouping and work sharing<\/li>\r\n \t
    • Application Form, Cover Letter etc.<\/li>\r\n<\/ul>\r\n11:50 \u2013 13:00\u00a0 Other post-approval activities<\/strong>\r\n
        \r\n \t
      • Line Extension<\/li>\r\n \t
      • Renewals and referrals:<\/li>\r\n \t
      • Other procedures following approval: Articles 45 and 46 of the Paediatric Regulation, transfer of marketing authorisation, post-authorisation measures, procedures for repeated use and change of RMS<\/li>\r\n \t
      • Pharmacovigilance duties<\/li>\r\n<\/ul>\r\n13:00\u00a0 End of seminar<\/strong>","corso_target":"This online-learning course is intended for anyone working on EU variations, classifying or submitting them to the relevant agency, particularly those involved in regulatory affairs.","corso_competenze":[{"corso_competenze_item":"Variations system and procedures"},{"corso_competenze_item":"Post-approval activities and procedures, other than variations"},{"corso_competenze_item":"Safety-related obligations and labelling"},{"corso_competenze_item":"EU Application Form and Cover Letter"}]},"_links":{"self":[{"href":"https:\/\/www.pharmaeducationcenter.it\/en\/wp-json\/wp\/v2\/product\/17123","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\/14430"}],"wp:attachment":[{"href":"https:\/\/www.pharmaeducationcenter.it\/en\/wp-json\/wp\/v2\/media?parent=17123"}],"wp:term":[{"taxonomy":"product_brand","embeddable":true,"href":"https:\/\/www.pharmaeducationcenter.it\/en\/wp-json\/wp\/v2\/product_brand?post=17123"},{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/www.pharmaeducationcenter.it\/en\/wp-json\/wp\/v2\/product_cat?post=17123"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/www.pharmaeducationcenter.it\/en\/wp-json\/wp\/v2\/product_tag?post=17123"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}