{"id":6203,"date":"2023-07-18T15:53:29","date_gmt":"2023-07-18T13:53:29","guid":{"rendered":"https:\/\/www.pharmaeducationcenter.it\/?post_type=product&p=6203"},"modified":"2025-11-24T09:34:39","modified_gmt":"2025-11-24T08:34:39","slug":"drug-device-combination-products-training","status":"publish","type":"product","link":"https:\/\/www.pharmaeducationcenter.it\/en\/trainings\/medical-device\/drug-device-combination-products-training\/","title":{"rendered":"Drug-Device combination products in EU and US"},"content":{"rendered":"

The training course \u201cDrug-device combination products in EU and US<\/em>\u201d will explore the EU and US regulatory landscape<\/strong> defining the key differences, similarities and provide an overview of the regulatory pathways<\/strong> and how to successfully navigate between drugs, devices and combination products<\/strong> in each jurisdiction.
\nThe course will also provide a detailed overview of impact of the EU medical device regulation on combination products<\/strong> and the life cycle management<\/strong> of combination products.
\nEnhancing capabilities to develop and launch successful combination products will remain a top priority; with product usability, integrating digital platforms and general management across the total product life cycle becoming critical.
\nHowever, with a regulatory landscape that is inconsistent between EU and US, remaining compliant, maintaining quality and ensuring safety requires clear, concise and consistent guidance on regulations.<\/p>\n","protected":false},"excerpt":{"rendered":"

The training course \u201cDrug-device combination products in EU and US\u201d will explore the EU and US regulatory landscape defining the key differences, similarities and provide an overview of the regulatory pathways and how to successfully navigate between drugs, devices and combination products in each jurisdiction.<\/p>\n","protected":false},"featured_media":6219,"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":[105,98,117,96,106,118],"product_tag":[],"class_list":{"0":"post-6203","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-medical-device","7":"product_cat-affari-regolatori","8":"product_cat-corsi-di-formazione","9":"product_cat-dispositivi-medici","10":"product_cat-regulatory-affairs","11":"product_cat-trainings","12":"desktop-align-left","13":"tablet-align-left","14":"mobile-align-left","15":"ast-product-gallery-layout-horizontal-slider","16":"ast-product-gallery-with-no-image","17":"ast-magnify-disabled","18":"ast-product-single-variable","20":"first","21":"instock","22":"taxable","23":"shipping-taxable","24":"purchasable","25":"product-type-variable"},"acf":{"corso_new_label":false,"corso_promo_label":false,"corso_pdf_programma":"","corso_programma":"

Struttura del corso<\/h5>\r\n09:00\u2013 13:00 COURSE SESSION DAY 1\r\n09:00\u2013 13:00 COURSE SESSION DAY 2\r\n
Programma<\/h5>\r\n

Day 1<\/em><\/h3>\r\nIntroduction & speed networking<\/strong>\r\n\r\nCombination Products in EU<\/strong>\r\n
    \r\n \t
  • Definitions in EU\r\n
      \r\n \t
    • Combination Product<\/li>\r\n \t
    • Medicinal Product<\/li>\r\n \t
    • Medical Device<\/li>\r\n<\/ul>\r\n<\/li>\r\n \t
    • Legal framework\r\n
        \r\n \t
      • Medicinal product and medical device legislations<\/li>\r\n \t
      • Revision to EU Medical Device Regulation (MDR)<\/li>\r\n \t
      • Regulatory similarities and differences<\/li>\r\n<\/ul>\r\n<\/li>\r\n \t
      • Borderline classification in EU: Medical Device or Medicinal product?\r\n
          \r\n \t
        • The importance of classification & its implication<\/li>\r\n \t
        • Decision Making on the Borderline<\/li>\r\n<\/ul>\r\n<\/li>\r\n<\/ul>\r\nQ&A time<\/strong>\r\n\r\nEU Market access for Drug Device Combination Products (DDCs)<\/strong>\r\n
            \r\n \t
          • Single integral non-reusable DDCs<\/li>\r\n \t
          • Non-integral Combination Products (kit)<\/li>\r\n \t
          • Data requirements<\/li>\r\n \t
          • Labelling requirements<\/li>\r\n \t
          • Guidance documents<\/li>\r\n<\/ul>\r\nQ&A time<\/strong>\r\n\r\nBreak<\/strong>\r\n\r\nCombination Products in US<\/strong>\r\n
              \r\n \t
            • Combination Product Definition<\/li>\r\n \t
            • History and Legal Framework<\/li>\r\n \t
            • Borderline Products<\/li>\r\n \t
            • Types of Combination Product (Definitions)<\/li>\r\n \t
            • Primary Mode of Action and FDA\u2019s Assignment Algorithm<\/li>\r\n \t
            • Jurisdiction and Designation Process for Combination Products<\/li>\r\n<\/ul>\r\nQ&A time<\/strong>\r\n\r\nClosure of day one<\/strong>\r\n

              <\/h3>\r\n

              DAY 2<\/em><\/h3>\r\nEU market access for Device Drug Combination Products<\/strong>\r\n
                \r\n \t
              • EU MDR Classification and applicable rule(s)<\/li>\r\n \t
              • Notified Body\u2019s role and obligations<\/li>\r\n \t
              • What is CE Marking?<\/li>\r\n \t
              • CE certification process at a glance<\/li>\r\n \t
              • Documentation requirements at top level<\/li>\r\n<\/ul>\r\nQ&A time<\/strong>\r\n\r\n\u00a0<\/strong>EU MDR key changes and its Impact on Drug Device Combination Products\u00a0<\/strong>\r\n
                  \r\n \t
                • Impact on combination products regulated as medicinal product<\/li>\r\n \t
                • Article 117 and Notified Body Opinion report (NBOp)<\/li>\r\n \t
                • Notified Body selection and Interaction<\/li>\r\n \t
                • Documentation requirements<\/li>\r\n \t
                • Life Cycle management: New or updated NBOp?\r\n
                    \r\n \t
                  • Team-NB position<\/li>\r\n \t
                  • Industry perspective<\/li>\r\n<\/ul>\r\n<\/li>\r\n<\/ul>\r\nQ&A time<\/strong>\r\n\r\nBreak<\/strong>\r\n\r\nUS market access for Combination Products<\/strong>\r\n
                      \r\n \t
                    • FDA\u2019s approach to Combination Products<\/li>\r\n \t
                    • Submissions and Regulatory Pathways<\/li>\r\n \t
                    • Current Good Manufacturing Practice (cGMP) Requirements<\/li>\r\n \t
                    • Strategies for Development of Combination Products<\/li>\r\n<\/ul>\r\nQ&A time<\/strong>\r\n\r\nConclusion<\/strong>\u00a0<\/strong>\r\n\r\nFinal Questions session<\/strong>","corso_target":"
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                      \r\n\r\nThis Training Course is of particular interest to professionals working in:\r\n
                        \r\n \t
                      • Quality Assurance<\/li>\r\n \t
                      • Quality Control<\/li>\r\n \t
                      • Regulatory Affairs<\/li>\r\n \t
                      • Design and development of Combination Products<\/li>\r\n \t
                      • Suppling medical devices to the pharma\/biotech industry<\/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>\r\n<\/div>","corso_competenze":[{"corso_competenze_item":"Understand how combination products are defined and classified in EU and US"},{"corso_competenze_item":"Learn how borderline products are classified in EU and US"},{"corso_competenze_item":"Understand the regulatory pathways and how to successfully navigate between drugs, devices and combination products in each jurisdiction"},{"corso_competenze_item":"Learn about the EU Medical Device Regulation impact on Combination Products"},{"corso_competenze_item":"Gain a deeper understanding of the roles of EU Competent Authorities and Notified Bodies"}]},"_links":{"self":[{"href":"https:\/\/www.pharmaeducationcenter.it\/en\/wp-json\/wp\/v2\/product\/6203","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\/6219"}],"wp:attachment":[{"href":"https:\/\/www.pharmaeducationcenter.it\/en\/wp-json\/wp\/v2\/media?parent=6203"}],"wp:term":[{"taxonomy":"product_brand","embeddable":true,"href":"https:\/\/www.pharmaeducationcenter.it\/en\/wp-json\/wp\/v2\/product_brand?post=6203"},{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/www.pharmaeducationcenter.it\/en\/wp-json\/wp\/v2\/product_cat?post=6203"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/www.pharmaeducationcenter.it\/en\/wp-json\/wp\/v2\/product_tag?post=6203"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}