{"id":6127,"date":"2023-05-12T11:05:05","date_gmt":"2023-05-12T09:05:05","guid":{"rendered":"https:\/\/www.pharmaeducationcenter.it\/uncategorized\/periodic-safety-update-report\/"},"modified":"2026-06-05T16:03:39","modified_gmt":"2026-06-05T14:03:39","slug":"periodic-safety-update-report","status":"publish","type":"product","link":"https:\/\/www.pharmaeducationcenter.it\/en\/trainings\/pharmacovigilance\/periodic-safety-update-report\/","title":{"rendered":"Periodic Safety Update Report (PSUR)"},"content":{"rendered":"<p>Periodic Safety Update Reports, also called PSURs, are pharmacovigilance documents aimed at providing an assessment of the risk-benefit balance of a medicinal product. They are to be submitted by a marketing authorization holder at predefined deadlines during the post-authorization phase, including a comprehensive, concise and critical analysis of the risk-benefit balance of a medicinal product, taking into account all new or emerging information, in relation to the context of the overall information available on the drug.<\/p>\n<p>Directive 2010\/84\/EU introduced the principle of single European assessment of PSURs (PSUSA procedure), for medicinal products containing the same active substances or combinations thereof and established the creation of a single list of active substances and associated Data Lock Points (EURD list). Compliance with the recommendations and conclusions of the PSUSA procedures is a legal obligation for AIC holders, also including medicinal products exempted from participation in the procedure but containing the same active ingredients.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Periodic Safety Update Reports, also called PSURs, are pharmacovigilance documents aimed at providing an assessment of the risk-benefit balance of a medicinal product.<\/p>\n","protected":false},"featured_media":3185,"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":[116,117,115,118],"product_tag":[],"class_list":["post-6127","product","type-product","status-publish","has-post-thumbnail","product_cat-pharmacovigilance","product_cat-corsi-di-formazione","product_cat-farmacovigilanza","product_cat-trainings","desktop-align-left","tablet-align-left","mobile-align-left","ast-product-gallery-layout-horizontal-slider","ast-product-gallery-with-no-image","ast-magnify-disabled","ast-product-single-variable","first","instock","sale","taxable","shipping-taxable","purchasable","product-type-variable"],"acf":{"corso_new_label":false,"corso_promo_label":false,"corso_pdf_programma":"","corso_programma":"09:00 \u2013 13:00 COURSE SESSION\r\n<ul>\r\n \t<li>European regulatory framework and guidelines<\/li>\r\n \t<li>PSUR submission timings and drugs exempted from PSUR submission: creation of the PSUR plan (Eurd List monitoring, consultation of other lists, ...)<\/li>\r\n \t<li>PSUR format and document contents (including information to be requested from other departments). Key concepts will be described and which relevant information should be included and discussed in the document will be clarified<\/li>\r\n \t<li>Cross references with other documents and activities (RMP, signal analysis,...)<\/li>\r\n \t<li>Submission to PSUR repository (general description of steps)<\/li>\r\n \t<li>PSUSA procedure: what it is, which steps, examples of assessment reports and requests from the assessor, output of the procedure and regulatory consequences<\/li>\r\n \t<li>PSUSA Procedure FU<\/li>\r\n<\/ul>","corso_target":"Personnel of pharmaceutical companies involved in the following departments:\r\n\r\n&gt; Pharmacovigilance\r\n&gt; Regulatory Affairs\r\n&gt; Medical-scientific\r\n\r\nThe course provides the theoretical foundations necessary to undertake the drafting of a PSUR and provides indications regarding the management and planning of the PSURs to be submitted.","corso_competenze":[{"corso_competenze_item":"Reference legislation for the PSUR"},{"corso_competenze_item":"How to develop the plan of PSURs (requirements and submission frequencies)"},{"corso_competenze_item":"What is the format of the PSUR and what information should be submitted and analysed?"},{"corso_competenze_item":"What interactions with other business departments may be necessary in drafting the document and its submission"},{"corso_competenze_item":"What are PSUSA and PSUSA FU procedures and what actions may result from them"}]},"_links":{"self":[{"href":"https:\/\/www.pharmaeducationcenter.it\/en\/wp-json\/wp\/v2\/product\/6127","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\/3185"}],"wp:attachment":[{"href":"https:\/\/www.pharmaeducationcenter.it\/en\/wp-json\/wp\/v2\/media?parent=6127"}],"wp:term":[{"taxonomy":"product_brand","embeddable":true,"href":"https:\/\/www.pharmaeducationcenter.it\/en\/wp-json\/wp\/v2\/product_brand?post=6127"},{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/www.pharmaeducationcenter.it\/en\/wp-json\/wp\/v2\/product_cat?post=6127"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/www.pharmaeducationcenter.it\/en\/wp-json\/wp\/v2\/product_tag?post=6127"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}