{"id":4068,"date":"2023-05-22T09:55:34","date_gmt":"2023-05-22T07:55:34","guid":{"rendered":"https:\/\/www.pharmaeducationcenter.it\/uncategorized\/pharmacovigilance-clinical-trials\/"},"modified":"2026-07-01T10:54:35","modified_gmt":"2026-07-01T08:54:35","slug":"pharmacovigilance-clinical-trials","status":"publish","type":"product","link":"https:\/\/www.pharmaeducationcenter.it\/en\/trainings\/clinical-research\/pharmacovigilance-clinical-trials\/","title":{"rendered":"Pharmacovigilance in Clinical Trials"},"content":{"rendered":"<p>One of the main priorities of a clinical trial is the safety of the subjects enrolled in it. For this reason, pharmacovigilance in clinical trials is one of the most important aspects to consider for proper risk assessment of the experimental drug. Therefore, it should always be evolving and adapted to regional and local regulations. The introduction of Regulation (EU) No. 536\/2014 of the European Parliament is a new challenge to be faced but at the same time an opportunity for an area, such as Europe, hitherto fragmented by various local regulations. For the purpose of assessing the benefit-risk ratio, the Development Safety Update Report (DSUR) is a mandatory annual report to be submitted to the Competent Authority and aimed at informing about the progress of the clinical trial and the safety risk analysis of the investigational drug under study, comparing also with worldwide experience, so as to ensure proper protection for enrolled subjects.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>One of the main priorities of a clinical trial is the safety of the subjects enrolled in it. For this reason, pharmacovigilance in clinical trials is one of the most important aspects to consider for proper risk assessment of the experimental drug.<\/p>\n","protected":false},"featured_media":3765,"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":[102,117,115,116,94,118],"product_tag":[],"class_list":["post-4068","product","type-product","status-publish","has-post-thumbnail","product_cat-clinical-research","product_cat-corsi-di-formazione","product_cat-farmacovigilanza","product_cat-pharmacovigilance","product_cat-ricerca-clinica","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":"09:30 \u2013 12:30 MORNING SESSION\r\n14:00 \u2013 17:00 AFTERNOON SESSION\r\n<ul>\r\n \t<li>Normative requirements<\/li>\r\n \t<li>Types of clinical trials<\/li>\r\n \t<li>Figures involved and responsibilities<\/li>\r\n \t<li>Management of reports from clinical trials<\/li>\r\n \t<li>Safety Management Plan<\/li>\r\n \t<li>Development Safety Update Report<\/li>\r\n<\/ul>","corso_target":"Personnel involved in the areas of Pharmacovigilance, Clinical, Regulatory Affairs. 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