{"id":3839,"date":"2023-05-11T11:50:20","date_gmt":"2023-05-11T09:50:20","guid":{"rendered":"https:\/\/www.pharmaeducationcenter.it\/uncategorized\/research-analysis-literature-pharmacovigilance\/"},"modified":"2026-07-01T09:55:07","modified_gmt":"2026-07-01T07:55:07","slug":"research-analysis-literature-pharmacovigilance","status":"publish","type":"product","link":"https:\/\/www.pharmaeducationcenter.it\/en\/trainings\/pharmacovigilance\/research-analysis-literature-pharmacovigilance\/","title":{"rendered":"Pharmacovigilance peer-reviewed literature: strategies for an effective research and analysis"},"content":{"rendered":"<p>Medical and scientific literature is a valuable source of information on medicinal products. Marketing authorization holders (MAHs) are required to monitor the literature to identify suspected adverse drug reactions (ADRs) and other important safety and efficacy information, including class effects, off-label use, misuse, and potential drug interactions. Within the European Union, it is required that, when submitting an application for a marketing authorization, the holder conducts literature searches to identify any emerging safety information.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Medical and scientific literature is a valuable source of information on medicinal products. Marketing authorization holders (MAHs) are required to monitor the literature to identify suspected adverse drug reactions (ADRs) and other important safety and efficacy information, including class effects, off-label use, misuse, and potential drug interactions.<\/p>\n","protected":false},"featured_media":11630,"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-3839","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":"<strong>PROGRAM<\/strong>\r\n\r\n09:30 \u2013 12:30 COURSE SESSION\r\n<ul>\r\n \t<li>EU regulatory references for screening of scientific medical literature in pharmacovigilance activities;<\/li>\r\n \t<li>Presentation of the various available literature sources (International databases, journals, ...) and definition of selection criteria to identify relevant articles that contain valid and invalid ICSRs, and any other new safety and efficacy information on medicinal products;<\/li>\r\n \t<li>MedDRA Terminology;<\/li>\r\n \t<li>EMA's Medical Literature Monitoring (MLM) service: what is the purpose and scope; tools available to the AIC holder;<\/li>\r\n \t<li>Some suggestions on how to integrate the description of the letter analysis screening process into corporate SOP\/WIs;<\/li>\r\n \t<li>What to consider when delegating literature screening activities to a third party;<\/li>\r\n \t<li>Aspects to keep in mind when implementing local non-indexed literature screening;<\/li>\r\n \t<li>Characteristics of literature searches and integration of their analysis into documents such as Periodic Safety Update Report (PSUR), Development Safety Update Report (DSUR), Risk Management Plan (RMP), and signal analysis activities.<\/li>\r\n<\/ul>","corso_target":"The course was designed for personnel involved in the following areas:\r\n\r\n&gt; Pharmacovigilance\r\n\r\n&gt; Regulatory Affairs\r\n\r\n&gt; Medical-scientific\r\n\r\nThe course provides the general theoretical basis for undertaking literature screening and analysis. However, the course is focused on activities of relevance to pharmacovigilance.","corso_competenze":[{"corso_competenze_item":"EU regulatory requirements for screening medical scientific literature"},{"corso_competenze_item":"Literature sources and selection criteria for relevant articles to identify valid ICSRs and any other new drug safety information"},{"corso_competenze_item":"EMA's Medical Literature Monitoring (MLM) service"},{"corso_competenze_item":"Literature analysis within PSURs\/DSURs\/RMPs and in signal analysis activities"},{"corso_competenze_item":"Activities related to literature screening and analysis: description in corporate SOP\/WI and delegation to third parties (including screening of local non-indexed literature)"}]},"_links":{"self":[{"href":"https:\/\/www.pharmaeducationcenter.it\/en\/wp-json\/wp\/v2\/product\/3839","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\/11630"}],"wp:attachment":[{"href":"https:\/\/www.pharmaeducationcenter.it\/en\/wp-json\/wp\/v2\/media?parent=3839"}],"wp:term":[{"taxonomy":"product_brand","embeddable":true,"href":"https:\/\/www.pharmaeducationcenter.it\/en\/wp-json\/wp\/v2\/product_brand?post=3839"},{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/www.pharmaeducationcenter.it\/en\/wp-json\/wp\/v2\/product_cat?post=3839"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/www.pharmaeducationcenter.it\/en\/wp-json\/wp\/v2\/product_tag?post=3839"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}