{"id":4021,"date":"2023-05-25T10:35:45","date_gmt":"2023-05-25T08:35:45","guid":{"rendered":"https:\/\/www.pharmaeducationcenter.it\/uncategorized\/the-pharmacovigilance-system-and-its-local-applications\/"},"modified":"2026-04-17T14:40:25","modified_gmt":"2026-04-17T12:40:25","slug":"the-pharmacovigilance-system-and-its-local-applications","status":"publish","type":"product","link":"https:\/\/www.pharmaeducationcenter.it\/en\/trainings\/pharmacovigilance\/the-pharmacovigilance-system-and-its-local-applications\/","title":{"rendered":"The Pharmacovigilance system and its local applications according to legislation and Eudravigilance"},"content":{"rendered":"<p>The pharmacovigilance system has evolved over time, starting from the benefit\/risk assessment of a drug performed on the analysis of individual cases arriving at the development of periodic safety reports and finally finding its full expression in Good Pharmacovigilance Practices (GVPs). The application of the principles of GVPs, with the management of risk and quality plans, has made pharmacovigilance a major function in the Pharmaceutical Company today. With a view to continuous improvement of the appropriateness of use of a given pharmaceutical treatment towards the patient, the Pharmacovigilance specialist must play this delicate role to the best of his or her ability and must develop an all-round technical and practical expertise on GVPs. Moreover, the digital transformation typical of the modern era is radically changing both the business approach of pharmacovigilance practitioners and the characteristics of the pharmacovigilance professional figure that will be sought after in the near future.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The pharmacovigilance system has evolved over time, starting from the benefit\/risk assessment of a drug performed on the analysis of individual cases arriving at the development of periodic safety reports and finally finding its full expression in Good Pharmacovigilance Practices (GVPs).<\/p>\n","protected":false},"featured_media":4018,"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":{"0":"post-4021","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-pharmacovigilance","7":"product_cat-corsi-di-formazione","8":"product_cat-farmacovigilanza","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":"sale","21":"taxable","22":"shipping-taxable","23":"purchasable","24":"product-type-variable"},"acf":{"corso_new_label":false,"corso_promo_label":false,"corso_pdf_programma":"","corso_programma":"09:30 \u2013 13:00 DAY 1\r\n09:30 - 13:00 DAY 2\r\n\r\nSESSION DAY 1\r\n<ul>\r\n \t<li>Pharmacovigilance: overview, historical background, evolution and objectives<\/li>\r\n \t<li>Pharmacovigilance legislation in Europe and Italy<\/li>\r\n \t<li>Role of national and international regulatory agencies (AIFA, EMA)<\/li>\r\n \t<li>Role of the AIC Holder<\/li>\r\n \t<li>Interactions of pharmacovigilance with other business functions<\/li>\r\n \t<li>Pharmacovigilance interactions with third parties<\/li>\r\n \t<li>Pharmacovigilance in clinical research: interventional, observational, nonprofit studies<\/li>\r\n \t<li>Post-marketing pharmacovigilance: sources and individual case management<\/li>\r\n \t<li>Module VI: the management of spontaneous\/solicited reports<\/li>\r\n \t<li>Pharmacovigilance management in market research, PSP, digital media<\/li>\r\n \t<li>Management of si special reports: compassionate use, Act 648, off-label<\/li>\r\n \t<li>Eudravigilance<\/li>\r\n<\/ul>\r\nSESSION DAY 2\r\n<ul>\r\n \t<li>New standards in Pharmacovigilance: the quality system<\/li>\r\n \t<li>Quality Management System in individual PV processes (Audits, Inspections, SOPs, documentation management, Training)<\/li>\r\n \t<li>Hints on pharmacovigilance and privacy<\/li>\r\n \t<li>Digital transformation and impacts on pharmacovigilance<\/li>\r\n<\/ul>","corso_target":"Specialists who work or who are interested in working in Italian pharmaceutical companies in the field of pharmacovigilance (affiliate or parent company), who want to deepen the issues of quality and good practice of pharmacovigilance, with an eye to the future linked to digital transformation.","corso_competenze":[{"corso_competenze_item":"Better manage adverse event reporting requirements in accordance with GVPs and Eudravigliance"},{"corso_competenze_item":"Better manage interactions with other departments and Third Parties"},{"corso_competenze_item":"Better manage the local pharmacovigilance system, to the parent system and to local and European Regulatory Agencies"},{"corso_competenze_item":"Better manage the quality system"},{"corso_competenze_item":"Explore new opportunities in pharmacovigilance as a result of digital transformation"}]},"_links":{"self":[{"href":"https:\/\/www.pharmaeducationcenter.it\/en\/wp-json\/wp\/v2\/product\/4021","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\/4018"}],"wp:attachment":[{"href":"https:\/\/www.pharmaeducationcenter.it\/en\/wp-json\/wp\/v2\/media?parent=4021"}],"wp:term":[{"taxonomy":"product_brand","embeddable":true,"href":"https:\/\/www.pharmaeducationcenter.it\/en\/wp-json\/wp\/v2\/product_brand?post=4021"},{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/www.pharmaeducationcenter.it\/en\/wp-json\/wp\/v2\/product_cat?post=4021"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/www.pharmaeducationcenter.it\/en\/wp-json\/wp\/v2\/product_tag?post=4021"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}