{"id":9083,"date":"2024-04-09T09:14:09","date_gmt":"2024-04-09T07:14:09","guid":{"rendered":"https:\/\/www.caber.it\/compliance\/pharmacovigilance\/"},"modified":"2026-03-19T14:02:26","modified_gmt":"2026-03-19T13:02:26","slug":"pharmacovigilance","status":"publish","type":"page","link":"https:\/\/www.caber.it\/en\/compliance\/pharmacovigilance\/","title":{"rendered":"Pharmacovigilance"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"9083\" class=\"elementor elementor-9083 elementor-78\" data-elementor-post-type=\"page\">\n\t\t\t\t<div class=\"elementor-element elementor-element-cec2251 e-flex e-con-boxed e-con e-parent\" data-id=\"cec2251\" data-element_type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-53ebbd3 e-con-full e-flex e-con e-child\" data-id=\"53ebbd3\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-b242285 elementor-widget elementor-widget-heading\" data-id=\"b242285\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Pharmacovigilance<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2e0d1d9 elementor-widget elementor-widget-breadcrumbs\" data-id=\"2e0d1d9\" data-element_type=\"widget\" data-widget_type=\"breadcrumbs.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<p id=\"breadcrumbs\"><span><span><a href=\"https:\/\/www.caber.it\/en\/\"><span class=\"icon-home\"> <img decoding=\"async\" src=\"https:\/\/www.caber.it\/wp-content\/uploads\/2024\/05\/home-alt-2.svg\"> <\/span><\/a><\/span><\/span><\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-9ff91f0 e-con-full e-flex e-con e-parent\" data-id=\"9ff91f0\" data-element_type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-58bf315 e-con-full e-flex e-con e-child\" data-id=\"58bf315\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-445465e elementor-widget elementor-widget-heading\" data-id=\"445465e\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">What is Pharmacovigilance<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-4aefe3c elementor-widget elementor-widget-text-editor\" data-id=\"4aefe3c\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Pharmacovigilance is the set of activities aimed at continuously evaluating all information relating to the safety of medicines in order to ensure that, for all medicines, there is a favorable benefit\/risk ratio for the population.<\/p>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-bd3d97e elementor-widget elementor-widget-text-editor\" data-id=\"bd3d97e\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>In line with this general definition, the main objectives of Pharmacovigilance are:<\/p>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5ba17dc elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"5ba17dc\" data-element_type=\"widget\" data-widget_type=\"icon-list.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<ul class=\"elementor-icon-list-items\">\n\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-circle\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M256 8C119 8 8 119 8 256s111 248 248 248 248-111 248-248S393 8 256 8z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Promote and protect public health by improving the use of medicines by detecting, evaluating, understanding and preventing side effects or any other problems related to the medicine.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-circle\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M256 8C119 8 8 119 8 256s111 248 248 248 248-111 248-248S393 8 256 8z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Promote the safe and effective use of medicines through timely communication of medicine safety information to healthcare professionals, patients and the public.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t<\/ul>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-9c043b2 elementor-widget elementor-widget-heading\" data-id=\"9c043b2\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">What is an adverse reaction? <\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-e416e26 elementor-widget elementor-widget-text-editor\" data-id=\"e416e26\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>An Adverse Reaction is a harmful and unintentional response following the use of a medicine.<\/p>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-55882a5 elementor-widget elementor-widget-text-editor\" data-id=\"55882a5\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Adverse Reactions may arise from authorized or unauthorized use of the medicine.<span style=\"color: var( --e-global-color-text );\"> <\/span><\/p>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-e3efe29 elementor-widget elementor-widget-text-editor\" data-id=\"e3efe29\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Particular situations such as professional exposure, exposure during pregnancy and breastfeeding, lack of efficacy, overdose, off-label use (use of the medicine for unauthorized indications), abuse, improper use and therapeutic errors, falsified medicines, elderly and pediatric population.<\/p>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-50299dd elementor-widget elementor-widget-heading\" data-id=\"50299dd\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">What to di in case of a suspected adverse reaction or side effect to medicine?<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b860420 elementor-widget elementor-widget-text-editor\" data-id=\"b860420\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Reporting suspected adverse reactions that occur after authorization of the medicinal product is important to allow continuous monitoring of its benefit\/risk balance. If you experience any adverse reactions or side effects with the use of any of our products, please contact your doctor\/pharmacist, local health authority or pharmaceutical company to report your experience. Spontaneous reporting by doctors, pharmacists, other healthcare professionals and by patients themselves is essential to allow the Authorities Healthcare departments responsible for health activities of Pharmacovigilance and the Pharmaceutical Companies themselves to define and keep updated the tolerability profile and drug safety (risk\/benefit ratio).<\/p>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-bbca5ce elementor-widget elementor-widget-text-editor\" data-id=\"bbca5ce\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Reports of suspected adverse reactions (ADR, Adverse Drug Reaction in English) from drugs and vaccines allow the detection of potential alarm signals relating to the use of medicines as to make them more safe, for the benefit of all patients.<\/p>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-8b1f38f elementor-widget elementor-widget-text-editor\" data-id=\"8b1f38f\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>European legislation on pharmacovigilance requires all healthcare professionals and citizens to report any suspected adverse reaction (serious and non-serious, known and unknown).<\/p>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-7a2313c elementor-widget elementor-widget-text-editor\" data-id=\"7a2313c\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>A suspected adverse reaction may be reported by healthcare professionals and\/or citizens according to one of the following methods:<\/p>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-0c4f74e elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"0c4f74e\" data-element_type=\"widget\" data-widget_type=\"icon-list.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<ul class=\"elementor-icon-list-items\">\n\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-circle\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M256 8C119 8 8 119 8 256s111 248 248 248 248-111 248-248S393 8 256 8z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">directly online on the AIFA website at the address: <a target=\"_blanck\" href=\"https:\/\/www.aifa.gov.it\/content\/segnalazioni-reazioni-avverse\">https:\/\/www.aifa.gov.it\/en\/content\/<br>segnalazioni-reazioni-avverse<\/a><\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-circle\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M256 8C119 8 8 119 8 256s111 248 248 248 248-111 248-248S393 8 256 8z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">by filling out the reporting form at the following address: <a target=\"_blanck\" href=\"https:\/\/www.aifa.gov.it\/web\/guest\/moduli-segnalazione-reazioni-avverse\">https:\/\/www.aifa.gov.it\/en\/<br>moduli-segnalazione-reazioni-avverse<\/a> and sending it to the Pharmacovigilance Manager of your own structure via e-mail or fax<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-circle\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M256 8C119 8 8 119 8 256s111 248 248 248 248-111 248-248S393 8 256 8z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">irectly to the Marketing Authorization Holder (AIC) of the medicine that is suspected to have caused the adverse reaction.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t<\/ul>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5e229be elementor-widget elementor-widget-text-editor\" data-id=\"5e229be\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Before reporting an adverse reaction, we invite you to read <a href=\"https:\/\/www.caber.it\/wp-content\/uploads\/2025\/02\/information_for_the_processing_of_personal_data_rev2.pdf\"><span style=\"text-decoration: underline;\"><strong>the information<\/strong><\/span><\/a> on the processing of personal data pursuant to Regulation (EU) 2016\/679 for the activity of Pharmacovigilance.<\/p><p>The contact details for contacting the pharmacovigilance service and make a report are:<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-f7202a5 e-flex e-con-boxed e-con e-child\" data-id=\"f7202a5\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-89ab871 elementor-widget elementor-widget-button\" data-id=\"89ab871\" data-element_type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"mailto:farmacovigilanza@ibnsavio.it\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\"> <span class=\"material-symbols-outlined\"> email<\/span>farmacovigilanza@ibnsavio.it<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3eb8a53 elementor-widget elementor-widget-button\" data-id=\"3eb8a53\" data-element_type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"tel:+393289215572\" target=\"_blank\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\"> <span class=\"material-symbols-outlined\"> call <\/span>+39 328 92 15 572<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-dd0520d e-flex e-con-boxed e-con e-child\" data-id=\"dd0520d\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-031c9cd elementor-widget elementor-widget-button\" data-id=\"031c9cd\" data-element_type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/servizionline.aifa.gov.it\/schedasegnalazioni\/#\/\" target=\"_blank\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\"> <span class=\"material-symbols-outlined\"> medical_services <\/span>AIFA Portal<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Pharmacovigilance What is Pharmacovigilance Pharmacovigilance is the set of activities aimed at continuously evaluating all information relating to the safety of medicines in order to ensure that, for all medicines, there is a favorable benefit\/risk ratio for the population. In line with this general definition, the main objectives of Pharmacovigilance are: Promote and protect public [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":9077,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"class_list":["post-9083","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.2 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Pharmacovigilance - Caber<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.caber.it\/en\/compliance\/pharmacovigilance\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Pharmacovigilance - Caber\" \/>\n<meta property=\"og:description\" content=\"Pharmacovigilance What is Pharmacovigilance Pharmacovigilance is the set of activities aimed at continuously evaluating all information relating to the safety of medicines in order to ensure that, for all medicines, there is a favorable benefit\/risk ratio for the population. 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