{"id":6340,"date":"2023-07-19T15:44:19","date_gmt":"2023-07-19T13:44:19","guid":{"rendered":"https:\/\/www.pharmaeducationcenter.it\/?post_type=product&p=6340"},"modified":"2025-06-11T16:09:03","modified_gmt":"2025-06-11T14:09:03","slug":"signal-detection","status":"publish","type":"product","link":"https:\/\/www.pharmaeducationcenter.it\/en\/trainings\/pharmacovigilance\/signal-detection\/","title":{"rendered":"Signal Detection"},"content":{"rendered":"

Recently, some of the most common critical findings in regulatory pharmacovigilance inspections are being given for signal detection and management, so the need to identify potential signals and risks in patients has increasing importance. The protection of patients through robust and clear methodologies for signal detection amidst the ever-increasing regulations requires companies to have trained and competent staff to perform such activities. This course will provide a detailed overview of all aspects of safety reviews and signal detection within a company and will cover signal evaluation for both innovator and generic products as required by regulations.<\/p>\n","protected":false},"excerpt":{"rendered":"

Recently, some of the most common critical findings in regulatory pharmacovigilance inspections are being given for signal detection and management, so the need to identify potential signals and risks in patients has increasing importance.<\/p>\n","protected":false},"featured_media":6354,"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":[116,118],"product_tag":[],"class_list":{"0":"post-6340","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-pharmacovigilance","7":"product_cat-trainings","8":"desktop-align-left","9":"tablet-align-left","10":"mobile-align-left","11":"ast-product-gallery-layout-horizontal-slider","12":"ast-product-gallery-with-no-image","13":"ast-magnify-disabled","14":"ast-product-single-variable","16":"first","17":"instock","18":"sale","19":"taxable","20":"shipping-taxable","21":"purchasable","22":"product-type-variable"},"acf":{"corso_new_label":false,"corso_promo_label":false,"corso_pdf_programma":"","corso_programma":"

Struttura del corso<\/h5>\r\n09:00 \u2013 16:30 COURSE SESSION DAY 1\r\n09:00 \u2013 12:30 COURSE SESSION DAY 2\r\n
Programma<\/h5>\r\n

Day 1<\/h3>\r\n9.00\u00a0What is signal detection and what are the regulatory requirements for signal detection?<\/strong>\r\nThe nature of signal detection and the various regulatory requirements will be presented.<\/em>\r\n\u2013 What organisation in a marketing authorisation holder should perform signal detection and how should they be staffed\r\n\u2022 Central safety organisation\r\n\u2022 Affiliates\r\n\u2022 Qualified signal detection staff\r\nQ&A time<\/em>\r\n\r\n9.30\u00a0Sources of signals<\/strong>\r\nDifferent sources of signals will be discussed<\/em>\r\n\u2022 Post-marketing safety databases\r\n\u2022 Epidemiology studies\r\n\u2022 Clinical trials\r\n\u2022 Toxicology and pharmacology\r\n\u2022 Literature\r\n\u2022 Others\r\nQ&A time<\/em>\r\n\r\n10.00\u00a0How do regulators themselves perform signal detection<\/strong>\r\nThe approach to signalling by different regulators will be discussed<\/em>\r\n\u2022 EMA\r\n\u2022 Local EU regulators\r\n\u2022 FDA\r\n\u2022 Others\r\nQ&A time<\/em>\r\n\r\n10:20\u00a0BREAK<\/em>\r\n\r\n10:40\u00a0Use of safety databases for signal detection<\/strong>\r\nThe theoretical basis of signal detection from post-marketing safety databases and their appropriate use will be discussed<\/em>\r\n\u2022 Qualitative signal detection\r\n\u2022 Quantitative signal detection\r\n\u2013 Disproportionality analyses\r\n\u2022 Longitudinal analyses\r\nQ&A time<\/em>\r\n\r\n11:10\u00a0End of morning session<\/em>\r\n\r\n14:30 Start of afternoon session\r\n\r\n14:35\u00a0Using Eudravigilance and EVDAS for signal detection<\/strong>\r\nThe use of Eudravigilance and EVDAS. practical aspects of use of Eudravigilance and EVDAS will be presented<\/em>\r\n\r\n16:15\u00a0Q&A time<\/em>\r\n\r\n16:30 Closure of day one<\/em>\r\n\r\n \r\n

Day 2<\/em><\/h3>\r\n9.00\u00a0Assessment of signals by marketing authorisation holders<\/strong>\r\nHow signals assessed will be discussed<\/em>\r\n\u2022 Validating a signal\r\n\u2022 Prioritization of a signal\r\n\u2022 Investigation of a signal\r\n\u2022 Closing a signal\r\nQ&A time<\/em>\r\n\r\n09.40\u00a0Link between signal detection and the PSUR and risk management plan<\/strong>\r\nThe important links between signal detection, PSURs, drug label and risk management plan will be reviewed<\/em>\r\n\r\n10:00\u00a0Audit and inspection of signal detection activities\r\n<\/strong>Appropriate approaches to ensure quality of signal detection activities will be presented<\/em>\r\n\u2022 Quality system for signal detection\r\n\u2013 Key Performance Indicators\r\n\u2022 What to audit\r\n\u2022 Pharmacovigilance inspectors assessment of signal detection\r\nQ&A time<\/em>\r\n\r\n10.25\u00a0BREAK<\/em>\r\n\r\n10.45\u00a0Exercise<\/strong>\r\nDelegates will be provided with data concerning signal activities to discuss together to determine the appropriate signal status that the data supports. This will be followed by discussion of the conclusions proposed.<\/em>\r\n\r\n11:45\u00a0Signal detection during clinical development of new chemical entity<\/strong>\r\nWhat role does formal signal detection have during the clinical development of a medicine and how best to document this will be discussed\r\n<\/em>Q&A time<\/em>\r\n\r\n12.00\u00a0What makes a good signal detection system<\/strong>\r\nA summary of considerations to ensure signal detection to the appropriate standards can be achieved.<\/em>\r\n\r\n12:20\u00a0Final questions session<\/em>\r\n\r\n12:30\u00a0Closure of the course<\/em>","corso_target":"
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\r\n\r\nFor professionals working in the following areas:\r\n\u2022 Pharmacovigilance\r\n\u2022 Drug Safety and Risk Management\r\n\u2022 Signal Management and Safety Science\r\n\u2022 Pharmacoepidemiology\r\n\u2022 Quality and Compliance\r\n\r\n<\/div>\r\n<\/div>\r\n<\/div>\r\n<\/div>\r\n<\/div>\r\n<\/div>\r\n<\/div>\r\n<\/div>\r\n<\/div>\r\n<\/div>\r\n<\/div>\r\n<\/div>\r\n<\/div>\r\n<\/div>","corso_competenze":[{"corso_competenze_item":"Apply the concepts and principles of signal management in PV and implement or improve this process in their own organisation"},{"corso_competenze_item":"Understand different approaches to signal management that are followed by various organisations"},{"corso_competenze_item":"Understand different approaches to signal detection for different medicines"},{"corso_competenze_item":"Understand the concept of signal detection algorithm (SDA), signal of disproportionate reporting (SDR) and its use in EVDAS"},{"corso_competenze_item":"Learn how to use and implement EVDAS into signal management process"},{"corso_competenze_item":"Understand the role of signal detection in the assessment of emerging safety profiles of medicine"},{"corso_competenze_item":"Understand the regulatory expectations in different geographic regions"}]},"_links":{"self":[{"href":"https:\/\/www.pharmaeducationcenter.it\/en\/wp-json\/wp\/v2\/product\/6340","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\/6354"}],"wp:attachment":[{"href":"https:\/\/www.pharmaeducationcenter.it\/en\/wp-json\/wp\/v2\/media?parent=6340"}],"wp:term":[{"taxonomy":"product_brand","embeddable":true,"href":"https:\/\/www.pharmaeducationcenter.it\/en\/wp-json\/wp\/v2\/product_brand?post=6340"},{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/www.pharmaeducationcenter.it\/en\/wp-json\/wp\/v2\/product_cat?post=6340"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/www.pharmaeducationcenter.it\/en\/wp-json\/wp\/v2\/product_tag?post=6340"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}