{"id":198,"date":"2026-07-07T12:42:27","date_gmt":"2026-07-07T10:42:27","guid":{"rendered":"https:\/\/www.pqra.gr\/signal-detection-turning-safety-data-into-action\/"},"modified":"2026-07-07T12:45:49","modified_gmt":"2026-07-07T10:45:49","slug":"signal-detection-turning-safety-data-into-action","status":"publish","type":"post","link":"https:\/\/www.pqra.gr\/el\/signal-detection-turning-safety-data-into-action\/","title":{"rendered":"Signal Detection: Turning Safety Data into Action"},"content":{"rendered":"<p style=\"font-size:19px;line-height:1.7;color:#33414d;\"><strong>Behind every label update and safety warning is a process that turns scattered adverse-event reports into a clear signal. Getting signal detection right is central to patient safety &mdash; and to staying compliant.<\/strong><\/p>\n<p>Signal management is governed by GVP Module IX. A <strong>signal<\/strong> is information suggesting a new, potentially causal association between a medicine and an event &mdash; or a new aspect of a known one &mdash; that warrants further verification.<\/p>\n<h2>Where the data comes from<\/h2>\n<p>In the EU, signal detection draws on <strong>EudraVigilance<\/strong>, analysed through the EudraVigilance Data Analysis System (EVDAS). The standard output, the electronic Reaction Monitoring Report (eRMR), summarises disproportionality and case data for review.<\/p>\n<h2>The statistics behind the signal<\/h2>\n<p>Disproportionality analysis flags medicine&ndash;event pairs reported more often than expected. Common measures include:<\/p>\n<ul>\n<li><strong>PRR<\/strong> (Proportional Reporting Ratio) and <strong>ROR<\/strong> (Reporting Odds Ratio) &mdash; frequentist measures.<\/li>\n<li><strong>IC<\/strong> (Information Component) and <strong>EBGM<\/strong> &mdash; Bayesian measures that perform better with sparse data.<\/li>\n<\/ul>\n<p>Thresholds typically combine a disproportionality value with a minimum number of cases. Crucially, statistics only prioritise what a human should review &mdash; clinical judgement remains essential.<\/p>\n<h2>The signal management lifecycle<\/h2>\n<p>A validated process runs from <strong>detection<\/strong> to <strong>validation<\/strong> (do the data support a genuine new association?), <strong>confirmation<\/strong> at EU level, <strong>assessment and prioritisation<\/strong>, and finally <strong>action<\/strong> &mdash; a label change, a Direct Healthcare Professional Communication, an RMP update or a referral.<\/p>\n<h2>Who does what<\/h2>\n<p>MAHs continuously monitor their own products&#8217; data, validate signals and notify authorities &mdash; emerging safety issues within <strong>three working days<\/strong>, with routine monitoring on a risk-based basis at least every six months. The EMA and national authorities monitor EudraVigilance centrally, and the PRAC assesses confirmed signals and issues recommendations. Recent EU rules have formalised the obligation for all MAHs to monitor EudraVigilance for their products.<\/p>\n<h2>How PQRA helps<\/h2>\n<p>PQRA sets up and runs signal detection and the wider signal-management process, so emerging risks are caught early and handled to regulatory standard.<\/p>\n<p><strong><a href=\"\/el\/contact\/\">Strengthen your safety monitoring &rarr;<\/a><\/strong><\/p>","protected":false},"excerpt":{"rendered":"<p>Behind every label update and safety warning is a process that turns scattered adverse-event reports into a clear signal. Getting signal detection right is central to patient safety &mdash; and to staying compliant. Signal management is governed by GVP Module IX. A signal is information suggesting a new, potentially causal association between a medicine and [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":208,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"saved_in_kubio":false,"_kadence_starter_templates_imported_post":false,"_swpsp_post_exclude":false,"footnotes":""},"categories":[1],"tags":[],"class_list":["post-198","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-uncategorized"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.0 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Signal Detection: Turning Safety Data into Action - PQRA<\/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.pqra.gr\/el\/signal-detection-turning-safety-data-into-action\/\" \/>\n<meta property=\"og:locale\" content=\"el_GR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Signal Detection: Turning Safety Data into Action - PQRA\" \/>\n<meta property=\"og:description\" content=\"Behind every label update and safety warning is a process that turns scattered adverse-event reports into a clear signal. Getting signal detection right is central to patient safety &mdash; and to staying compliant. Signal management is governed by GVP Module IX. A signal is information suggesting a new, potentially causal association between a medicine and [&hellip;]\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.pqra.gr\/el\/signal-detection-turning-safety-data-into-action\/\" \/>\n<meta property=\"og:site_name\" content=\"PQRA\" \/>\n<meta property=\"article:published_time\" content=\"2026-07-07T10:42:27+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2026-07-07T10:45:49+00:00\" \/>\n<meta name=\"author\" content=\"admin\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"\u03a3\u03c5\u03bd\u03c4\u03ac\u03c7\u03b8\u03b7\u03ba\u03b5 \u03b1\u03c0\u03cc\" \/>\n\t<meta name=\"twitter:data1\" content=\"admin\" \/>\n\t<meta name=\"twitter:label2\" content=\"\u0395\u03ba\u03c4\u03b9\u03bc\u03ce\u03bc\u03b5\u03bd\u03bf\u03c2 \u03c7\u03c1\u03cc\u03bd\u03bf\u03c2 \u03b1\u03bd\u03ac\u03b3\u03bd\u03c9\u03c3\u03b7\u03c2\" \/>\n\t<meta name=\"twitter:data2\" content=\"2 \u03bb\u03b5\u03c0\u03c4\u03ac\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/www.pqra.gr\\\/signal-detection-turning-safety-data-into-action\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.pqra.gr\\\/signal-detection-turning-safety-data-into-action\\\/\"},\"author\":{\"name\":\"admin\",\"@id\":\"https:\\\/\\\/www.pqra.gr\\\/#\\\/schema\\\/person\\\/31e1a03125e7281efaddd7278681af2c\"},\"headline\":\"Signal Detection: Turning Safety Data into Action\",\"datePublished\":\"2026-07-07T10:42:27+00:00\",\"dateModified\":\"2026-07-07T10:45:49+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.pqra.gr\\\/signal-detection-turning-safety-data-into-action\\\/\"},\"wordCount\":331,\"commentCount\":0,\"publisher\":{\"@id\":\"https:\\\/\\\/www.pqra.gr\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/www.pqra.gr\\\/signal-detection-turning-safety-data-into-action\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/www.pqra.gr\\\/wp-content\\\/uploads\\\/2026\\\/07\\\/signal-detection-1.png\",\"articleSection\":[\"Uncategorized\"],\"inLanguage\":\"el\",\"potentialAction\":[{\"@type\":\"CommentAction\",\"name\":\"Comment\",\"target\":[\"https:\\\/\\\/www.pqra.gr\\\/signal-detection-turning-safety-data-into-action\\\/#respond\"]}]},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.pqra.gr\\\/signal-detection-turning-safety-data-into-action\\\/\",\"url\":\"https:\\\/\\\/www.pqra.gr\\\/signal-detection-turning-safety-data-into-action\\\/\",\"name\":\"Signal Detection: Turning Safety Data into Action - PQRA\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.pqra.gr\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/www.pqra.gr\\\/signal-detection-turning-safety-data-into-action\\\/#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/www.pqra.gr\\\/signal-detection-turning-safety-data-into-action\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/www.pqra.gr\\\/wp-content\\\/uploads\\\/2026\\\/07\\\/signal-detection-1.png\",\"datePublished\":\"2026-07-07T10:42:27+00:00\",\"dateModified\":\"2026-07-07T10:45:49+00:00\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/www.pqra.gr\\\/signal-detection-turning-safety-data-into-action\\\/#breadcrumb\"},\"inLanguage\":\"el\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/www.pqra.gr\\\/signal-detection-turning-safety-data-into-action\\\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"el\",\"@id\":\"https:\\\/\\\/www.pqra.gr\\\/signal-detection-turning-safety-data-into-action\\\/#primaryimage\",\"url\":\"https:\\\/\\\/www.pqra.gr\\\/wp-content\\\/uploads\\\/2026\\\/07\\\/signal-detection-1.png\",\"contentUrl\":\"https:\\\/\\\/www.pqra.gr\\\/wp-content\\\/uploads\\\/2026\\\/07\\\/signal-detection-1.png\",\"width\":1200,\"height\":630},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/www.pqra.gr\\\/signal-detection-turning-safety-data-into-action\\\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\\\/\\\/www.pqra.gr\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Signal Detection: Turning Safety Data into Action\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/www.pqra.gr\\\/#website\",\"url\":\"https:\\\/\\\/www.pqra.gr\\\/\",\"name\":\"PQRA\",\"description\":\"Your trusted partner in Pharma\",\"publisher\":{\"@id\":\"https:\\\/\\\/www.pqra.gr\\\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\\\/\\\/www.pqra.gr\\\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"el\"},{\"@type\":\"Organization\",\"@id\":\"https:\\\/\\\/www.pqra.gr\\\/#organization\",\"name\":\"PQRA\",\"url\":\"https:\\\/\\\/www.pqra.gr\\\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"el\",\"@id\":\"https:\\\/\\\/www.pqra.gr\\\/#\\\/schema\\\/logo\\\/image\\\/\",\"url\":\"https:\\\/\\\/www.pqra.gr\\\/wp-content\\\/uploads\\\/2026\\\/07\\\/pqra-logo-white.png\",\"contentUrl\":\"https:\\\/\\\/www.pqra.gr\\\/wp-content\\\/uploads\\\/2026\\\/07\\\/pqra-logo-white.png\",\"width\":594,\"height\":362,\"caption\":\"PQRA\"},\"image\":{\"@id\":\"https:\\\/\\\/www.pqra.gr\\\/#\\\/schema\\\/logo\\\/image\\\/\"}},{\"@type\":\"Person\",\"@id\":\"https:\\\/\\\/www.pqra.gr\\\/#\\\/schema\\\/person\\\/31e1a03125e7281efaddd7278681af2c\",\"name\":\"admin\",\"image\":{\"@type\":\"ImageObject\",\"inLanguage\":\"el\",\"@id\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/656b750ec6bc02db9de84dc3080e82be722c7777ef23ff04d6e8e7a0ac541a45?s=96&d=mm&r=g\",\"url\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/656b750ec6bc02db9de84dc3080e82be722c7777ef23ff04d6e8e7a0ac541a45?s=96&d=mm&r=g\",\"contentUrl\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/656b750ec6bc02db9de84dc3080e82be722c7777ef23ff04d6e8e7a0ac541a45?s=96&d=mm&r=g\",\"caption\":\"admin\"},\"sameAs\":[\"https:\\\/\\\/www.pqra.gr\"],\"url\":\"https:\\\/\\\/www.pqra.gr\\\/el\\\/author\\\/dgkikas_rwvrose8\\\/\"}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"Signal Detection: Turning Safety Data into Action - PQRA","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/www.pqra.gr\/el\/signal-detection-turning-safety-data-into-action\/","og_locale":"el_GR","og_type":"article","og_title":"Signal Detection: Turning Safety Data into Action - PQRA","og_description":"Behind every label update and safety warning is a process that turns scattered adverse-event reports into a clear signal. Getting signal detection right is central to patient safety &mdash; and to staying compliant. Signal management is governed by GVP Module IX. A signal is information suggesting a new, potentially causal association between a medicine and [&hellip;]","og_url":"https:\/\/www.pqra.gr\/el\/signal-detection-turning-safety-data-into-action\/","og_site_name":"PQRA","article_published_time":"2026-07-07T10:42:27+00:00","article_modified_time":"2026-07-07T10:45:49+00:00","author":"admin","twitter_card":"summary_large_image","twitter_misc":{"\u03a3\u03c5\u03bd\u03c4\u03ac\u03c7\u03b8\u03b7\u03ba\u03b5 \u03b1\u03c0\u03cc":"admin","\u0395\u03ba\u03c4\u03b9\u03bc\u03ce\u03bc\u03b5\u03bd\u03bf\u03c2 \u03c7\u03c1\u03cc\u03bd\u03bf\u03c2 \u03b1\u03bd\u03ac\u03b3\u03bd\u03c9\u03c3\u03b7\u03c2":"2 \u03bb\u03b5\u03c0\u03c4\u03ac"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.pqra.gr\/signal-detection-turning-safety-data-into-action\/#article","isPartOf":{"@id":"https:\/\/www.pqra.gr\/signal-detection-turning-safety-data-into-action\/"},"author":{"name":"admin","@id":"https:\/\/www.pqra.gr\/#\/schema\/person\/31e1a03125e7281efaddd7278681af2c"},"headline":"Signal Detection: Turning Safety Data into Action","datePublished":"2026-07-07T10:42:27+00:00","dateModified":"2026-07-07T10:45:49+00:00","mainEntityOfPage":{"@id":"https:\/\/www.pqra.gr\/signal-detection-turning-safety-data-into-action\/"},"wordCount":331,"commentCount":0,"publisher":{"@id":"https:\/\/www.pqra.gr\/#organization"},"image":{"@id":"https:\/\/www.pqra.gr\/signal-detection-turning-safety-data-into-action\/#primaryimage"},"thumbnailUrl":"https:\/\/www.pqra.gr\/wp-content\/uploads\/2026\/07\/signal-detection-1.png","articleSection":["Uncategorized"],"inLanguage":"el","potentialAction":[{"@type":"CommentAction","name":"Comment","target":["https:\/\/www.pqra.gr\/signal-detection-turning-safety-data-into-action\/#respond"]}]},{"@type":"WebPage","@id":"https:\/\/www.pqra.gr\/signal-detection-turning-safety-data-into-action\/","url":"https:\/\/www.pqra.gr\/signal-detection-turning-safety-data-into-action\/","name":"Signal Detection: Turning Safety Data into Action - PQRA","isPartOf":{"@id":"https:\/\/www.pqra.gr\/#website"},"primaryImageOfPage":{"@id":"https:\/\/www.pqra.gr\/signal-detection-turning-safety-data-into-action\/#primaryimage"},"image":{"@id":"https:\/\/www.pqra.gr\/signal-detection-turning-safety-data-into-action\/#primaryimage"},"thumbnailUrl":"https:\/\/www.pqra.gr\/wp-content\/uploads\/2026\/07\/signal-detection-1.png","datePublished":"2026-07-07T10:42:27+00:00","dateModified":"2026-07-07T10:45:49+00:00","breadcrumb":{"@id":"https:\/\/www.pqra.gr\/signal-detection-turning-safety-data-into-action\/#breadcrumb"},"inLanguage":"el","potentialAction":[{"@type":"ReadAction","target":["https:\/\/www.pqra.gr\/signal-detection-turning-safety-data-into-action\/"]}]},{"@type":"ImageObject","inLanguage":"el","@id":"https:\/\/www.pqra.gr\/signal-detection-turning-safety-data-into-action\/#primaryimage","url":"https:\/\/www.pqra.gr\/wp-content\/uploads\/2026\/07\/signal-detection-1.png","contentUrl":"https:\/\/www.pqra.gr\/wp-content\/uploads\/2026\/07\/signal-detection-1.png","width":1200,"height":630},{"@type":"BreadcrumbList","@id":"https:\/\/www.pqra.gr\/signal-detection-turning-safety-data-into-action\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/www.pqra.gr\/"},{"@type":"ListItem","position":2,"name":"Signal Detection: Turning Safety Data into Action"}]},{"@type":"WebSite","@id":"https:\/\/www.pqra.gr\/#website","url":"https:\/\/www.pqra.gr\/","name":"PQRA","description":"Your trusted partner in Pharma","publisher":{"@id":"https:\/\/www.pqra.gr\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/www.pqra.gr\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"el"},{"@type":"Organization","@id":"https:\/\/www.pqra.gr\/#organization","name":"PQRA","url":"https:\/\/www.pqra.gr\/","logo":{"@type":"ImageObject","inLanguage":"el","@id":"https:\/\/www.pqra.gr\/#\/schema\/logo\/image\/","url":"https:\/\/www.pqra.gr\/wp-content\/uploads\/2026\/07\/pqra-logo-white.png","contentUrl":"https:\/\/www.pqra.gr\/wp-content\/uploads\/2026\/07\/pqra-logo-white.png","width":594,"height":362,"caption":"PQRA"},"image":{"@id":"https:\/\/www.pqra.gr\/#\/schema\/logo\/image\/"}},{"@type":"Person","@id":"https:\/\/www.pqra.gr\/#\/schema\/person\/31e1a03125e7281efaddd7278681af2c","name":"admin","image":{"@type":"ImageObject","inLanguage":"el","@id":"https:\/\/secure.gravatar.com\/avatar\/656b750ec6bc02db9de84dc3080e82be722c7777ef23ff04d6e8e7a0ac541a45?s=96&d=mm&r=g","url":"https:\/\/secure.gravatar.com\/avatar\/656b750ec6bc02db9de84dc3080e82be722c7777ef23ff04d6e8e7a0ac541a45?s=96&d=mm&r=g","contentUrl":"https:\/\/secure.gravatar.com\/avatar\/656b750ec6bc02db9de84dc3080e82be722c7777ef23ff04d6e8e7a0ac541a45?s=96&d=mm&r=g","caption":"admin"},"sameAs":["https:\/\/www.pqra.gr"],"url":"https:\/\/www.pqra.gr\/el\/author\/dgkikas_rwvrose8\/"}]}},"jetpack_featured_media_url":"https:\/\/www.pqra.gr\/wp-content\/uploads\/2026\/07\/signal-detection-1.png","_links":{"self":[{"href":"https:\/\/www.pqra.gr\/el\/wp-json\/wp\/v2\/posts\/198","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.pqra.gr\/el\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.pqra.gr\/el\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.pqra.gr\/el\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.pqra.gr\/el\/wp-json\/wp\/v2\/comments?post=198"}],"version-history":[{"count":1,"href":"https:\/\/www.pqra.gr\/el\/wp-json\/wp\/v2\/posts\/198\/revisions"}],"predecessor-version":[{"id":209,"href":"https:\/\/www.pqra.gr\/el\/wp-json\/wp\/v2\/posts\/198\/revisions\/209"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.pqra.gr\/el\/wp-json\/wp\/v2\/media\/208"}],"wp:attachment":[{"href":"https:\/\/www.pqra.gr\/el\/wp-json\/wp\/v2\/media?parent=198"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.pqra.gr\/el\/wp-json\/wp\/v2\/categories?post=198"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.pqra.gr\/el\/wp-json\/wp\/v2\/tags?post=198"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}