{"id":3512,"date":"2021-02-25T08:55:54","date_gmt":"2021-02-25T08:55:54","guid":{"rendered":"https:\/\/osmr.ro\/?p=3512"},"modified":"2021-05-19T09:04:31","modified_gmt":"2021-05-19T09:04:31","slug":"notificare-emvo-actualizare-privind-alertele-a7-2","status":"publish","type":"post","link":"https:\/\/osmr.ro\/en\/notificare-emvo-actualizare-privind-alertele-a7-2\/","title":{"rendered":"EMVO &#8211; LoA: Update on A7 Alerts"},"content":{"rendered":"<p><div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-1 nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--awb-border-radius-top-left:0px;--awb-border-radius-top-right:0px;--awb-border-radius-bottom-right:0px;--awb-border-radius-bottom-left:0px;--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-0 fusion_builder_column_1_1 1_1 fusion-one-full fusion-column-first fusion-column-last\" style=\"--awb-bg-size:cover;--awb-margin-bottom:0px;\"><div class=\"fusion-column-wrapper fusion-flex-column-wrapper-legacy\"><div class=\"fusion-text fusion-text-1\"><p>Privind subiectul alertelor A7, g\u0103si\u021bi mai jos cea mai recent\u0103 comunicare din partea EMVO.<\/p>\n<p><a href=\"https:\/\/emvo-medicines.eu\/new\/wp-content\/uploads\/EMVO_LoA_0175_20200224_Archiving-the-backlog-of-A7-alerts-remaining-in-the-retry-queue-from-2020.pdf\" target=\"_blank\" rel=\"noopener\">Notificare EMVO<\/a><\/p>\n<\/div><div class=\"fusion-clearfix\"><\/div><\/div><\/div><\/div><\/div><div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-2 fusion-flex-container nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--awb-border-radius-top-left:0px;--awb-border-radius-top-right:0px;--awb-border-radius-bottom-right:0px;--awb-border-radius-bottom-left:0px;--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"max-width:1248px;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-1 fusion_builder_column_1_1 1_1 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:100%;--awb-margin-top-large:0px;--awb-spacing-right-large:1.92%;--awb-margin-bottom-large:30px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-2\"><p>We recently confirmed that the backlog of A7 alerts in the EU Hub retry queue had been cleared. However, how older items \u2014 in the queue from 2020 \u2014 are to be processed was still under discussion.<\/p>\n<p>After further dialogue with our Stakeholders and NMVOs, we have decided to archive and drain these outdated items from the queue without propagation.<\/p>\n<p>None of the queue information will be lost. The full audit history will remain available in the event of an investigation. From a risk perspective, none of these older items would have resulted in an alert notification that would have been practical to investigate or now possible to apply corrective measures.<\/p>\n<p>We are all aware that the majority of current alerts generated are either false positive or technical in nature.<\/p>\n<p>After such a long period of time since generation, these older items, if forwarded, would only result in an excessive and eventually pointless investigational burden by OBPs and NMVOs alike.<\/p>\n<p>The pragmatic approach has therefore been agreed whereby these items will be archived within the EU Hub and will remain fully available for inspection in the event of an investigation.<\/p>\n<\/div><\/div><\/div><\/div><\/div><\/p>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":6,"featured_media":907,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[84,24],"tags":[],"class_list":["post-3512","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-istoric-notificari-emvo","category-stiri"],"translation":{"provider":"WPGlobus","version":"3.0.3","language":"en","enabled_languages":["ro","en"],"languages":{"ro":{"title":true,"content":true,"excerpt":false},"en":{"title":true,"content":false,"excerpt":false}}},"_links":{"self":[{"href":"https:\/\/osmr.ro\/en\/wp-json\/wp\/v2\/posts\/3512","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/osmr.ro\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/osmr.ro\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/osmr.ro\/en\/wp-json\/wp\/v2\/users\/6"}],"replies":[{"embeddable":true,"href":"https:\/\/osmr.ro\/en\/wp-json\/wp\/v2\/comments?post=3512"}],"version-history":[{"count":8,"href":"https:\/\/osmr.ro\/en\/wp-json\/wp\/v2\/posts\/3512\/revisions"}],"predecessor-version":[{"id":3515,"href":"https:\/\/osmr.ro\/en\/wp-json\/wp\/v2\/posts\/3512\/revisions\/3515"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/osmr.ro\/en\/wp-json\/wp\/v2\/media\/907"}],"wp:attachment":[{"href":"https:\/\/osmr.ro\/en\/wp-json\/wp\/v2\/media?parent=3512"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/osmr.ro\/en\/wp-json\/wp\/v2\/categories?post=3512"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/osmr.ro\/en\/wp-json\/wp\/v2\/tags?post=3512"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}