{"id":1656,"date":"2018-05-18T16:31:17","date_gmt":"2018-05-18T14:31:17","guid":{"rendered":"https:\/\/p686699.mittwaldserver.info\/?p=1656"},"modified":"2025-03-20T13:06:27","modified_gmt":"2025-03-20T12:06:27","slug":"pharmakovigilance-screening","status":"publish","type":"post","link":"https:\/\/gimd.de\/en\/2018\/05\/18\/pharmakovigilance-screening\/","title":{"rendered":"Pharmakovigilance screening"},"content":{"rendered":"\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p>For numerous clients, we perform the <abbr title=\"Pharmacovigilance (drug safety) means the ongoing and systematic monitoring of the safety of a pharmaceutically manufactured drug, with the aim of discovering, assessing, and understanding its undesired effects, in order to take appropriate measures for risk minimization.\">pharmacovigilance<\/abbr> screening of medical literature. This service comprises all steps prescribed by the approval authorities, from the development and maintenance of suitable research strategies to creation of reportable data and forms.<\/p>\n<\/blockquote>\n\n\n\n<p><strong>Projektlaufzeit:<\/strong> laufend<\/p>\n\n\n\n<p><strong>Project duration: <\/strong>ongoing<br><br>Processing strictly observes the stipulations of the \u201c<a href=\"http:\/\/www.ema.europa.eu\/ema\/index.jsp?curl=pages\/regulation\/document_listing\/document_listing_000345.jsp\">Guideline on good pharmacovigilance practices (GVP)<\/a>\u201d. In detail, operations are adapted to specifications or processes already established at the client\u2019s, so that together, we will find as efficient and cost-effective a way as possible.<br><br>Screening with regard to drug safety particularly focuses on the following content aspects of the publications:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>undesirable drug reactions<\/li>\n\n\n\n<li>interactions with other drugs<\/li>\n\n\n\n<li>administration during pregnancy or breastfeeding period<\/li>\n\n\n\n<li>administration in childhood<\/li>\n\n\n\n<li>overdoses \/ poisonings<\/li>\n\n\n\n<li>drug abuse \/ dependency<\/li>\n\n\n\n<li>therapy failure<\/li>\n\n\n\n<li>misapplications \/ errors<\/li>\n\n\n\n<li><abbr title=\"Off-label-use indicates the prescription of a pharmaceutically manufactured drug beyond the use approved by the prescription regulation authorities.\">off-label use<\/abbr><\/li>\n\n\n\n<li>risks \/ risk factors<\/li>\n\n\n\n<li>unexpected therapeutic benefit<\/li>\n\n\n\n<li>occupational exposure<\/li>\n\n\n\n<li>other<\/li>\n<\/ul>\n\n\n\n<p>Screening is performed by specially trained GIMD staff, who analyze and process all relevant literature documents in such detail that, if necessary, an individual case report can be generated from them. Depending on client specifications, the documents may also be used for the compilation of <abbr title=\"Pharmaceutical companies are obliged to assess all side-effect reports and to submit regularly updated statements on the safety of drugs.\">\u201cperiodic safety update reports&#8221;<\/abbr>.<br><br>This complex type of analysis utilizes numerous <a href=\"https:\/\/gimd.de\/en\/software\/\">ARTIS modules<\/a>, especially multi-stage full-text analysis and the modules for controlling and documenting procedures. This ensures that even large numbers of documents can be processed within the prescribed short time limits. In order to guarantee the quality and consistency of the analysis results, crucial steps are carried out according to the four-eyes principle. Our quality management (QM) builds on long years of experience in this area and ensures the greatest possible transparency of the processes. The data collected in our QM system is then available for internal and external <abbr title=\"An audit has the purpose of verifying whether processes, requirements, and guidelines meet the prescribed standards.\">audits<\/abbr> at all times, which simultaneously enables constant improvement and a high reproducibility of screening results.<br><br>Another <a href=\"https:\/\/gimd.de\/en\/software\/\">ARTIS module<\/a> may be used for the semi-automatic execution, e.g. of author enquiries, etc., immensely reducing workloads and effort.<\/p>\n\n\n\n<p class=\"has-text-align-right\"><a href=\"https:\/\/gimd.de\/en\/contact\/\">Contact<\/a> <a href=\"https:\/\/gimd.de\/en\/category\/projects\/#projectsContent\">Show all<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>For numerous clients, we perform the pharmacovigilance screening of medical literature. This service comprises all steps prescribed by the approval [&hellip;]<\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"site-sidebar-layout":"default","site-content-layout":"","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":"","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-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":"","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-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":"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":""},"mobile":{"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":""}},"footnotes":""},"categories":[93,114,116,83,118,117,71,108,107],"tags":[],"class_list":["post-1656","post","type-post","status-publish","format-standard","hentry","category-databases","category-documenting","category-evaluating","category-pharmacovigilance","category-processing-editing","category-procuring","category-projects","category-researching","category-selecting"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.2 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Pharmakovigilance screening &#8211; GIMD<\/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:\/\/gimd.de\/en\/2018\/05\/18\/pharmakovigilance-screening\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Pharmakovigilance screening &#8211; GIMD\" \/>\n<meta property=\"og:description\" content=\"For numerous clients, we perform the pharmacovigilance screening of medical literature. 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