{"id":25978,"date":"2022-10-24T09:17:05","date_gmt":"2022-10-24T14:17:05","guid":{"rendered":"https:\/\/en.ennov.com\/?p=25978"},"modified":"2022-10-24T09:17:06","modified_gmt":"2022-10-24T14:17:06","slug":"risk","status":"publish","type":"post","link":"https:\/\/dqdev.co\/ennov\/glossary\/risk\/","title":{"rendered":"Risk"},"content":{"rendered":"\n<p>The probability of developing an outcome (refers normally but not always to a negative outcome).<\/p>\n\n\n\n<p><strong>Absolute risk<\/strong>&nbsp;or Incidence Rate:&nbsp;The observed or calculated probability of the occurrence of an event&nbsp;in a population, without context. (e.g. 1 event in 100).&nbsp;<strong>Relative risk<\/strong>: Ratio of the risk in an exposed population (absolute risk) and an unexposed population (reference risk).&nbsp;<strong>Attributable risk<\/strong>&nbsp;(or excess risk): Difference between the risk in an exposed population (absolute risk) and the risk in an unexposed population (reference risk).&nbsp;<strong>Potential risk<\/strong>: An untoward occurrence for which the medicinal product can be suspected but where this association has not been confirmed, for instance:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Pre-clinical safety concerns that have not been observed in clinical studies<\/li><li>AEs observed but with a comparative effect (with placebo) not large enough to suggest a causal relationship<\/li><li>Event known to be associated with other products of the same class<\/li><\/ul>\n\n\n\n<p>Identified risk: Untoward occurrence for which there is evidence of an association with the medicinal product (usually been described in the SmPC). For instance,\u00a0<a href=\"https:\/\/en.ennov.com\/glossary\/adverse-drug-reaction-adr\/\">ADR<\/a>s:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Demonstrated in nonclinical studies and confirmed by clinical data<\/li><li>Observed in clinical trials or epidemiological studies for which the magnitude of the effect suggests a causal relationship<\/li><li>Suggested by spontaneous reports where causality is strongly supported by temporal relationship and biological plausibility<\/li><\/ul>\n\n\n\n<p>Important risk: A risk that could impact the risk-benefit profile of the product or have implications for public health. Any risk that could be included in the contraindications \/ precautions section of the product labelling should be considered important. Important risks are identified, characterized, and monitored in the\u00a0<a href=\"https:\/\/en.ennov.com\/glossary\/aggregate-reports\/\">DSUR<\/a>, the\u00a0RMP\u00a0and the\u00a0PSUR. An important identified risk usually warrants:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Evaluation in the pharmacovigilance plan of frequency, severity, seriousness, outcome under normal conditions of use, populations particularly at risk\u2026<\/li><li>Risk minimization activities: product information for instance<\/li><\/ul>\n","protected":false},"excerpt":{"rendered":"<p>The probability of developing an outcome (refers normally but not always to a negative outcome). Absolute risk&nbsp;or Incidence Rate:&nbsp;The observed or calculated probability of the occurrence of an event&nbsp;in a population, without context. (e.g. 1 event in 100).&nbsp;Relative risk: Ratio of the risk in an exposed population (absolute risk) and an unexposed population (reference risk).&nbsp;Attributable [&hellip;]<\/p>\n","protected":false},"author":232,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"content-type":"","footnotes":""},"categories":[180,199],"tags":[],"type_content":[179],"job":[],"employees_type":[],"class_list":["post-25978","post","type-post","status-publish","format-standard","hentry","category-glossary","category-r","type_content-glossaire","entry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v19.2.1 (Yoast SEO v27.4) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Risk<\/title>\n<meta name=\"description\" content=\"The probability of developing an outcome (refers normally but not always to a negative outcome). 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