{"id":4502,"date":"2023-02-08T16:39:08","date_gmt":"2023-02-08T15:39:08","guid":{"rendered":"https:\/\/www.universalmedica.com\/?p=4502"},"modified":"2026-05-13T11:50:04","modified_gmt":"2026-05-13T09:50:04","slug":"linterpretation-du-jour-zero-j0-pour-les-icsr-issus-des-journaux-papiers-ou-dematerialises","status":"publish","type":"post","link":"https:\/\/www.universalmedica.com\/fr\/linterpretation-du-jour-zero-j0-pour-les-icsr-issus-des-journaux-papiers-ou-dematerialises\/","title":{"rendered":"L&rsquo;interpr\u00e9tation du JOUR ZERO (J0) pour les ICSR issus des journaux papiers ou d\u00e9mat\u00e9rialis\u00e9s"},"content":{"rendered":"<p>\u00ab\u00a0Les titulaires d\u2019AMM sont cens\u00e9s examiner et \u00e9valuer les rapports d&rsquo;effets ind\u00e9sirables pr\u00e9sum\u00e9s provenant de la litt\u00e9rature m\u00e9dicale afin d&rsquo;identifier et d&rsquo;enregistrer les rapports de s\u00e9curit\u00e9 des cas individuels (ICSR).\u00a0\u00bb<\/p>\n<p>Si un cas de pharmacovigilance est d\u00e9tect\u00e9 dans une revue, l&rsquo;horloge commence le JOUR ZERO, jour de la r\u00e9ception de la copie d\u00e9mat\u00e9rialis\u00e9e \/papier de la revue locale par l&rsquo;organisation\/le titulaire d\u2019AMM\/le demandeur. Le JOUR ZERO doit \u00eatre consid\u00e9r\u00e9e comme le jour de la r\u00e9alisation d&rsquo;une recherche documentaire dans une base de donn\u00e9es \u00e9lectronique.<\/p>\n<p>Pour en savoir plus, visitez : <a href=\"https:\/\/www.ema.europa.eu\/en\/coordination-pharmacovigilance-inspections-0#:~:text=day%20zero%20is%20the%20date,contractual%20arrangements%20with%20the%20organisation.\">Link<\/a><\/p>\n<p>&amp; Trouvez<\/p>\n<p>(Q&amp;R : Quel est le jour z\u00e9ro pour les ICSRs d\u00e9crits dans les journaux locaux physiques\/papier ?)<\/p>\n","protected":false},"excerpt":{"rendered":"<p>\u00ab\u00a0Les titulaires d\u2019AMM sont cens\u00e9s examiner et \u00e9valuer les rapports d&rsquo;effets ind\u00e9sirables pr\u00e9sum\u00e9s provenant de la litt\u00e9rature m\u00e9dicale afin d&rsquo;identifier et d&rsquo;enregistrer les rapports de s\u00e9curit\u00e9 des cas individuels (ICSR).\u00a0\u00bb Si un cas de pharmacovigilance est d\u00e9tect\u00e9 dans une revue, l&rsquo;horloge commence le JOUR ZERO, jour de la r\u00e9ception de la copie d\u00e9mat\u00e9rialis\u00e9e \/papier de [&hellip;]<\/p>\n","protected":false},"author":3,"featured_media":4503,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"categories":[135,134],"tags":[],"class_list":["post-4502","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-compliance-2","category-pharmacovigilance"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.6 - 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