{"id":57231,"date":"2022-05-24T11:14:54","date_gmt":"2022-05-24T09:14:54","guid":{"rendered":"https:\/\/gxp-training.com\/online-course\/gestion-des-rapports-periodiques-actualises-de-securite-psur\/"},"modified":"2022-05-24T11:14:54","modified_gmt":"2022-05-24T09:14:54","slug":"gestion-des-rapports-periodiques-actualises-de-securite-psur","status":"publish","type":"product","link":"https:\/\/gxp-training.com\/fr\/online-course\/gestion-des-rapports-periodiques-actualises-de-securite-psur\/","title":{"rendered":"Gestion des rapports p\u00e9riodiques actualis\u00e9s de s\u00e9curit\u00e9 (PSUR)"},"content":{"rendered":"<p>La gestion de la s\u00e9curit\u00e9 des m\u00e9dicaments et dispositifs m\u00e9dicaux approuv\u00e9s est un \u00e9l\u00e9ment crucial de la <a href=\"https:\/\/gxp-training.com\/fr\/gxp-courses\/pharmacovigilance\/\">pharmacovigilance<\/a>. Lorsqu\u2019un m\u00e9dicament ou un dispositif m\u00e9dical passe de l\u2019environnement contr\u00f4l\u00e9 des essais cliniques aux conditions vari\u00e9es du monde r\u00e9el, les rapports p\u00e9riodiques actualis\u00e9s de s\u00e9curit\u00e9 (PSUR) deviennent un outil cl\u00e9 pour surveiller et \u00e9valuer la balance b\u00e9n\u00e9fice-risque. <\/p>\n<p>Notre cours certifiant et accr\u00e9dit\u00e9 CPD \/ CEU, \u00ab Gestion des rapports p\u00e9riodiques actualis\u00e9s de s\u00e9curit\u00e9 (PSUR) \u00bb, vous guide \u00e0 travers la structure et le contenu de ces documents essentiels de pharmacovigilance. Il met en avant le r\u00f4le important d\u2019autorit\u00e9s r\u00e9glementaires telles que l\u2019Agence europ\u00e9enne des m\u00e9dicaments (EMA) et la Food and Drug Administration (FDA) des \u00c9tats-Unis dans la promotion de la s\u00e9curit\u00e9 publique gr\u00e2ce \u00e0 des rapports de mise \u00e0 jour de s\u00e9curit\u00e9 rigoureux. <\/p>\n<p>Ce cours propose une exp\u00e9rience d\u2019apprentissage en ligne interactive, synth\u00e9tisant les aspects cl\u00e9s de la gestion des PSUR. D\u00e9velopp\u00e9 par une \u00e9quipe d\u2019experts en affaires r\u00e9glementaires dipl\u00f4m\u00e9s de Northeastern University (Boston), le contenu du cours est \u00e9labor\u00e9 par un membre senior qui fait efficacement le lien entre la th\u00e9orie et l\u2019application concr\u00e8te. <\/p>\n<p>Rejoignez-nous pour explorer les subtilit\u00e9s des PSUR dans le cadre plus large de la pharmacovigilance et vous doter des connaissances n\u00e9cessaires pour renforcer la s\u00e9curit\u00e9, l\u2019efficacit\u00e9 et le succ\u00e8s commercial de vos produits. Ce cours vous permet non seulement de mieux comprendre et mettre en \u0153uvre les PSUR, mais aussi de valoriser votre profil professionnel gr\u00e2ce \u00e0 une certification reconnue mondialement et \u00e0 l\u2019accr\u00e9ditation CPD \/ CEU. <\/p>\n<p>&nbsp;<\/p>\n<h3>Programme<\/h3>\n<p>&nbsp;<\/p>\n<p><strong>Introduction<\/strong><\/p>\n<p>&nbsp;<\/p>\n<p><strong>Le\u00e7on 1 : Que sont les rapports p\u00e9riodiques actualis\u00e9s de s\u00e9curit\u00e9 (PSUR) ?<\/strong><\/p>\n<p>&nbsp;<\/p>\n<ul>\n<li>Pourquoi les PSUR sont-ils n\u00e9cessaires ?<\/li>\n<li>Principes directeurs de l\u2019\u00e9valuation b\u00e9n\u00e9fice-risque<\/li>\n<li>Principes de pr\u00e9paration des PSUR<\/li>\n<li>Quel est le contenu d\u2019un PSUR ?<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><strong>Le\u00e7on 2 : Format et contenu, partie 1 \u2013 Informations introductives &#038; sch\u00e9mas d\u2019exposition et d\u2019utilisation<\/strong><\/p>\n<p>&nbsp;<\/p>\n<ul>\n<li>Informations introductives<\/li>\n<li>Exposition dans les essais cliniques<\/li>\n<li>Exposition issue de l\u2019exp\u00e9rience post-commercialisation<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><strong>Le\u00e7on 3 : Format et contenu, partie 2 \u2013 R\u00e9sultats significatifs issus des rapports et des \u00e9tudes<\/strong><\/p>\n<p>&nbsp;<\/p>\n<ul>\n<li>R\u00e9sum\u00e9 des \u00e9v\u00e9nements ind\u00e9sirables<\/li>\n<li>R\u00e9sultats des essais cliniques pendant l\u2019intervalle de d\u00e9claration<\/li>\n<li>R\u00e9sultats des<a href=\"https:\/\/gxp-training.com\/online-course\/gxp0629-nis-module-1-general-principles\/\"> \u00e9tudes non interventionnelles<\/a><\/li>\n<li>Autres sources<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><strong>Le\u00e7on 4 : Format et contenu, partie 3 \u2013 Signaux et \u00e9valuation b\u00e9n\u00e9fice-risque<\/strong><\/p>\n<p>&nbsp;<\/p>\n<ul>\n<li>Signaux<\/li>\n<li>Caract\u00e9risation des risques<\/li>\n<li>\u00c9valuation des b\u00e9n\u00e9fices<\/li>\n<li>Analyse b\u00e9n\u00e9fice-risque<\/li>\n<li>Conclusion et annexes<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><strong>Le\u00e7on 5 : Maintien de la qualit\u00e9 et soumission des PSUR<\/strong><\/p>\n<p>&nbsp;<\/p>\n<ul>\n<li>Maintien de la qualit\u00e9<\/li>\n<li>Fr\u00e9quence de soumission<\/li>\n<li>Exigences particuli\u00e8res de soumission<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><strong>Le\u00e7on 6 : \u00c9valuation des PSUR et actions ult\u00e9rieures<\/strong><\/p>\n<p>&nbsp;<\/p>\n<ul>\n<li>Qui r\u00e9alise l\u2019\u00e9valuation ?<\/li>\n<li><a href=\"https:\/\/gxp-training.com\/fr\/online-course\/gestion-des-risques-qualite\/\">Plan de gestion des risques et minimisation des risques<\/a><\/li>\n<li>En savoir plus sur la modification du produit<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><strong>Glossaire<\/strong><\/p>\n<p>&nbsp;<\/p>\n<p><strong>Conclusion<\/strong><\/p>\n<p>&nbsp;<\/p>\n<p><strong>Quiz<\/strong><\/p>\n","protected":false},"excerpt":{"rendered":"<p>La gestion de la s\u00e9curit\u00e9 des m\u00e9dicaments et dispositifs m\u00e9dicaux approuv\u00e9s est un \u00e9l\u00e9ment crucial de la pharmacovigilance. Lorsqu\u2019un m\u00e9dicament ou un dispositif m\u00e9dical passe de l\u2019environnement contr\u00f4l\u00e9 des essais cliniques aux conditions vari\u00e9es du monde r\u00e9el, les rapports p\u00e9riodiques actualis\u00e9s de s\u00e9curit\u00e9 (PSUR) deviennent un outil cl\u00e9 pour surveiller et \u00e9valuer la balance b\u00e9n\u00e9fice-risque. [&hellip;]<\/p>\n","protected":false},"featured_media":44133,"template":"","meta":{"_acf_changed":false,"content-type":""},"product_brand":[],"product_cat":[255,263,258,267],"product_tag":[],"class_list":{"0":"post-57231","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-affaires-reglementaires","7":"product_cat-organisme-de-recherche-sous-contrat-cro","8":"product_cat-pharmaceutique","9":"product_cat-pharmacovigilance","11":"first","12":"instock","13":"taxable","14":"shipping-taxable","15":"purchasable","16":"product-type-subscription"},"bundled_by":[],"bundle_stock_status":"instock","bundle_stock_quantity":null,"bundle_virtual":false,"bundle_layout":"","bundle_add_to_cart_form_location":"","bundle_editable_in_cart":false,"bundle_sold_individually_context":"","bundle_item_grouping":"","bundle_min_size":"","bundle_max_size":"","bundle_price":[],"bundled_items":[],"bundle_sell_ids":[],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Formation \u00e0 la gestion des rapports p\u00e9riodiques actualis\u00e9s de s\u00e9curit\u00e9 (PSUR)<\/title>\n<meta name=\"description\" content=\"Apprenez la gestion des rapports p\u00e9riodiques actualis\u00e9s de s\u00e9curit\u00e9 (PSUR) gr\u00e2ce \u00e0 notre cours certifiant en ligne. 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