{"id":57182,"date":"2022-05-27T12:06:02","date_gmt":"2022-05-27T10:06:02","guid":{"rendered":"https:\/\/gxp-training.com\/online-course\/veille-et-gestion-de-la-litterature-pour-les-activites-de-pharmacovigilance\/"},"modified":"2022-05-27T12:06:02","modified_gmt":"2022-05-27T10:06:02","slug":"veille-et-gestion-de-la-litterature-pour-les-activites-de-pharmacovigilance","status":"publish","type":"product","link":"https:\/\/gxp-training.com\/fr\/online-course\/veille-et-gestion-de-la-litterature-pour-les-activites-de-pharmacovigilance\/","title":{"rendered":"Veille et gestion de la litt\u00e9rature pour les activit\u00e9s de pharmacovigilance"},"content":{"rendered":"<p>Les essais cliniques ne peuvent montrer que les r\u00e9sultats de l\u2019administration de m\u00e9dicaments ou de dispositifs th\u00e9rapeutiques \u00e0 des membres d\u2019une population contr\u00f4l\u00e9e, g\u00e9n\u00e9ralement dans des cadres contr\u00f4l\u00e9s. Cependant, une fois le produit approuv\u00e9 pour la commercialisation, des variations sont in\u00e9vitables dans la mani\u00e8re dont les diff\u00e9rentes personnes l\u2019assimilent. Par cons\u00e9quent, la <a href=\"https:\/\/gxp-training.com\/fr\/online-course\/bonnes-pratiques-de-pharmacovigilance-gvp\/\">pharmacovigilance<\/a> est une extension n\u00e9cessaire du processus de d\u00e9couverte de m\u00e9dicaments o\u00f9 l\u2019utilisation d\u2019un nouveau m\u00e9dicament ou dispositif est surveill\u00e9e en vie r\u00e9elle.  <\/p>\n<p>Ce cours pr\u00e9sente aux \u00e9tudiants les diff\u00e9rents rapports utilis\u00e9s pour compiler les donn\u00e9es de pharmacovigilance active et passive et souligne l\u2019importance d\u2019agences telles que la FDA et la MHRA dans la collecte de ces informations.<\/p>\n<p>&nbsp;<\/p>\n<p>Dans ce cours, nous proposons une synth\u00e8se du sujet \u00e0 travers une exp\u00e9rience interactive en ligne. Ce support a \u00e9t\u00e9 con\u00e7u par une \u00e9quipe d\u2019experts en affaires r\u00e9glementaires dipl\u00f4m\u00e9s de l\u2019Universit\u00e9 Northeastern de Boston, pilot\u00e9e par un membre senior capable d\u2019articuler th\u00e9orie et pratique. <\/p>\n<p>&nbsp;<\/p>\n<h3><\/h3>\n<h3>Programme<\/h3>\n<p>&nbsp;<\/p>\n<p><strong>Introduction<\/strong><\/p>\n<p>&nbsp;<\/p>\n<ul>\n<li>Objectifs de la pharmacovigilance<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><strong>Le\u00e7on 1 : Veille de la litt\u00e9rature scientifique \u00e0 des fins de pharmacovigilance<\/strong><\/p>\n<p>&nbsp;<\/p>\n<ul>\n<li>R\u00f4le de la litt\u00e9rature scientifique et m\u00e9dicale en pharmacovigilance<\/li>\n<li>Surveillance passive (pharmacovigilance)<\/li>\n<li>Notification spontan\u00e9e des effets ind\u00e9sirables des m\u00e9dicaments<\/li>\n<li>Identification des signaux de s\u00e9curit\u00e9 pour la notification spontan\u00e9e<\/li>\n<li>Rapports de s\u00e9ries de cas<\/li>\n<li>\u00c9valuation de la causalit\u00e9<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><strong>Le\u00e7on 2 : Rapports de synth\u00e8se<\/strong><\/p>\n<p>&nbsp;<\/p>\n<ul>\n<li>Rapports p\u00e9riodiques actualis\u00e9s de s\u00e9curit\u00e9 (PSUR)<\/li>\n<li>L\u2019utilit\u00e9 des <a href=\"https:\/\/gxp-training.com\/online-course\/gxp1861-management-of-periodic-safety-update-reports\/\">rapports p\u00e9riodiques actualis\u00e9s de s\u00e9curit\u00e9<\/a><\/li>\n<li>Rapport p\u00e9riodique d\u2019\u00e9valuation b\u00e9n\u00e9fice-risque (PBRER)<\/li>\n<li>L\u2019utilit\u00e9 du rapport p\u00e9riodique d\u2019\u00e9valuation b\u00e9n\u00e9fice-risque<\/li>\n<li>Le plan de gestion des risques (PGR)<\/li>\n<li>Les activit\u00e9s de minimisation des risques<\/li>\n<li>Sp\u00e9cifications de pharmacovigilance<\/li>\n<li>Utilit\u00e9 du plan de gestion des risques<\/li>\n<li>Rapport actualis\u00e9 de s\u00e9curit\u00e9 au cours du d\u00e9veloppement (DSUR)<\/li>\n<li>L\u2019utilit\u00e9 du rapport actualis\u00e9 de s\u00e9curit\u00e9 au cours du d\u00e9veloppement<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><strong>Le\u00e7on 3 : Surveillance active (pharmacovigilance)<\/strong><\/p>\n<p>&nbsp;<\/p>\n<ul>\n<li>Registres de patients<\/li>\n<li>Activit\u00e9s de pharmacovigilance<\/li>\n<li>Approche conceptuelle \u2013 Domaines cl\u00e9s pour mesurer l\u2019impact des activit\u00e9s de pharmacovigilance<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><strong>Le\u00e7on 4 : Efficacit\u00e9 des activit\u00e9s de minimisation des risques<\/strong><\/p>\n<p>&nbsp;<\/p>\n<ul>\n<li>Efficacit\u00e9 des processus sp\u00e9cifiques de pharmacovigilance<\/li>\n<li>Facteurs favorisant l\u2019efficacit\u00e9 en pharmacovigilance<\/li>\n<li>Identification et d\u00e9veloppement de m\u00e9thodes analytiques<\/li>\n<li>Pourquoi surveiller la litt\u00e9rature m\u00e9dicale pour identifier les cas isol\u00e9s d\u2019effets ind\u00e9sirables ?<\/li>\n<li>Pourquoi effectuer des recherches bibliographiques ?<\/li>\n<li>La litt\u00e9rature comme source d\u2019effets ind\u00e9sirables : la thalidomide et les malformations cong\u00e9nitales<\/li>\n<li>D\u00e9fis de la veille de la litt\u00e9rature scientifique et m\u00e9dicale pour la pharmacovigilance<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><strong>Le\u00e7on 5 : Diff\u00e9rences de r\u00e9glementation<\/strong><\/p>\n<p>&nbsp;<\/p>\n<ul>\n<li>\u00c9laborer la strat\u00e9gie de recherche parfaite<\/li>\n<li>Le volume important de la litt\u00e9rature scientifique<\/li>\n<li>Inspections et audits<\/li>\n<li>Surveillance des revues en langue locale<\/li>\n<li>Mise en \u0153uvre des r\u00e9sultats MLM de l\u2019EMA<\/li>\n<li>Les arguments en faveur de l\u2019externalisation<\/li>\n<li>L\u2019externalisation n\u2019est pas sans risques<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><strong>Le\u00e7on 6 : Solutions logicielles pour la gestion de la litt\u00e9rature<\/strong><\/p>\n<p>&nbsp;<\/p>\n<ul>\n<li>Solution de gestion de la litt\u00e9rature : am\u00e9liorer la gestion du flux de travail et la conformit\u00e9 r\u00e9glementaire<\/li>\n<li>Solution de gestion de l\u2019information en ligne<\/li>\n<li>Que fait QUOSA ?<\/li>\n<li>\u00c0 qui s\u2019adresse QUOSA ?<\/li>\n<li>Pourquoi choisir QUOSA ?<\/li>\n<li>Comment fonctionne QUOSA ?<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><strong>Conclusion<\/strong><\/p>\n<p>&nbsp;<\/p>\n<p><strong>Acronymes<\/strong><\/p>\n<p>&nbsp;<\/p>\n<p><strong>Glossaire<\/strong><\/p>\n<p>&nbsp;<\/p>\n<p><strong>\u00c9valuation<\/strong><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Les essais cliniques ne peuvent montrer que les r\u00e9sultats de l\u2019administration de m\u00e9dicaments ou de dispositifs th\u00e9rapeutiques \u00e0 des membres d\u2019une population contr\u00f4l\u00e9e, g\u00e9n\u00e9ralement dans des cadres contr\u00f4l\u00e9s. Cependant, une fois le produit approuv\u00e9 pour la commercialisation, des variations sont in\u00e9vitables dans la mani\u00e8re dont les diff\u00e9rentes personnes l\u2019assimilent. Par cons\u00e9quent, la pharmacovigilance est une [&hellip;]<\/p>\n","protected":false},"featured_media":44663,"template":"","meta":{"_acf_changed":false,"content-type":""},"product_brand":[],"product_cat":[263,258,267],"product_tag":[],"class_list":{"0":"post-57182","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-organisme-de-recherche-sous-contrat-cro","7":"product_cat-pharmaceutique","8":"product_cat-pharmacovigilance","10":"first","11":"instock","12":"taxable","13":"shipping-taxable","14":"purchasable","15":"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>Litt\u00e9rature en pharmacovigilance - Cours en ligne et certification<\/title>\n<meta name=\"description\" content=\"Apprenez \u00e0 utiliser la litt\u00e9rature de mani\u00e8re appropri\u00e9e pour la pharmacovigilance. 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