{"id":57690,"date":"2023-03-13T15:48:58","date_gmt":"2023-03-13T15:48:58","guid":{"rendered":"https:\/\/gxp-training.com\/online-course\/redaction-medicale-du-rapport-periodique-devaluation-benefice-risque-pbrer\/"},"modified":"2023-03-13T15:48:58","modified_gmt":"2023-03-13T14:48:58","slug":"redaction-medicale-du-rapport-periodique-devaluation-benefice-risque-pbrer","status":"publish","type":"product","link":"https:\/\/gxp-training.com\/fr\/online-course\/redaction-medicale-du-rapport-periodique-devaluation-benefice-risque-pbrer\/","title":{"rendered":"R\u00e9daction m\u00e9dicale du rapport p\u00e9riodique d&rsquo;\u00e9valuation b\u00e9n\u00e9fice-risque (PBRER)"},"content":{"rendered":"<p>Le rapport p\u00e9riodique d&rsquo;\u00e9valuation b\u00e9n\u00e9fice-risque ou PBRER est un document r\u00e9glementaire utilis\u00e9 comme norme commune pour le reporting p\u00e9riodique de l&rsquo;\u00e9valuation b\u00e9n\u00e9fice-risque des produits commercialis\u00e9s dans les r\u00e9gions ICH. Les titulaires d&rsquo;autorisation de mise sur le march\u00e9 (AMM) pr\u00e9parent le PBRER pour des produits pharmaceutiques sp\u00e9cifiques n\u00e9cessitant une approbation pour leur mise sur le march\u00e9 et le soumettent aux autorit\u00e9s r\u00e9glementaires, telles que la FDA et l&rsquo;EMA. Un rapport p\u00e9riodique d&rsquo;\u00e9valuation b\u00e9n\u00e9fice-risque r\u00e9sume l&rsquo;analyse des \u00e9v\u00e9nements ind\u00e9sirables, les nouveaux probl\u00e8mes de s\u00e9curit\u00e9 et les examens du profil b\u00e9n\u00e9fice-risque du produit. Ainsi, un PBRER examine la s\u00e9curit\u00e9 et l&rsquo;efficacit\u00e9 d&rsquo;un produit pharmaceutique sur une p\u00e9riode d\u00e9termin\u00e9e. Il examine \u00e9galement les modifications apport\u00e9es \u00e0 un produit particulier ou \u00e0 son \u00e9tiquetage.    <\/p>\n<div class=\"noOutline\" data-ba-index=\"3\" data-ba=\"lessonEdit.block\" data-block-id=\"cley39xfj000n286dzitfhuq4\">\n<div>\n<div class=\"block-text block-text--heading \">\n<div class=\"block-text__container\" data-ba=\"blocks.blockText\">\n<div class=\"block-text__row\">\n<div class=\"block-text__col brand--head\">\n<div class=\" brand--linkColor\">\n<div class=\"fr-view\"><\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<p>Dans cette formation, nous proposons une synth\u00e8se du sujet \u00e0 travers une exp\u00e9rience interactive en ligne. Ce contenu a \u00e9t\u00e9 \u00e9labor\u00e9 par une \u00e9quipe d&rsquo;experts en affaires r\u00e9glementaires dipl\u00f4m\u00e9s de la Northeastern University, Boston, dirig\u00e9e par un membre senior capable d&rsquo;articuler th\u00e9orie et pratique. <\/p>\n<p>&nbsp;<\/p>\n<h3>Programme :<\/h3>\n<p>&nbsp;<\/p>\n<p><strong>Le\u00e7on 1 : Introduction<\/strong><\/p>\n<p>&nbsp;<\/p>\n<p><strong>Le\u00e7on 2 : Format de r\u00e9daction du PBRER<\/strong><\/p>\n<p>&nbsp;<\/p>\n<p><strong>Le\u00e7on 3 : R\u00e9daction du contenu du PBRER<\/strong><\/p>\n<p>&nbsp;<\/p>\n<p><strong>Le\u00e7on 4 : R\u00e9daction de la conclusion et des annexes<\/strong><\/p>\n<p>&nbsp;<\/p>\n<p><strong>Conclusion<\/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>Le rapport p\u00e9riodique d&rsquo;\u00e9valuation b\u00e9n\u00e9fice-risque ou PBRER est un document r\u00e9glementaire utilis\u00e9 comme norme commune pour le reporting p\u00e9riodique de l&rsquo;\u00e9valuation b\u00e9n\u00e9fice-risque des produits commercialis\u00e9s dans les r\u00e9gions ICH. Les titulaires d&rsquo;autorisation de mise sur le march\u00e9 (AMM) pr\u00e9parent le PBRER pour des produits pharmaceutiques sp\u00e9cifiques n\u00e9cessitant une approbation pour leur mise sur le march\u00e9 [&hellip;]<\/p>\n","protected":false},"featured_media":43469,"template":"","meta":{"_acf_changed":false,"content-type":""},"product_brand":[],"product_cat":[255,263,258,267],"product_tag":[],"class_list":{"0":"post-57690","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-simple"},"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>PBRER et r\u00e9daction m\u00e9dicale : formation en ligne et certification<\/title>\n<meta name=\"description\" content=\"Formation en ligne et certification en r\u00e9daction m\u00e9dicale du rapport p\u00e9riodique d&#039;\u00e9valuation b\u00e9n\u00e9fice-risque (PBRER). Commencez votre formation d\u00e8s maintenant.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/gxp-training.com\/fr\/online-course\/redaction-medicale-du-rapport-periodique-devaluation-benefice-risque-pbrer\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"PBRER et r\u00e9daction m\u00e9dicale : formation en ligne et certification\" \/>\n<meta property=\"og:description\" content=\"Formation en ligne et certification en r\u00e9daction m\u00e9dicale du rapport p\u00e9riodique d&#039;\u00e9valuation b\u00e9n\u00e9fice-risque (PBRER). Commencez votre formation d\u00e8s maintenant.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/gxp-training.com\/fr\/online-course\/redaction-medicale-du-rapport-periodique-devaluation-benefice-risque-pbrer\/\" \/>\n<meta property=\"og:site_name\" content=\"GxP Training : Certified Online Courses for Life Sciences\" \/>\n<meta property=\"og:image\" content=\"https:\/\/gxp-training.com\/wp-content\/uploads\/2023\/03\/medical-writing.png\" \/>\n\t<meta property=\"og:image:width\" content=\"900\" \/>\n\t<meta property=\"og:image:height\" content=\"627\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Dur\u00e9e de lecture estim\u00e9e\" \/>\n\t<meta name=\"twitter:data1\" content=\"1 minute\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/gxp-training.com\\\/fr\\\/online-course\\\/redaction-medicale-du-rapport-periodique-devaluation-benefice-risque-pbrer\\\/\",\"url\":\"https:\\\/\\\/gxp-training.com\\\/fr\\\/online-course\\\/redaction-medicale-du-rapport-periodique-devaluation-benefice-risque-pbrer\\\/\",\"name\":\"PBRER et r\u00e9daction m\u00e9dicale : formation en ligne et certification\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/gxp-training.com\\\/fr\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/gxp-training.com\\\/fr\\\/online-course\\\/redaction-medicale-du-rapport-periodique-devaluation-benefice-risque-pbrer\\\/#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/gxp-training.com\\\/fr\\\/online-course\\\/redaction-medicale-du-rapport-periodique-devaluation-benefice-risque-pbrer\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/gxp-training.com\\\/wp-content\\\/uploads\\\/2023\\\/03\\\/medical-writing.png\",\"datePublished\":\"2023-03-13T15:48:58+00:00\",\"description\":\"Formation en ligne et certification en r\u00e9daction m\u00e9dicale du rapport p\u00e9riodique d'\u00e9valuation b\u00e9n\u00e9fice-risque (PBRER). Commencez votre formation d\u00e8s maintenant.\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/gxp-training.com\\\/fr\\\/online-course\\\/redaction-medicale-du-rapport-periodique-devaluation-benefice-risque-pbrer\\\/#breadcrumb\"},\"inLanguage\":\"fr-FR\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/gxp-training.com\\\/fr\\\/online-course\\\/redaction-medicale-du-rapport-periodique-devaluation-benefice-risque-pbrer\\\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"fr-FR\",\"@id\":\"https:\\\/\\\/gxp-training.com\\\/fr\\\/online-course\\\/redaction-medicale-du-rapport-periodique-devaluation-benefice-risque-pbrer\\\/#primaryimage\",\"url\":\"https:\\\/\\\/gxp-training.com\\\/wp-content\\\/uploads\\\/2023\\\/03\\\/medical-writing.png\",\"contentUrl\":\"https:\\\/\\\/gxp-training.com\\\/wp-content\\\/uploads\\\/2023\\\/03\\\/medical-writing.png\",\"width\":900,\"height\":627},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/gxp-training.com\\\/fr\\\/online-course\\\/redaction-medicale-du-rapport-periodique-devaluation-benefice-risque-pbrer\\\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Accueil\",\"item\":\"https:\\\/\\\/gxp-training.com\\\/fr\\\/page-daccueil\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Produits\",\"item\":\"https:\\\/\\\/gxp-training.com\\\/fr\\\/shop\\\/\"},{\"@type\":\"ListItem\",\"position\":3,\"name\":\"R\u00e9daction m\u00e9dicale du rapport p\u00e9riodique d&#8217;\u00e9valuation b\u00e9n\u00e9fice-risque (PBRER)\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/gxp-training.com\\\/fr\\\/#website\",\"url\":\"https:\\\/\\\/gxp-training.com\\\/fr\\\/\",\"name\":\"GxP Training : Certified Online Courses for Life Sciences\",\"description\":\"Online Trainings and Certified Courses in Regulatory Compliance for Pharmaceutical Experts\",\"publisher\":{\"@id\":\"https:\\\/\\\/gxp-training.com\\\/fr\\\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\\\/\\\/gxp-training.com\\\/fr\\\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"fr-FR\"},{\"@type\":\"Organization\",\"@id\":\"https:\\\/\\\/gxp-training.com\\\/fr\\\/#organization\",\"name\":\"GXP Training\",\"url\":\"https:\\\/\\\/gxp-training.com\\\/fr\\\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"fr-FR\",\"@id\":\"https:\\\/\\\/gxp-training.com\\\/fr\\\/#\\\/schema\\\/logo\\\/image\\\/\",\"url\":\"https:\\\/\\\/gxp-training.com\\\/wp-content\\\/uploads\\\/2022\\\/05\\\/logo-resize.png\",\"contentUrl\":\"https:\\\/\\\/gxp-training.com\\\/wp-content\\\/uploads\\\/2022\\\/05\\\/logo-resize.png\",\"width\":350,\"height\":100,\"caption\":\"GXP Training\"},\"image\":{\"@id\":\"https:\\\/\\\/gxp-training.com\\\/fr\\\/#\\\/schema\\\/logo\\\/image\\\/\"}}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"PBRER et r\u00e9daction m\u00e9dicale : formation en ligne et certification","description":"Formation en ligne et certification en r\u00e9daction m\u00e9dicale du rapport p\u00e9riodique d'\u00e9valuation b\u00e9n\u00e9fice-risque (PBRER). Commencez votre formation d\u00e8s maintenant.","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/gxp-training.com\/fr\/online-course\/redaction-medicale-du-rapport-periodique-devaluation-benefice-risque-pbrer\/","og_locale":"fr_FR","og_type":"article","og_title":"PBRER et r\u00e9daction m\u00e9dicale : formation en ligne et certification","og_description":"Formation en ligne et certification en r\u00e9daction m\u00e9dicale du rapport p\u00e9riodique d'\u00e9valuation b\u00e9n\u00e9fice-risque (PBRER). Commencez votre formation d\u00e8s maintenant.","og_url":"https:\/\/gxp-training.com\/fr\/online-course\/redaction-medicale-du-rapport-periodique-devaluation-benefice-risque-pbrer\/","og_site_name":"GxP Training : Certified Online Courses for Life Sciences","og_image":[{"width":900,"height":627,"url":"https:\/\/gxp-training.com\/wp-content\/uploads\/2023\/03\/medical-writing.png","type":"image\/png"}],"twitter_card":"summary_large_image","twitter_misc":{"Dur\u00e9e de lecture estim\u00e9e":"1 minute"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"WebPage","@id":"https:\/\/gxp-training.com\/fr\/online-course\/redaction-medicale-du-rapport-periodique-devaluation-benefice-risque-pbrer\/","url":"https:\/\/gxp-training.com\/fr\/online-course\/redaction-medicale-du-rapport-periodique-devaluation-benefice-risque-pbrer\/","name":"PBRER et r\u00e9daction m\u00e9dicale : formation en ligne et certification","isPartOf":{"@id":"https:\/\/gxp-training.com\/fr\/#website"},"primaryImageOfPage":{"@id":"https:\/\/gxp-training.com\/fr\/online-course\/redaction-medicale-du-rapport-periodique-devaluation-benefice-risque-pbrer\/#primaryimage"},"image":{"@id":"https:\/\/gxp-training.com\/fr\/online-course\/redaction-medicale-du-rapport-periodique-devaluation-benefice-risque-pbrer\/#primaryimage"},"thumbnailUrl":"https:\/\/gxp-training.com\/wp-content\/uploads\/2023\/03\/medical-writing.png","datePublished":"2023-03-13T15:48:58+00:00","description":"Formation en ligne et certification en r\u00e9daction m\u00e9dicale du rapport p\u00e9riodique d'\u00e9valuation b\u00e9n\u00e9fice-risque (PBRER). Commencez votre formation d\u00e8s maintenant.","breadcrumb":{"@id":"https:\/\/gxp-training.com\/fr\/online-course\/redaction-medicale-du-rapport-periodique-devaluation-benefice-risque-pbrer\/#breadcrumb"},"inLanguage":"fr-FR","potentialAction":[{"@type":"ReadAction","target":["https:\/\/gxp-training.com\/fr\/online-course\/redaction-medicale-du-rapport-periodique-devaluation-benefice-risque-pbrer\/"]}]},{"@type":"ImageObject","inLanguage":"fr-FR","@id":"https:\/\/gxp-training.com\/fr\/online-course\/redaction-medicale-du-rapport-periodique-devaluation-benefice-risque-pbrer\/#primaryimage","url":"https:\/\/gxp-training.com\/wp-content\/uploads\/2023\/03\/medical-writing.png","contentUrl":"https:\/\/gxp-training.com\/wp-content\/uploads\/2023\/03\/medical-writing.png","width":900,"height":627},{"@type":"BreadcrumbList","@id":"https:\/\/gxp-training.com\/fr\/online-course\/redaction-medicale-du-rapport-periodique-devaluation-benefice-risque-pbrer\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Accueil","item":"https:\/\/gxp-training.com\/fr\/page-daccueil\/"},{"@type":"ListItem","position":2,"name":"Produits","item":"https:\/\/gxp-training.com\/fr\/shop\/"},{"@type":"ListItem","position":3,"name":"R\u00e9daction m\u00e9dicale du rapport p\u00e9riodique d&#8217;\u00e9valuation b\u00e9n\u00e9fice-risque (PBRER)"}]},{"@type":"WebSite","@id":"https:\/\/gxp-training.com\/fr\/#website","url":"https:\/\/gxp-training.com\/fr\/","name":"GxP Training : Certified Online Courses for Life Sciences","description":"Online Trainings and Certified Courses in Regulatory Compliance for Pharmaceutical Experts","publisher":{"@id":"https:\/\/gxp-training.com\/fr\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/gxp-training.com\/fr\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"fr-FR"},{"@type":"Organization","@id":"https:\/\/gxp-training.com\/fr\/#organization","name":"GXP Training","url":"https:\/\/gxp-training.com\/fr\/","logo":{"@type":"ImageObject","inLanguage":"fr-FR","@id":"https:\/\/gxp-training.com\/fr\/#\/schema\/logo\/image\/","url":"https:\/\/gxp-training.com\/wp-content\/uploads\/2022\/05\/logo-resize.png","contentUrl":"https:\/\/gxp-training.com\/wp-content\/uploads\/2022\/05\/logo-resize.png","width":350,"height":100,"caption":"GXP Training"},"image":{"@id":"https:\/\/gxp-training.com\/fr\/#\/schema\/logo\/image\/"}}]}},"_links":{"self":[{"href":"https:\/\/gxp-training.com\/fr\/wp-json\/wp\/v2\/product\/57690","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/gxp-training.com\/fr\/wp-json\/wp\/v2\/product"}],"about":[{"href":"https:\/\/gxp-training.com\/fr\/wp-json\/wp\/v2\/types\/product"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/gxp-training.com\/fr\/wp-json\/wp\/v2\/media\/43469"}],"wp:attachment":[{"href":"https:\/\/gxp-training.com\/fr\/wp-json\/wp\/v2\/media?parent=57690"}],"wp:term":[{"taxonomy":"product_brand","embeddable":true,"href":"https:\/\/gxp-training.com\/fr\/wp-json\/wp\/v2\/product_brand?post=57690"},{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/gxp-training.com\/fr\/wp-json\/wp\/v2\/product_cat?post=57690"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/gxp-training.com\/fr\/wp-json\/wp\/v2\/product_tag?post=57690"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}