{"id":5409,"date":"2022-03-17T14:30:39","date_gmt":"2022-03-17T18:30:39","guid":{"rendered":"https:\/\/spharm-inc.com\/wp2021\/?p=5409"},"modified":"2025-03-28T16:40:46","modified_gmt":"2025-03-28T20:40:46","slug":"quels-ajustements-doivent-etre-faits-pour-sadapter-aux-therapies-ciblees","status":"publish","type":"post","link":"https:\/\/spharm-inc.com\/fr\/quels-ajustements-doivent-etre-faits-pour-sadapter-aux-therapies-ciblees\/","title":{"rendered":"Quels ajustements doivent \u00eatre faits pour s\u2019adapter aux th\u00e9rapies cibl\u00e9es?"},"content":{"rendered":"\t\t
\n\t\t\t\t\t\t
\n\t\t\t\t\t\t
\n\t\t\t\t\t
\n\t\t\t
\n\t\t\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t\t\t\t\t\t

Quels ajustements doivent \u00eatre faits pour s\u2019adapter aux th\u00e9rapies cibl\u00e9es?<\/h1>

\u00a0<\/strong><\/p>

QUELS AJUSTEMENTS LES D\u00c9VELOPPEURS DE M\u00c9DICAMENTS ONT-ILS D\u00db FAIRE POUR RELEVER LES D\u00c9FIS ASSOCI\u00c9S AUX TH\u00c9RAPIES CIBL\u00c9ES?<\/strong><\/span><\/p>

Les ajustements-cl\u00e9s pour les d\u00e9veloppeurs de m\u00e9dicaments ont \u00e9t\u00e9 d\u2019accro\u00eetre la transparence avec les autorit\u00e9s et de demander des r\u00e9unions de pr\u00e9-soumission ou d\u2019avis scientifique. Ces r\u00e9unions sont d\u2019autant plus efficaces lorsque des experts locaux et des leaders d\u2019opinion sont appel\u00e9s \u00e0 participer.<\/p>

L\u2019objectif est de discuter des strat\u00e9gies et des exigences avec les autorit\u00e9s et de conclure des accords pour l\u2019avancement des activit\u00e9s de d\u00e9veloppement des m\u00e9dicaments concern\u00e9s. La rencontre avec Sant\u00e9 Canada n\u2019est pas une exigence, mais elle est fortement recommand\u00e9e pour les th\u00e9rapies novatrices qui n\u2019auraient pas le m\u00eame ensemble de donn\u00e9es cliniques qui serait habituellement requis ou attendu au Canada pour l\u2019acc\u00e8s au march\u00e9.<\/p>

En ce qui concerne le contenu de la soumission, contrairement aux id\u00e9es re\u00e7ues, Sant\u00e9 Canada suit des exigences similaires \u00e0 celles de la FDA et de l\u2019EMA. Par cons\u00e9quent, seuls des ajustements mineurs sont n\u00e9cessaires dans un dossier de la FDA ou de l\u2019EMA pour la soumission d\u2019une demande au Canada.

<\/p>


Pour toute question sur le processus canadien d\u2019examen et de r\u00e9glementation des m\u00e9dicaments qui n\u2019est pas couverte dans cette section, n\u2019h\u00e9sitez pas \u00e0 communiquer directement avec nous<\/a>.<\/h3>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"

Quels ajustements doivent \u00eatre faits pour s\u2019adapter aux th\u00e9rapies cibl\u00e9es? \u00a0 QUELS AJUSTEMENTS LES D\u00c9VELOPPEURS DE M\u00c9DICAMENTS ONT-ILS D\u00db FAIRE POUR RELEVER LES D\u00c9FIS ASSOCI\u00c9S AUX TH\u00c9RAPIES CIBL\u00c9ES? Les ajustements-cl\u00e9s pour les d\u00e9veloppeurs de m\u00e9dicaments ont \u00e9t\u00e9 d\u2019accro\u00eetre la transparence avec les autorit\u00e9s et de demander des r\u00e9unions de pr\u00e9-soumission ou d\u2019avis scientifique. Ces r\u00e9unions […]<\/p>\n","protected":false},"author":3,"featured_media":6561,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[242],"tags":[],"class_list":["post-5409","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-reglementation-de-sante-canada"],"acf":[],"yoast_head":"\nQuels ajustements n\u00e9cessaires pour th\u00e9rapies cibl\u00e9es ?<\/title>\n<meta name=\"description\" content=\"Comprenez quels ajustements Sant\u00e9 Canada exige pour mieux approuver et r\u00e9glementer les th\u00e9rapies cibl\u00e9es et personnalis\u00e9es.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/spharm-inc.com\/fr\/quels-ajustements-doivent-etre-faits-pour-sadapter-aux-therapies-ciblees\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Quels ajustements n\u00e9cessaires pour th\u00e9rapies cibl\u00e9es ?\" \/>\n<meta property=\"og:description\" content=\"Comprenez quels ajustements Sant\u00e9 Canada exige pour mieux approuver et r\u00e9glementer les th\u00e9rapies cibl\u00e9es et personnalis\u00e9es.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/spharm-inc.com\/fr\/quels-ajustements-doivent-etre-faits-pour-sadapter-aux-therapies-ciblees\/\" \/>\n<meta property=\"og:site_name\" content=\"Canada's Drug & Health Product Regulatory Experts\" \/>\n<meta property=\"article:published_time\" content=\"2022-03-17T18:30:39+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2025-03-28T20:40:46+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/spharm-inc.com\/wp-content\/uploads\/Quels-ajustements-doivent-etre-faits-pour-sadapter-aux-therapies-ciblees.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"1640\" \/>\n\t<meta property=\"og:image:height\" content=\"924\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"SPharm Canada\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:creator\" content=\"@2021-08-24 16:28:44\" \/>\n<meta name=\"twitter:label1\" content=\"\u00c9crit par\" \/>\n\t<meta name=\"twitter:data1\" content=\"SPharm Canada\" \/>\n\t<meta name=\"twitter:label2\" content=\"Dur\u00e9e de lecture estim\u00e9e\" \/>\n\t<meta name=\"twitter:data2\" content=\"2 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\/\/spharm-inc.com\/fr\/quels-ajustements-doivent-etre-faits-pour-sadapter-aux-therapies-ciblees\/\",\"url\":\"https:\/\/spharm-inc.com\/fr\/quels-ajustements-doivent-etre-faits-pour-sadapter-aux-therapies-ciblees\/\",\"name\":\"Quels ajustements n\u00e9cessaires pour th\u00e9rapies cibl\u00e9es ?\",\"isPartOf\":{\"@id\":\"https:\/\/spharm-inc.com\/fr\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\/\/spharm-inc.com\/fr\/quels-ajustements-doivent-etre-faits-pour-sadapter-aux-therapies-ciblees\/#primaryimage\"},\"image\":{\"@id\":\"https:\/\/spharm-inc.com\/fr\/quels-ajustements-doivent-etre-faits-pour-sadapter-aux-therapies-ciblees\/#primaryimage\"},\"thumbnailUrl\":\"https:\/\/spharm-inc.com\/wp-content\/uploads\/Quels-ajustements-doivent-etre-faits-pour-sadapter-aux-therapies-ciblees.jpg\",\"datePublished\":\"2022-03-17T18:30:39+00:00\",\"dateModified\":\"2025-03-28T20:40:46+00:00\",\"author\":{\"@id\":\"https:\/\/spharm-inc.com\/fr\/#\/schema\/person\/a37a21d64482aea4348baedfe3ed845a\"},\"description\":\"Comprenez quels ajustements Sant\u00e9 Canada exige pour mieux approuver et r\u00e9glementer les th\u00e9rapies cibl\u00e9es et personnalis\u00e9es.\",\"breadcrumb\":{\"@id\":\"https:\/\/spharm-inc.com\/fr\/quels-ajustements-doivent-etre-faits-pour-sadapter-aux-therapies-ciblees\/#breadcrumb\"},\"inLanguage\":\"fr-FR\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/spharm-inc.com\/fr\/quels-ajustements-doivent-etre-faits-pour-sadapter-aux-therapies-ciblees\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"fr-FR\",\"@id\":\"https:\/\/spharm-inc.com\/fr\/quels-ajustements-doivent-etre-faits-pour-sadapter-aux-therapies-ciblees\/#primaryimage\",\"url\":\"https:\/\/spharm-inc.com\/wp-content\/uploads\/Quels-ajustements-doivent-etre-faits-pour-sadapter-aux-therapies-ciblees.jpg\",\"contentUrl\":\"https:\/\/spharm-inc.com\/wp-content\/uploads\/Quels-ajustements-doivent-etre-faits-pour-sadapter-aux-therapies-ciblees.jpg\",\"width\":1640,\"height\":924},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\/\/spharm-inc.com\/fr\/quels-ajustements-doivent-etre-faits-pour-sadapter-aux-therapies-ciblees\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\/\/spharm-inc.com\/fr\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Quels ajustements doivent \u00eatre faits pour s\u2019adapter aux th\u00e9rapies cibl\u00e9es?\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\/\/spharm-inc.com\/fr\/#website\",\"url\":\"https:\/\/spharm-inc.com\/fr\/\",\"name\":\"Canada's Drug & Health Product Regulatory Experts\",\"description\":\"\",\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\/\/spharm-inc.com\/fr\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"fr-FR\"},{\"@type\":\"Person\",\"@id\":\"https:\/\/spharm-inc.com\/fr\/#\/schema\/person\/a37a21d64482aea4348baedfe3ed845a\",\"name\":\"SPharm Canada\",\"image\":{\"@type\":\"ImageObject\",\"inLanguage\":\"fr-FR\",\"@id\":\"https:\/\/spharm-inc.com\/fr\/#\/schema\/person\/image\/\",\"url\":\"https:\/\/secure.gravatar.com\/avatar\/6bd2a74a6f9b867851a1cfe6a675fbe0b0734774c6762861ddb4527adaf7e7c3?s=96&d=mm&r=g\",\"contentUrl\":\"https:\/\/secure.gravatar.com\/avatar\/6bd2a74a6f9b867851a1cfe6a675fbe0b0734774c6762861ddb4527adaf7e7c3?s=96&d=mm&r=g\",\"caption\":\"SPharm Canada\"},\"description\":\"With a quarter of a century of consistent and successful results, SPharm has become one of the leading Drug Regulatory Advisory firms in Canada. Drug companies from around the world count on SPharm to help them navigate the drug (and other health products) review & approval process in Canada. Avec un quart de si\u00e8cle de r\u00e9sultats et de succ\u00e8s constants , SPharm est devenue une entreprise de services de r\u00e9f\u00e9rence au Canada en strat\u00e9gie de d\u00e9veloppement de m\u00e9dicaments et affaires r\u00e9glementaires. Des compagnies pharmaceutiques \u00e0 travers le monde comptent sur SPharm pour faciliter le processus d'homologation de leurs m\u00e9dicaments (et autres produits de sant\u00e9) au Canada.\",\"sameAs\":[\"https:\/\/x.com\/2021-08-24 16:28:44\"],\"url\":\"https:\/\/spharm-inc.com\/fr\/author\/spharm-canada\/\"}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"Quels ajustements n\u00e9cessaires pour th\u00e9rapies cibl\u00e9es ?","description":"Comprenez quels ajustements Sant\u00e9 Canada exige pour mieux approuver et r\u00e9glementer les th\u00e9rapies cibl\u00e9es et personnalis\u00e9es.","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:\/\/spharm-inc.com\/fr\/quels-ajustements-doivent-etre-faits-pour-sadapter-aux-therapies-ciblees\/","og_locale":"fr_FR","og_type":"article","og_title":"Quels ajustements n\u00e9cessaires pour th\u00e9rapies cibl\u00e9es ?","og_description":"Comprenez quels ajustements Sant\u00e9 Canada exige pour mieux approuver et r\u00e9glementer les th\u00e9rapies cibl\u00e9es et personnalis\u00e9es.","og_url":"https:\/\/spharm-inc.com\/fr\/quels-ajustements-doivent-etre-faits-pour-sadapter-aux-therapies-ciblees\/","og_site_name":"Canada's Drug & Health Product Regulatory Experts","article_published_time":"2022-03-17T18:30:39+00:00","article_modified_time":"2025-03-28T20:40:46+00:00","og_image":[{"width":1640,"height":924,"url":"https:\/\/spharm-inc.com\/wp-content\/uploads\/Quels-ajustements-doivent-etre-faits-pour-sadapter-aux-therapies-ciblees.jpg","type":"image\/jpeg"}],"author":"SPharm Canada","twitter_card":"summary_large_image","twitter_creator":"@2021-08-24 16:28:44","twitter_misc":{"\u00c9crit par":"SPharm Canada","Dur\u00e9e de lecture estim\u00e9e":"2 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"WebPage","@id":"https:\/\/spharm-inc.com\/fr\/quels-ajustements-doivent-etre-faits-pour-sadapter-aux-therapies-ciblees\/","url":"https:\/\/spharm-inc.com\/fr\/quels-ajustements-doivent-etre-faits-pour-sadapter-aux-therapies-ciblees\/","name":"Quels ajustements n\u00e9cessaires pour th\u00e9rapies cibl\u00e9es ?","isPartOf":{"@id":"https:\/\/spharm-inc.com\/fr\/#website"},"primaryImageOfPage":{"@id":"https:\/\/spharm-inc.com\/fr\/quels-ajustements-doivent-etre-faits-pour-sadapter-aux-therapies-ciblees\/#primaryimage"},"image":{"@id":"https:\/\/spharm-inc.com\/fr\/quels-ajustements-doivent-etre-faits-pour-sadapter-aux-therapies-ciblees\/#primaryimage"},"thumbnailUrl":"https:\/\/spharm-inc.com\/wp-content\/uploads\/Quels-ajustements-doivent-etre-faits-pour-sadapter-aux-therapies-ciblees.jpg","datePublished":"2022-03-17T18:30:39+00:00","dateModified":"2025-03-28T20:40:46+00:00","author":{"@id":"https:\/\/spharm-inc.com\/fr\/#\/schema\/person\/a37a21d64482aea4348baedfe3ed845a"},"description":"Comprenez quels ajustements Sant\u00e9 Canada exige pour mieux approuver et r\u00e9glementer les th\u00e9rapies cibl\u00e9es et personnalis\u00e9es.","breadcrumb":{"@id":"https:\/\/spharm-inc.com\/fr\/quels-ajustements-doivent-etre-faits-pour-sadapter-aux-therapies-ciblees\/#breadcrumb"},"inLanguage":"fr-FR","potentialAction":[{"@type":"ReadAction","target":["https:\/\/spharm-inc.com\/fr\/quels-ajustements-doivent-etre-faits-pour-sadapter-aux-therapies-ciblees\/"]}]},{"@type":"ImageObject","inLanguage":"fr-FR","@id":"https:\/\/spharm-inc.com\/fr\/quels-ajustements-doivent-etre-faits-pour-sadapter-aux-therapies-ciblees\/#primaryimage","url":"https:\/\/spharm-inc.com\/wp-content\/uploads\/Quels-ajustements-doivent-etre-faits-pour-sadapter-aux-therapies-ciblees.jpg","contentUrl":"https:\/\/spharm-inc.com\/wp-content\/uploads\/Quels-ajustements-doivent-etre-faits-pour-sadapter-aux-therapies-ciblees.jpg","width":1640,"height":924},{"@type":"BreadcrumbList","@id":"https:\/\/spharm-inc.com\/fr\/quels-ajustements-doivent-etre-faits-pour-sadapter-aux-therapies-ciblees\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/spharm-inc.com\/fr\/"},{"@type":"ListItem","position":2,"name":"Quels ajustements doivent \u00eatre faits pour s\u2019adapter aux th\u00e9rapies cibl\u00e9es?"}]},{"@type":"WebSite","@id":"https:\/\/spharm-inc.com\/fr\/#website","url":"https:\/\/spharm-inc.com\/fr\/","name":"Canada's Drug & Health Product Regulatory Experts","description":"","potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/spharm-inc.com\/fr\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"fr-FR"},{"@type":"Person","@id":"https:\/\/spharm-inc.com\/fr\/#\/schema\/person\/a37a21d64482aea4348baedfe3ed845a","name":"SPharm Canada","image":{"@type":"ImageObject","inLanguage":"fr-FR","@id":"https:\/\/spharm-inc.com\/fr\/#\/schema\/person\/image\/","url":"https:\/\/secure.gravatar.com\/avatar\/6bd2a74a6f9b867851a1cfe6a675fbe0b0734774c6762861ddb4527adaf7e7c3?s=96&d=mm&r=g","contentUrl":"https:\/\/secure.gravatar.com\/avatar\/6bd2a74a6f9b867851a1cfe6a675fbe0b0734774c6762861ddb4527adaf7e7c3?s=96&d=mm&r=g","caption":"SPharm Canada"},"description":"With a quarter of a century of consistent and successful results, SPharm has become one of the leading Drug Regulatory Advisory firms in Canada. Drug companies from around the world count on SPharm to help them navigate the drug (and other health products) review & approval process in Canada. Avec un quart de si\u00e8cle de r\u00e9sultats et de succ\u00e8s constants , SPharm est devenue une entreprise de services de r\u00e9f\u00e9rence au Canada en strat\u00e9gie de d\u00e9veloppement de m\u00e9dicaments et affaires r\u00e9glementaires. Des compagnies pharmaceutiques \u00e0 travers le monde comptent sur SPharm pour faciliter le processus d'homologation de leurs m\u00e9dicaments (et autres produits de sant\u00e9) au Canada.","sameAs":["https:\/\/x.com\/2021-08-24 16:28:44"],"url":"https:\/\/spharm-inc.com\/fr\/author\/spharm-canada\/"}]}},"_links":{"self":[{"href":"https:\/\/spharm-inc.com\/fr\/wp-json\/wp\/v2\/posts\/5409","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/spharm-inc.com\/fr\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/spharm-inc.com\/fr\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/spharm-inc.com\/fr\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/spharm-inc.com\/fr\/wp-json\/wp\/v2\/comments?post=5409"}],"version-history":[{"count":1,"href":"https:\/\/spharm-inc.com\/fr\/wp-json\/wp\/v2\/posts\/5409\/revisions"}],"predecessor-version":[{"id":27845,"href":"https:\/\/spharm-inc.com\/fr\/wp-json\/wp\/v2\/posts\/5409\/revisions\/27845"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/spharm-inc.com\/fr\/wp-json\/wp\/v2\/media\/6561"}],"wp:attachment":[{"href":"https:\/\/spharm-inc.com\/fr\/wp-json\/wp\/v2\/media?parent=5409"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/spharm-inc.com\/fr\/wp-json\/wp\/v2\/categories?post=5409"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/spharm-inc.com\/fr\/wp-json\/wp\/v2\/tags?post=5409"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}