{"id":1225,"date":"2022-03-15T17:09:37","date_gmt":"2022-03-15T09:09:37","guid":{"rendered":"https:\/\/regask.com\/?p=1225"},"modified":"2024-11-22T05:29:31","modified_gmt":"2024-11-21T21:29:31","slug":"preuves-du-monde-reel-allegations-de-gre-a-gre","status":"publish","type":"post","link":"https:\/\/regask.com\/fr\/real-world-evidence-otc-claims\/","title":{"rendered":"Comment les preuves du monde r\u00e9el ont soutenu la justification des revendications\u2026"},"content":{"rendered":"<p>Un leader de l&#039;industrie pharmaceutique souhaitait s&#039;appuyer sur des preuves concr\u00e8tes pour \u00e9tayer les all\u00e9gations d&#039;un produit en vente libre (OTC) sur les march\u00e9s de l&#039;UE et des \u00c9tats-Unis.<\/p>\n<p>En effet, \u00e0 mesure que les chercheurs recueillent des preuves concr\u00e8tes, ils peuvent examiner des variables jusque-l\u00e0 non prises en compte dans les premi\u00e8res phases des essais, telles que le tabagisme et la consommation d\u2019alcool, ce qui leur permet de mieux comprendre comment ces facteurs impactent le produit de l\u2019\u00e9tude.<\/p>\n<p>Le client, reconnaissant l&#039;\u00e9mergence de lignes directrices sur l&#039;utilisation appropri\u00e9e des preuves du monde r\u00e9el pour \u00e9tayer les all\u00e9gations sur les deux march\u00e9s, souhaitait garantir son adh\u00e9sion \u00e0 la nouvelle r\u00e9glementation lors de l&#039;utilisation des preuves pour \u00e9tayer les all\u00e9gations de son produit.<\/p>\n<p>&nbsp;<\/p>\n<h2 class=\"h4\">Qu&#039;est-ce que le <strong>Probl\u00e8me<\/strong>?<\/h2>\n<p>Le client avait besoin d&#039;obtenir un aper\u00e7u des r\u00e9glementations relatives \u00e0 l&#039;utilisation de preuves du monde r\u00e9el<\/p>\n<ul>\n<li>\u00c9valuer la faisabilit\u00e9 et les exigences en mati\u00e8re de justification de revendications particuli\u00e8res<\/li>\n<li>Pour favoriser une meilleure compr\u00e9hension des exigences pertinentes<\/li>\n<li>Et adh\u00e9rer aux nouvelles directives r\u00e9glementaires sur l&#039;utilisation de preuves du monde r\u00e9el pour \u00e9tayer de nouvelles all\u00e9gations ou renforcer les indications existantes<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<h2 class=\"h4\">Ce que nous <strong>A fait<\/strong>\u2026<\/h2>\n<p>RegASK a propos\u00e9 une solution de r\u00e9ponse rapide en s&#039;appuyant sur son r\u00e9seau mondial d&#039;experts en r\u00e9glementation et sa technologie automatis\u00e9e exclusive, et<\/p>\n<ul>\n<li>Exigences identifi\u00e9es sur les march\u00e9s de l&#039;UE et des \u00c9tats-Unis<\/li>\n<li>\u00c9valuer les affirmations souhait\u00e9es pour estimer la probabilit\u00e9 de justification par des preuves concr\u00e8tes<\/li>\n<li>Et a recommand\u00e9 une strat\u00e9gie avant-gardiste pour chaque march\u00e9<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<h2 class=\"h4\">Comment \u00e7a s&#039;est pass\u00e9 <strong>Faire<\/strong>?<\/h2>\n<p>RegASK a fourni un aper\u00e7u r\u00e9glementaire clair de la justification des revendications dans le monde r\u00e9el en moins de trois semaines.<\/p>\n<p>Le client a pu prendre des d\u00e9cisions appropri\u00e9es et efficaces gr\u00e2ce \u00e0 la justification de sa r\u00e9clamation et\u00a0<strong>d\u00e9finir une strat\u00e9gie d\u2019essais cliniques solide sur les march\u00e9s de l\u2019UE et des \u00c9tats-Unis.<\/strong><\/p>\n<p>&nbsp;<\/p>\n<h2 class=\"h4\"><strong>Conclusion<\/strong><\/h2>\n<p>Notre client avait besoin d&#039;aide pour\u00a0<a href=\"https:\/\/regask.com\/fr\/our-solution\/\"><strong>justifier l&#039;un de ses produits en vente libre par des preuves concr\u00e8tes<\/strong><\/a>\u00a0et le\u00a0<strong>validation d&#039;une strat\u00e9gie d&#039;essai clinique<\/strong>.<\/p>\n<p>Les efforts de nos experts en r\u00e9glementation, combin\u00e9s \u00e0 notre technologie automatis\u00e9e exclusive, nous ont permis de les d\u00e9livrer en moins de trois semaines.\u00a0<strong>toutes les informations r\u00e9glementaires sur la justification des revendications par des preuves concr\u00e8tes\u00a0<\/strong>ils devaient d\u00e9cider comment aborder le choix d\u2019une strat\u00e9gie clinique solide.<\/p>\n<a data-animate=\"fadeInUp\" href=\"https:\/\/regask.com\/fr\/contact-2\/\" target=\"_blank\" class=\"button secondary\" rel=\"noopener\" >\n\t\t<span>Demander un devis<\/span>\n\t<\/a>","protected":false},"excerpt":{"rendered":"<p>A leader in the pharmaceutical industry wanted to leverage real-world evidence to bolster the claims of an over the counter (OTC) product in the E.U. and U.S. markets. Indeed, as researchers collect real-world evidence, they can examine variables previously unaccounted for in early trial phases such as smoking and drinking, allowing them to gain a&#8230;<\/p>","protected":false},"author":39,"featured_media":1813,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[17,21],"tags":[],"class_list":["post-1225","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-case-study","category-pharma-and-biotech"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.8 (Yoast SEO v27.9) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Real-World Evidence for OTC Claims | RegASK<\/title>\n<meta name=\"description\" content=\"Learn how real-world evidence supports claim substantiation for OTC products in Europe and the USA with RegASK.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/regask.com\/fr\/preuves-du-monde-reel-allegations-de-gre-a-gre\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"How Real-World Evidence Supported Claim Substantiation on OTC Product in Europe and the USA\" \/>\n<meta property=\"og:description\" content=\"Learn how real-world evidence supports claim substantiation for OTC products in Europe and the USA with RegASK.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/regask.com\/fr\/preuves-du-monde-reel-allegations-de-gre-a-gre\/\" \/>\n<meta property=\"og:site_name\" content=\"RegASK\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/RegASKRegulatoryAffairs\/\" \/>\n<meta property=\"article:published_time\" content=\"2022-03-15T09:09:37+00:00\" \/>\n<meta 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