{"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":"beweise-aus-der-praxis-fur-rezeptfreie-behauptungen","status":"publish","type":"post","link":"https:\/\/regask.com\/de\/real-world-evidence-otc-claims\/","title":{"rendered":"Wie Beweise aus der Praxis die Untermauerung von Behauptungen unterst\u00fctzten \u2026"},"content":{"rendered":"<p>Ein f\u00fchrendes Unternehmen der Pharmabranche wollte die Werbeaussagen zu einem rezeptfreien Produkt (OTC) auf dem EU- und US-Markt mithilfe von Praxisbeweisen untermauern.<\/p>\n<p>Tats\u00e4chlich k\u00f6nnen Forscher beim Sammeln realer Beweise Variablen untersuchen, die in fr\u00fchen Versuchsphasen bisher nicht ber\u00fccksichtigt wurden, wie etwa Rauchen und Trinken. Dadurch k\u00f6nnen sie ein tieferes Verst\u00e4ndnis davon gewinnen, wie sich diese Faktoren auf das Studienprodukt auswirken.<\/p>\n<p>Der Kunde war sich der Entstehung von Richtlinien zur ordnungsgem\u00e4\u00dfen Verwendung von Beweismitteln aus der Praxis zur Untermauerung von Produktanspr\u00fcchen in beiden M\u00e4rkten bewusst und wollte sicherstellen, dass er bei der Verwendung der Beweise zur Untermauerung der Produktanspr\u00fcche die neuen Vorschriften einh\u00e4lt.<\/p>\n<p>&nbsp;<\/p>\n<h2 class=\"h4\">Was ist das <strong>Problem<\/strong>?<\/h2>\n<p>Der Kunde ben\u00f6tigte einen \u00dcberblick \u00fcber die Vorschriften zur Verwendung von Real-World-Evidence<\/p>\n<ul>\n<li>Um die Machbarkeit und Anforderungen f\u00fcr die Begr\u00fcndung bestimmter Anspr\u00fcche zu bewerten<\/li>\n<li>F\u00f6rderung eines besseren Verst\u00e4ndnisses der relevanten Anforderungen<\/li>\n<li>Und halten Sie sich an neue regulatorische Richtlinien zur Verwendung von Real-World-Evidenz, um neue Behauptungen zu untermauern oder bestehende Indikationen zu st\u00e4rken<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<h2 class=\"h4\">Was wir <strong>Tat<\/strong>\u2026<\/h2>\n<p>RegASK schlug eine schnelle L\u00f6sung vor, indem es sein globales Netzwerk von Regulierungsexperten und seine propriet\u00e4re automatisierte Technologie nutzte, und<\/p>\n<ul>\n<li>Identifizierte Anforderungen auf den EU- und US-M\u00e4rkten<\/li>\n<li>Bewertete die gew\u00fcnschten Anspr\u00fcche, um die Wahrscheinlichkeit einer Untermauerung durch reale Beweise abzusch\u00e4tzen<\/li>\n<li>Und empfahl eine vorausschauende Strategie f\u00fcr jeden Markt<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<h2 class=\"h4\">Wie ist es <strong>Tun<\/strong>?<\/h2>\n<p>RegASK lieferte in weniger als drei Wochen einen klaren regulatorischen \u00dcberblick \u00fcber die Begr\u00fcndung realer Anspr\u00fcche.<\/p>\n<p>Der Kunde konnte mit der Begr\u00fcndung seiner Anspr\u00fcche angemessene und effiziente Entscheidungen treffen und\u00a0<strong>Entwickeln Sie eine solide Strategie f\u00fcr klinische Studien auf dem EU- und US-Markt.<\/strong><\/p>\n<p>&nbsp;<\/p>\n<h2 class=\"h4\"><strong>Abschluss<\/strong><\/h2>\n<p>Unser Kunde ben\u00f6tigte Hilfe bei der\u00a0<a href=\"https:\/\/regask.com\/de\/our-solution\/\"><strong>Anspruchsbegr\u00fcndung f\u00fcr eines seiner OTC-Produkte durch reale Beweise<\/strong><\/a>\u00a0und die\u00a0<strong>Validierung einer klinischen Studienstrategie<\/strong>.<\/p>\n<p>Dank der Bem\u00fchungen unserer Regulierungsexperten und unserer propriet\u00e4ren automatisierten Technologie konnten wir ihnen in weniger als drei Wochen\u00a0<strong>alle regulatorischen Erkenntnisse zur Untermauerung von Anspr\u00fcchen mit realen Beweisen\u00a0<\/strong>Sie mussten entscheiden, wie sie bei der Auswahl einer soliden klinischen Strategie vorgehen wollten.<\/p>\n<a data-animate=\"fadeInUp\" href=\"https:\/\/regask.com\/de\/kontakt\/\" target=\"_blank\" class=\"button secondary\" rel=\"noopener\" >\n\t\t<span>Angebot anfordern<\/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 v27.2 (Yoast SEO v27.3) - 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\" 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