{"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":"%e7%8f%be%e5%ae%9f%e4%b8%96%e7%95%8c%e3%81%ae%e8%a8%bc%e6%8b%a0-otc-%e3%82%af%e3%83%ac%e3%83%bc%e3%83%a0","status":"publish","type":"post","link":"https:\/\/regask.com\/ja\/real-world-evidence-otc-claims\/","title":{"rendered":"\u73fe\u5b9f\u4e16\u754c\u306e\u8a3c\u62e0\u304c\u4e3b\u5f35\u306e\u5b9f\u8a3c\u3092\u3069\u306e\u3088\u3046\u306b\u30b5\u30dd\u30fc\u30c8\u3057\u305f\u304b\u2026"},"content":{"rendered":"<p>\u88fd\u85ac\u696d\u754c\u306e\u30ea\u30fc\u30c0\u30fc\u4f01\u696d\u306f\u3001EU \u304a\u3088\u3073\u7c73\u56fd\u5e02\u5834\u3067\u5e02\u8ca9 (OTC) \u88fd\u54c1\u306e\u52b9\u80fd\u3092\u5f37\u5316\u3059\u308b\u305f\u3081\u306b\u3001\u30ea\u30a2\u30eb\u30ef\u30fc\u30eb\u30c9 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<strong>\u3059\u308b<\/strong>?<\/h2>\n<p>RegASK \u306f\u30013 \u9031\u9593\u4ee5\u5185\u306b\u5b9f\u969b\u306e\u30af\u30ec\u30fc\u30e0\u306e\u5b9f\u8a3c\u306b\u95a2\u3059\u308b\u660e\u78ba\u306a\u898f\u5236\u6982\u8981\u3092\u63d0\u4f9b\u3057\u307e\u3057\u305f\u3002<\/p>\n<p>\u30af\u30e9\u30a4\u30a2\u30f3\u30c8\u306f\u3001\u8acb\u6c42\u306e\u6839\u62e0\u306b\u57fa\u3065\u3044\u3066\u9069\u5207\u304b\u3064\u52b9\u7387\u7684\u306a\u6c7a\u5b9a\u3092\u4e0b\u3059\u3053\u3068\u304c\u3067\u304d\u3001\u00a0<strong>EU \u304a\u3088\u3073\u7c73\u56fd\u5e02\u5834\u306b\u304a\u3051\u308b\u5065\u5168\u306a\u81e8\u5e8a\u8a66\u9a13\u6226\u7565\u3092\u7279\u5b9a\u3057\u307e\u3059\u3002<\/strong><\/p>\n<p>&nbsp;<\/p>\n<h2 class=\"h4\"><strong>\u7d50\u8ad6<\/strong><\/h2>\n<p>\u79c1\u305f\u3061\u306e\u30af\u30e9\u30a4\u30a2\u30f3\u30c8\u306f\u3001\u00a0<a href=\"https:\/\/regask.com\/ja\/our-solution\/\"><strong>\u5b9f\u4e16\u754c\u306e\u8a3c\u62e0\u3092\u901a\u3058\u3066OTC\u88fd\u54c1\u306e1\u3064\u3092\u5b9f\u8a3c\u3059\u308b<\/strong><\/a>\u00a0\u305d\u3057\u3066\u00a0<strong>\u81e8\u5e8a\u8a66\u9a13\u6226\u7565\u306e\u691c\u8a3c<\/strong>.<\/p>\n<p>\u5f53\u793e\u306e\u898f\u5236\u5c02\u9580\u5bb6\u306e\u52aa\u529b\u3068\u72ec\u81ea\u306e\u81ea\u52d5\u5316\u6280\u8853\u3092\u7d44\u307f\u5408\u308f\u305b\u308b\u3053\u3068\u3067\u30013\u9031\u9593\u4ee5\u5185\u306b\u00a0<strong>\u73fe\u5b9f\u4e16\u754c\u306e\u8a3c\u62e0\u306b\u3088\u308b\u4e3b\u5f35\u306e\u7acb\u8a3c\u306b\u95a2\u3059\u308b\u3059\u3079\u3066\u306e\u898f\u5236\u4e0a\u306e\u6d1e\u5bdf\u00a0<\/strong>\u5f7c\u3089\u306f\u3001\u5805\u5b9f\u306a\u81e8\u5e8a\u6226\u7565\u3092\u9078\u629e\u3059\u308b\u305f\u3081\u306b\u3069\u306e\u3088\u3046\u306a\u30a2\u30d7\u30ed\u30fc\u30c1\u3092\u53d6\u308b\u304b\u3092\u6c7a\u5b9a\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3057\u305f\u3002<\/p>\n<a data-animate=\"fadeInUp\" href=\"https:\/\/regask.com\/ja\/%e6%8e%a5%e8%a7%a6\/\" target=\"_blank\" class=\"button secondary\" rel=\"noopener\" >\n\t\t<span>\u898b\u7a4d\u3082\u308a\u3092\u4f9d\u983c\u3059\u308b<\/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 deeper understanding of how such factors impact the study product. The client, recognizing the emergence of guidelines on the proper use of real-world evidence for claims support in both markets, wanted to ensure their adherence to new regulation when using the evidence to substantiate their product\u2019s claims. &nbsp; What&#8217;s The Problem? The client needed to&#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 v27.6 (Yoast SEO v27.6) - 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\/ja\/\u73fe\u5b9f\u4e16\u754c\u306e\u8a3c\u62e0-otc-\u30af\u30ec\u30fc\u30e0\/\" \/>\n<meta property=\"og:locale\" content=\"ja_JP\" \/>\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\/ja\/\u73fe\u5b9f\u4e16\u754c\u306e\u8a3c\u62e0-otc-\u30af\u30ec\u30fc\u30e0\/\" \/>\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 property=\"article:modified_time\" content=\"2024-11-21T21:29:31+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/regask.com\/wp-content\/uploads\/2020\/11\/POST-How-Real-World-Evidence-Supported-Claim-Substantiation-On-OTC-Product-In-Europe-And-USA.png\" \/>\n\t<meta property=\"og:image:width\" content=\"689\" \/>\n\t<meta property=\"og:image:height\" content=\"626\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"Benoit Trouwaert\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:creator\" content=\"@ASKRegASK\" \/>\n<meta name=\"twitter:site\" content=\"@ASKRegASK\" \/>\n<meta name=\"twitter:label1\" content=\"\u57f7\u7b46\u8005\" \/>\n\t<meta name=\"twitter:data1\" content=\"Benoit Trouwaert\" \/>\n\t<meta name=\"twitter:label2\" content=\"\u63a8\u5b9a\u8aad\u307f\u53d6\u308a\u6642\u9593\" \/>\n\t<meta name=\"twitter:data2\" content=\"2\u5206\" \/>\n<script type=\"application\/ld+json\" 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