{"id":9458,"date":"2021-08-20T12:28:31","date_gmt":"2021-08-20T12:28:31","guid":{"rendered":"https:\/\/www.kolabtree.com\/blog\/?p=9458"},"modified":"2023-03-10T09:43:35","modified_gmt":"2023-03-10T09:43:35","slug":"medical-device-risk-management-rmp-template-free","status":"publish","type":"post","link":"https:\/\/www.kolabtree.com\/blog\/ja\/medical-device-risk-management-rmp-template-free\/","title":{"rendered":"\u533b\u7642\u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30d7\u30e9\u30f3\uff08RMP\uff09\u30c6\u30f3\u30d7\u30ec\u30fc\u30c8\uff08\u7121\u6599"},"content":{"rendered":"<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_45_1 counter-flat ez-toc-counter ez-toc-grey ez-toc-container-direction\">\n<div class=\"ez-toc-title-container\">\n<p class=\"ez-toc-title\">table of contents<\/p>\n<span class=\"ez-toc-title-toggle\"><a href=\"#\" class=\"ez-toc-pull-right ez-toc-btn ez-toc-btn-xs ez-toc-btn-default ez-toc-toggle\" area-label=\"ez-toc-toggle-icon-1\"><label 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id=\"item-69f2f532bdf9a\"><\/a><\/span><\/div>\n<nav><ul class='ez-toc-list ez-toc-list-level-1' ><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/medical-device-risk-management-rmp-template-free\/#What_is_a_Risk_Management_Plan_RMP\" title=\"\u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30d7\u30e9\u30f3\uff08RMP\uff09\u3068\u306f\uff1f\">\u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30d7\u30e9\u30f3\uff08RMP\uff09\u3068\u306f\uff1f<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/medical-device-risk-management-rmp-template-free\/#Why_do_you_need_an_RMP_template\" title=\"\u306a\u305cRMP\u30c6\u30f3\u30d7\u30ec\u30fc\u30c8\u304c\u5fc5\u8981\u306a\u306e\u304b\uff1f\">\u306a\u305cRMP\u30c6\u30f3\u30d7\u30ec\u30fc\u30c8\u304c\u5fc5\u8981\u306a\u306e\u304b\uff1f<\/a><\/li><\/ul><\/nav><\/div>\n<p><em><a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/nare-simonyan\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=RMPfreetemplate\">Nare Simonyan<\/a>\u306f\u3001Kolabtree\u306e\u85ac\u4e8b\u304a\u3088\u3073\u81e8\u5e8a\u8a66\u9a13\u306e\u5c02\u9580\u5bb6\u3067\u3042\u308b\u3002 <a href=\"https:\/\/www.kolabtree.com\/blog\/what-is-regulatory-dossier-and-what-does-it-contain\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=RMPfreetemplate\">\u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30d7\u30e9\u30f3<\/a> (RMP)\u30c6\u30f3\u30d7\u30ec\u30fc\u30c8\u306f\u3001\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u3084\u88fd\u85ac\u4f1a\u793e\u304c\u88fd\u54c1\u63d0\u51fa\u306e\u969b\u306b\u53c2\u8003\u306b\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002<\/em><\/p>\n<h2><span class=\"ez-toc-section\" id=\"What_is_a_Risk_Management_Plan_RMP\"><\/span>\u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30d7\u30e9\u30f3\uff08RMP\uff09\u3068\u306f\uff1f<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30d7\u30e9\u30f3\uff08RMP\uff09\u306f\u3001\u533b\u85ac\u54c1\u306e\u5b89\u5168\u6027\u306e\u7279\u5fb4\u3001\u7279\u306b\u60a3\u8005\u306e\u30ea\u30b9\u30af\u306e\u91cd\u75c7\u5ea6\u3092\u8efd\u6e1b\u3059\u308b\u305f\u3081\u306e\u4e0d\u6e2c\u306e\u4e8b\u614b\u3092\u8a73\u7d30\u306b\u8aac\u660e\u3059\u308b\u6587\u66f8\u3067\u3059\u3002\u307e\u305f\u3001RMP\u306e\u30c6\u30f3\u30d7\u30ec\u30fc\u30c8\u6587\u66f8\u3067\u306f\u3001\u30ea\u30b9\u30af\u3092\u6700\u5c0f\u5316\u307e\u305f\u306f\u9632\u6b62\u3057\u3001\u533b\u85ac\u54c1\u306e\u5b89\u5168\u6027\u3092\u5411\u4e0a\u3055\u305b\u308b\u305f\u3081\u306e\u7d99\u7d9a\u7684\u306a\u7814\u7a76\u306b\u3001\u4f01\u696d\u304c\u3069\u306e\u3088\u3046\u306b\u95a2\u4e0e\u3059\u308b\u304b\u3092\u8a73\u3057\u304f\u8aac\u660e\u3059\u308b\u3053\u3068\u304c\u6c42\u3081\u3089\u308c\u307e\u3059\u3002<\/p>\n<h2><span class=\"ez-toc-section\" id=\"Why_do_you_need_an_RMP_template\"><\/span>\u306a\u305cRMP\u30c6\u30f3\u30d7\u30ec\u30fc\u30c8\u304c\u5fc5\u8981\u306a\u306e\u304b\uff1f<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\u4f01\u696d\u306f\u3001\u5e02\u8ca9\u627f\u8a8d\u3092\u7533\u8acb\u3059\u308b\u969b\u306b\u3001\u6b27\u5dde\u533b\u85ac\u54c1\u5e81\uff08EMA\uff09\u306a\u3069\u306e\u7ba1\u8f44\u533b\u7642\u6a5f\u95a2\u306b\u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30d7\u30e9\u30f3\u3092\u63d0\u51fa\u3059\u308b\u3053\u3068\u304c\u6c42\u3081\u3089\u308c\u307e\u3059\u3002\u307e\u305f\u3001\u56fd\u5185\u3067\u627f\u8a8d\u3055\u308c\u305f\u533b\u7642\u88fd\u54c1\u306b\u3064\u3044\u3066\u306f\u3001\u56fd\u5185\u4e3b\u7ba1\u5e81\uff08NCA\uff09\u304cRMP\u3092\u8981\u6c42\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002<\/p>\n<p>\u3053\u306e\u7121\u6599\u306eRMP\u30c6\u30f3\u30d7\u30ec\u30fc\u30c8\u306f\u3001\u65b0\u88fd\u54c1\u306e\u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30d7\u30e9\u30f3\u3092\u63d0\u51fa\u3059\u308b\u5fc5\u8981\u304c\u3042\u308b\u3068\u304d\u306b\u3001\u53c2\u8003\u306b\u306a\u308a\u307e\u3059\u3002<\/p>\n<div class=\"forminator-ui forminator-custom-form forminator-custom-form-10527 forminator-design--flat  forminator_ajax\" data-forminator-render=\"0\" data-form=\"forminator-module-10527\" data-uid=\"69f2f5328b064\"><br\/><\/div><form\n\t\t\t\tid=\"forminator-module-10527\"\n\t\t\t\tclass=\"forminator-ui forminator-custom-form forminator-custom-form-10527 forminator-design--flat  forminator_ajax\"\n\t\t\t\tmethod=\"post\"\n\t\t\t\tdata-forminator-render=\"0\"\n\t\t\t\tdata-form-id=\"10527\"\n\t\t\t\t\n\t\t\t\tdata-design=\"flat\"\n\t\t\t\t\n\t\t\t\t\n\t\t\t\t\n\t\t\t\tdata-grid=\"open\"\n\t\t\t\t\n\t\t\t\t\n\t\t\t\tstyle=\"display: none;\"\n\t\t\t\t\n\t\t\t\tdata-uid=\"69f2f5328b064\" action=\"\"\n\t\t\t><div class=\"forminator-response-message forminator-error\" aria-hidden=\"true\"><\/div><div class=\"forminator-row\"><div id=\"email-1\" class=\"forminator-col forminator-col-12\"><div class=\"forminator-field\"><label for=\"forminator-field-email-1_69f2f5328b064\" class=\"forminator-label\">\u30e1\u30fc\u30eb\u30a2\u30c9\u30ec\u30b9 <span class=\"forminator-required\">*<\/span><\/label><input type=\"email\" name=\"email-1\" value=\"\" placeholder=\"\" id=\"forminator-field-email-1_69f2f5328b064\" class=\"forminator-input forminator-email--field\" data-required=\"1\" aria-required=\"true\" \/><\/div><\/div><\/div><input type=\"hidden\" name=\"referer_url\" value=\"\" \/><div class=\"forminator-row forminator-row-last\"><div class=\"forminator-col\"><div class=\"forminator-field\"><button class=\"forminator-button forminator-button-submit\">Download the Free Template Here.<\/button><\/div><\/div><\/div><input type=\"hidden\" id=\"forminator_nonce\" name=\"forminator_nonce\" value=\"74690d92fd\" \/><input type=\"hidden\" name=\"_wp_http_referer\" value=\"\/blog\/ja\/wp-json\/wp\/v2\/posts\/9458\" \/><input type=\"hidden\" name=\"form_id\" value=\"10527\"><input type=\"hidden\" name=\"page_id\" value=\"9458\"><input type=\"hidden\" name=\"form_type\" value=\"default\"><input type=\"hidden\" name=\"current_url\" value=\"https:\/\/www.kolabtree.com\/blog\/ja\/medical-device-risk-management-rmp-template-free\/\"><input type=\"hidden\" name=\"render_id\" value=\"0\"><input type=\"hidden\" name=\"action\" value=\"forminator_submit_form_custom-forms\"><input type=\"hidden\" name=\"trp-form-language\" value=\"ja\"\/><\/form><p>\u3053\u306eRMP\u30c6\u30f3\u30d7\u30ec\u30fc\u30c8\u306f\u3001Kolabtree\u306e\u30d5\u30ea\u30fc\u30e9\u30f3\u30b5\u30fc\u3067\u3042\u308bNare Simonyan\u306b\u3088\u3063\u3066\u4f5c\u6210\u3055\u308c\u307e\u3057\u305f\u3002 <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/regulatory-affairs?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=RMPfreetemplate\">\u30d5\u30ea\u30fc\u30e9\u30f3\u30b9\u30fb\u30ec\u30ae\u30e5\u30e9\u30c8\u30ea\u30fc\u30fb\u30b3\u30f3\u30b5\u30eb\u30bf\u30f3\u30c8<\/a> \u88fd\u85ac\u79d1\u5b66\u3067\u535a\u58eb\u53f7\u3092\u53d6\u5f97\u3002\u81e8\u5e8a\u8a66\u9a13\u3001\u30ec\u30ae\u30e5\u30e9\u30c8\u30ea\u30fc\u30fb\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u3001\u30b5\u30a4\u30a8\u30f3\u30c6\u30a3\u30d5\u30a3\u30c3\u30af\u30fb\u30e9\u30a4\u30c6\u30a3\u30f3\u30b0\u3001\u30e1\u30c7\u30a3\u30ab\u30eb\u30fb\u30ec\u30d3\u30e5\u30fc\u306a\u3069\u3001\u3055\u307e\u3056\u307e\u306a\u30c6\u30fc\u30de\u3067\u30b3\u30f3\u30b5\u30eb\u30c6\u30a3\u30f3\u30b0\u3092\u884c\u3063\u3066\u3044\u308b\u3002Nare\u306b\u76f4\u63a5\u9023\u7d61\u3059\u308b <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/nare-simonyan?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=RMPfreetemplate\">\u3092\u3054\u89a7\u304f\u3060\u3055\u3044\u3002<\/a><\/p>\n<p><a href=\"https:\/\/www.kolabtree.com\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=RMPfreetemplate\">\u30b3\u30e9\u30d6\u30c4\u30ea\u30fc<\/a> \u306f\u3001\u79d1\u5b66\u8005\u3084\u696d\u754c\u306e\u5c02\u9580\u5bb6\u306e\u30b0\u30ed\u30fc\u30d0\u30eb\u30cd\u30c3\u30c8\u30ef\u30fc\u30af\u306b\u76f4\u63a5\u30a2\u30af\u30bb\u30b9\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002\u79c1\u305f\u3061\u306e\u5c02\u9580\u5bb6\u306f\u3001\u5e45\u5e83\u3044\u30cb\u30c3\u30c1\u306a\u9818\u57df\u3067\u30d5\u30ea\u30fc\u30e9\u30f3\u30b9\u306e\u30b5\u30fc\u30d3\u30b9\u3092\u63d0\u4f9b\u3057\u3066\u3044\u307e\u3059\u3002\u5c02\u9580\u5bb6\u306e\u63a1\u7528\u3092\u304a\u8003\u3048\u3067\u3059\u304b\uff1f<a href=\"https:\/\/www.kolabtree.com\/create-project?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=RMPfreetemplate\"> \u7121\u6599\u3067\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u3092\u6295\u7a3f\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002<\/a>\u3092\u3054\u89a7\u306b\u306a\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002<a href=\"https:\/\/www.kolabtree.com\/find-an-expert?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=RMPfreetemplate\"> \u30c8\u30c3\u30d7\u30ec\u30fc\u30c8\u306e\u30d5\u30ea\u30fc\u30e9\u30f3\u30b5\u30fc<\/a>.<\/p>","protected":false},"excerpt":{"rendered":"<p>Nare Simonyan, regulatory affairs and clinical trials specialist on Kolabtree, provides a Risk Management Plan (RMP) template that medical devices and pharma companies can use as a reference point for their product submissions. What is a Risk Management Plan (RMP)? A Risk Management Plan or RMP is a document that details the medicinal product&#8217;s safety features, particularly the contingencies in place to reduce its risk severity amongst patients. The RMP template document also requires companies to elaborate on how they will be involved in on-going studies to minimize or prevent risks and enhance the safety of the medicine. Why do you need an RMP template? Companies are required to submit<\/p>\n<div class=\"read-more\"><a href=\"https:\/\/www.kolabtree.com\/blog\/ja\/medical-device-risk-management-rmp-template-free\/\" title=\"\u7d9a\u304d\u3092\u8aad\u3080\">\u7d9a\u304d\u3092\u8aad\u3080<\/a><\/div>","protected":false},"author":605,"featured_media":9463,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[442,317,247,443,540,653,516],"tags":[45,59,21,38],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v20.1 (Yoast SEO v20.1) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Medical Risk Management Plan (RMP) Template (FREE) -<\/title>\n<meta name=\"description\" content=\"Looking to draft a risk management plan? Here&#039;s a free reference RMP template drafted by our regulatory expert that you can use.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/medical-device-risk-management-rmp-template-free\/\" \/>\n<meta property=\"og:locale\" content=\"ja_JP\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Medical Risk Management Plan (RMP) Template (FREE)\" \/>\n<meta property=\"og:description\" content=\"Looking to draft a risk management plan? Here&#039;s a free reference RMP template drafted by our regulatory expert that you can use.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.kolabtree.com\/blog\/ja\/medical-device-risk-management-rmp-template-free\/\" \/>\n<meta property=\"og:site_name\" content=\"The Kolabtree Blog\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/kolabtree\" \/>\n<meta property=\"article:published_time\" content=\"2021-08-20T12:28:31+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2023-03-10T09:43:35+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2021\/08\/RMP-Template.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"1920\" \/>\n\t<meta property=\"og:image:height\" content=\"1080\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"Naren Madan\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:creator\" content=\"@kolabtree\" \/>\n<meta name=\"twitter:site\" content=\"@kolabtree\" \/>\n<meta name=\"twitter:label1\" content=\"\u57f7\u7b46\u8005\" \/>\n\t<meta name=\"twitter:data1\" content=\"Naren Madan\" \/>\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<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"Medical Risk Management Plan (RMP) Template (FREE) -","description":"Looking to draft a risk management plan? 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