{"id":9226,"date":"2021-07-28T16:37:47","date_gmt":"2021-07-28T16:37:47","guid":{"rendered":"https:\/\/www.kolabtree.com\/blog\/?p=9226"},"modified":"2023-02-15T11:44:54","modified_gmt":"2023-02-15T11:44:54","slug":"how-to-prepare-a-risk-management-plan-rmp-an-essential-guide","status":"publish","type":"post","link":"https:\/\/www.kolabtree.com\/blog\/ja\/how-to-prepare-a-risk-management-plan-rmp-an-essential-guide\/","title":{"rendered":"\u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30d7\u30e9\u30f3\uff08RMP\uff09\u3092\u4f5c\u6210\u3059\u308b\u65b9\u6cd5\u3002\u30a8\u30c3\u30bb\u30f3\u30b7\u30e3\u30eb\u30fb\u30ac\u30a4\u30c9"},"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 for=\"item-69f32f0706f59\" aria-label=\"Table of Content\"><span style=\"display: flex;align-items: center;width: 35px;height: 30px;justify-content: center;direction:ltr;\"><svg style=\"fill: #999;color:#999\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewbox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #999;color:#999\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewbox=\"0 0 24 24\" version=\"1.2\" baseprofile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/label><input  type=\"checkbox\" id=\"item-69f32f0706f59\"><\/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\/how-to-prepare-a-risk-management-plan-rmp-an-essential-guide\/#Abbreviations\" title=\"\u7565\u8a9e\u306b\u3064\u3044\u3066\">\u7565\u8a9e\u306b\u3064\u3044\u3066<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/how-to-prepare-a-risk-management-plan-rmp-an-essential-guide\/#Purpose_Scope_of_a_Risk_Management_Plan\" title=\"\u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30d7\u30e9\u30f3\u306e\u76ee\u7684\u3068\u7bc4\u56f2\">\u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30d7\u30e9\u30f3\u306e\u76ee\u7684\u3068\u7bc4\u56f2<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/how-to-prepare-a-risk-management-plan-rmp-an-essential-guide\/#Requirements_of_an_RMP\" title=\"RMP\u306e\u8981\u4ef6\">RMP\u306e\u8981\u4ef6\n<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/how-to-prepare-a-risk-management-plan-rmp-an-essential-guide\/#European_Risk_Management_Plan_Model\" title=\"\u6b27\u5dde\u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30d7\u30e9\u30f3\u30e2\u30c7\u30eb\">\u6b27\u5dde\u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30d7\u30e9\u30f3\u30e2\u30c7\u30eb<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/how-to-prepare-a-risk-management-plan-rmp-an-essential-guide\/#List_for_writing_or_evaluating_an_RMP\" title=\"RMP\u3092\u4f5c\u6210\u307e\u305f\u306f\u8a55\u4fa1\u3059\u308b\u305f\u3081\u306e\u30ea\u30b9\u30c8\">RMP\u3092\u4f5c\u6210\u307e\u305f\u306f\u8a55\u4fa1\u3059\u308b\u305f\u3081\u306e\u30ea\u30b9\u30c8<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/how-to-prepare-a-risk-management-plan-rmp-an-essential-guide\/#Plan_of_Pharmacovigilance\" title=\"\u30d5\u30a1\u30fc\u30de\u30b3\u30d3\u30b8\u30e9\u30f3\u30b9\u306e\u8a08\u753b\">\u30d5\u30a1\u30fc\u30de\u30b3\u30d3\u30b8\u30e9\u30f3\u30b9\u306e\u8a08\u753b<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-7\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/how-to-prepare-a-risk-management-plan-rmp-an-essential-guide\/#Post-authorization_efficacy_studies_plan\" title=\"\u627f\u8a8d\u5f8c\u306e\u6709\u52b9\u6027\u8a66\u9a13\u8a08\u753b\">\u627f\u8a8d\u5f8c\u306e\u6709\u52b9\u6027\u8a66\u9a13\u8a08\u753b<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-8\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/how-to-prepare-a-risk-management-plan-rmp-an-essential-guide\/#Risk_mitigation_plan\" title=\"\u30ea\u30b9\u30af\u8efd\u6e1b\u8a08\u753b\">\u30ea\u30b9\u30af\u8efd\u6e1b\u8a08\u753b<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-9\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/how-to-prepare-a-risk-management-plan-rmp-an-essential-guide\/#Summary_for_Risk_management_plan\" title=\"\u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30d7\u30e9\u30f3\u306e\u6982\u8981\">\u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30d7\u30e9\u30f3\u306e\u6982\u8981<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-10\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/how-to-prepare-a-risk-management-plan-rmp-an-essential-guide\/#United_State_FDA_General_quality_Risk_Management_Process\" title=\"\u7c73\u56fd(FDA)\u4e00\u822c\u54c1\u8cea\u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30d7\u30ed\u30bb\u30b9\">\u7c73\u56fd(FDA)\u4e00\u822c\u54c1\u8cea\u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30d7\u30ed\u30bb\u30b9<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-11\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/how-to-prepare-a-risk-management-plan-rmp-an-essential-guide\/#Main_Responsibilities\" title=\"\u4e3b\u306a\u62c5\u5f53\u696d\u52d9\">\u4e3b\u306a\u62c5\u5f53\u696d\u52d9<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-12\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/how-to-prepare-a-risk-management-plan-rmp-an-essential-guide\/#Initiating_a_Quality_Risk_Management_Process_QRMP\" title=\"\u54c1\u8cea\u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30d7\u30ed\u30bb\u30b9\uff08QRMP\uff09\u306e\u958b\u59cb\">\u54c1\u8cea\u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30d7\u30ed\u30bb\u30b9\uff08QRMP\uff09\u306e\u958b\u59cb<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-13\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/how-to-prepare-a-risk-management-plan-rmp-an-essential-guide\/#Assessment_for_Risk\" title=\"\u30ea\u30b9\u30af\u306e\u8a55\u4fa1\">\u30ea\u30b9\u30af\u306e\u8a55\u4fa1<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-14\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/how-to-prepare-a-risk-management-plan-rmp-an-essential-guide\/#Control_for_Risk\" title=\"\u30ea\u30b9\u30af\u306b\u5bfe\u3059\u308b\u30b3\u30f3\u30c8\u30ed\u30fc\u30eb\">\u30ea\u30b9\u30af\u306b\u5bfe\u3059\u308b\u30b3\u30f3\u30c8\u30ed\u30fc\u30eb<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-15\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/how-to-prepare-a-risk-management-plan-rmp-an-essential-guide\/#Communication_for_Risk\" title=\"\u30ea\u30b9\u30af\u306b\u5bfe\u3059\u308b\u30b3\u30df\u30e5\u30cb\u30b1\u30fc\u30b7\u30e7\u30f3\">\u30ea\u30b9\u30af\u306b\u5bfe\u3059\u308b\u30b3\u30df\u30e5\u30cb\u30b1\u30fc\u30b7\u30e7\u30f3<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-16\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/how-to-prepare-a-risk-management-plan-rmp-an-essential-guide\/#Review_for_Risk\" title=\"\u30ea\u30b9\u30af\u306b\u5bfe\u3059\u308b\u30ec\u30d3\u30e5\u30fc\">\u30ea\u30b9\u30af\u306b\u5bfe\u3059\u308b\u30ec\u30d3\u30e5\u30fc<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-17\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/how-to-prepare-a-risk-management-plan-rmp-an-essential-guide\/#Management_methodology_of_risk\" title=\"\u30ea\u30b9\u30af\u306e\u7ba1\u7406\u65b9\u6cd5\">\u30ea\u30b9\u30af\u306e\u7ba1\u7406\u65b9\u6cd5<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-18\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/how-to-prepare-a-risk-management-plan-rmp-an-essential-guide\/#Management_methods_and_tools_of_risk\" title=\"\u30ea\u30b9\u30af\u306e\u7ba1\u7406\u65b9\u6cd5\u3068\u30c4\u30fc\u30eb\">\u30ea\u30b9\u30af\u306e\u7ba1\u7406\u65b9\u6cd5\u3068\u30c4\u30fc\u30eb<\/a><\/li><\/ul><\/nav><\/div>\n<p>Nare Simonyan, \u30d5\u30ea\u30fc\u30e9\u30f3\u30b9 <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/nare-simonyan\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=RMP\">\u85ac\u4e8b\u30b9\u30da\u30b7\u30e3\u30ea\u30b9\u30c8<\/a> \u306eKolabtree\u3067\u306f\u3001\u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30d7\u30e9\u30f3\uff08RMP\uff09\u3092\u4f5c\u6210\u3059\u308b\u305f\u3081\u306e\u5305\u62ec\u7684\u306a\u30ac\u30a4\u30c9\u3092\u63d0\u4f9b\u3057\u3066\u3044\u307e\u3059\u3002<\/p>\n<h3><span class=\"ez-toc-section\" id=\"Abbreviations\"><\/span><strong>\u7565\u8a9e\u306b\u3064\u3044\u3066<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<ul>\n<li>RMP - \u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30d7\u30e9\u30f3<\/li>\n<li>aPV - \u8ffd\u52a0\u306e\u30d5\u30a1\u30fc\u30de\u30b3\u30d3\u30b8\u30e9\u30f3\u30b9<\/li>\n<li>eCTD - \u96fb\u5b50\u5316\u3055\u308c\u305f\u5171\u901a\u6280\u8853\u6587\u66f8<\/li>\n<li>PSUR-\u5b9a\u671f\u5b89\u5168\u6027\u5831\u544a\u66f8<\/li>\n<li>PASS - \u8a8d\u53ef\u5f8c\u306e\u5b89\u5168\u6027\u8abf\u67fb<\/li>\n<li>PAES - \u8a8d\u53ef\u53d6\u5f97\u5f8c\u306e\u6709\u52b9\u6027\u8a66\u9a13\u306e\u8a08\u753b<\/li>\n<li>RA-\u898f\u5236\u5f53\u5c40<\/li>\n<li>QRMP - \u54c1\u8cea\u30ea\u30b9\u30af\u7ba1\u7406\u30d7\u30ed\u30bb\u30b9<\/li>\n<li>RMC - \u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u59d4\u54e1\u4f1a<\/li>\n<li>MAA -Marketing Authorization Application<\/li>\n<li>ADR-\u533b\u85ac\u54c1\u526f\u4f5c\u7528<\/li>\n<\/ul>\n<h2><span class=\"ez-toc-section\" id=\"Purpose_Scope_of_a_Risk_Management_Plan\"><\/span><strong>\u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30d7\u30e9\u30f3\u306e\u76ee\u7684\u3068\u7bc4\u56f2<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\u5b89\u5168\u6027\u30d7\u30ed\u30d5\u30a1\u30a4\u30eb\u304c\u78ba\u7acb\u3055\u308c\u305f\u533b\u85ac\u54c1\u306e\u30ea\u30b9\u30af\u3068\u30d5\u30a1\u30fc\u30de\u30b3\u30d3\u30b8\u30e9\u30f3\u30b9\/\u30ea\u30b9\u30af\u6700\u5c0f\u5316\u6d3b\u52d5\u3092\u307e\u3068\u3081\u305f\u6587\u66f8\u3067\u3001\u3042\u308b\u56fd\/\u5730\u57df\u3067\u306e\u7533\u8acb\u3092\u30b5\u30dd\u30fc\u30c8\u3059\u308b\u305f\u3081\u306b\u3088\u304f\u4f7f\u7528\u3055\u308c\u3001\u8981\u7d04\u5f62\u5f0f\u304c\u53d7\u3051\u5165\u308c\u3089\u308c\u308b\u5834\u5408\u306b\u4f7f\u7528\u3055\u308c\u308b\u3002<\/p>\n<p>RMP\u306f\u3001\u793e\u5185\u3067\u627f\u8a8d\u3055\u308c\u305f\u6587\u66f8\u3067\u3042\u308a\u3001\u533b\u85ac\u54c1\u306b\u95a2\u9023\u3059\u308b\u5b89\u5168\u6027\u306e\u61f8\u5ff5\u3092\u7279\u5b9a\u3001\u7279\u5fb4\u3065\u3051\u3001\u307e\u305f\u306f\u8efd\u6e1b\u3059\u308b\u305f\u3081\u306b\u5fc5\u8981\u3068\u8003\u3048\u3089\u308c\u308b\u30ea\u30b9\u30af\u7ba1\u7406\u6d3b\u52d5\uff08\u30ea\u30b9\u30af\u6700\u5c0f\u5316\u5bfe\u7b56\u304a\u3088\u3073\u30d5\u30a1\u30fc\u30de\u30b3\u30d3\u30b8\u30e9\u30f3\u30b9\uff09\u3092\u6587\u66f8\u5316\u3059\u308b\u305f\u3081\u306b\u4f5c\u6210\u3055\u308c\u305f\u3001\u4f01\u696d\u306e\u533b\u5b66\u7684\u898b\u89e3\u3092\u793a\u3059\u3082\u306e\u3067\u3059\u3002\u672c\u6587\u66f8\u306f\u3001\u7279\u5b9a\u306e\u88fd\u54c1\u306b\u95a2\u3059\u308b\u53c2\u7167\u7528\u306e\u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u6587\u66f8\u3068\u3057\u3066\u306e\u5f79\u5272\u3092\u679c\u305f\u3059\u3068\u3068\u3082\u306b\u3001\u4f01\u696d\u306e\u898b\u89e3\u3092\u4e16\u754c\u4e2d\u306e\u9069\u5207\u306a\u30b9\u30c6\u30fc\u30af\u30db\u30eb\u30c0\u30fc\u306b\u4f1d\u3048\u3001\u5404\u56fd\u306e\u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30d7\u30e9\u30f3\uff08RMP\uff09\u306b\u76db\u308a\u8fbc\u3080\u305f\u3081\u306b\u4f7f\u7528\u3055\u308c\u307e\u3059\u3002\u627f\u8a8d\u3055\u308c\u305f\u30b3\u30a2RMP\uff08cRMP\uff09\u304c\u3042\u308b\u5834\u5408\u3001cRMP\u306f\u53c2\u7167RMP\uff08rRMP\uff09\u3068\u3057\u3066\u6a5f\u80fd\u3057\u307e\u3059\u3002<\/p>\n<h2><span class=\"ez-toc-section\" id=\"Requirements_of_an_RMP\"><\/span><strong>RMP\u306e\u8981\u4ef6<br \/>\n<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\u88fd\u54c1\u306eRMP\u306f\u3001\u4ee5\u4e0b\u306e\u3088\u3046\u306b\u3057\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002<\/p>\n<ul>\n<li>\u88fd\u54c1\u306e\u5b89\u5168\u6027\u306b\u95a2\u3059\u308b\u60c5\u5831\u3084\u30c7\u30fc\u30bf\u30bd\u30fc\u30b9\u3068\u306e\u4e00\u8cab\u6027\u304c\u3042\u308b\u3053\u3068<\/li>\n<li>\u306b\u95a2\u3059\u308b\u4f1a\u793e\u306e\u7acb\u5834\u3092\u53cd\u6620\u3055\u305b\u308b\u3002<\/li>\n<\/ul>\n<ol>\n<li>\u533b\u85ac\u54c1\u306e\u30d9\u30cd\u30d5\u30a3\u30c3\u30c8\u3068\u30ea\u30b9\u30af\u306e\u30d0\u30e9\u30f3\u30b9\u306b\u5f71\u97ff\u3092\u4e0e\u3048\u308b\u53ef\u80fd\u6027\u306e\u3042\u308b\u5b89\u5168\u6027\u306e\u61f8\u5ff5\u3092\u542b\u3080\u5b89\u5168\u6027\u30ea\u30b9\u30af\u306e\u7279\u6027\uff08\u3059\u306a\u308f\u3061\u3001\u91cd\u8981\u306a\u30ea\u30b9\u30af <span style=\"font-size: 14px;\">\u3084\u6b20\u843d\u3057\u3066\u3044\u308b\u60c5\u5831\u304c\u3042\u308b\u5834\u5408\u306f\u3001\u8ffd\u52a0\u306e\u30d5\u30a1\u30fc\u30de\u30b3\u30d3\u30b8\u30e9\u30f3\u30b9\uff08aPV\uff09\u304c\u5fc5\u8981\u3068\u306a\u308b\u3002 <\/span><span style=\"font-size: 14px;\">\u6d3b\u52d5\u3001\u307e\u305f\u306f\u975e\u65e5\u5e38\u7684\u306a\u30ea\u30b9\u30af\u6700\u5c0f\u5316\u6d3b\u52d5<\/span><\/li>\n<li>aPV\u6d3b\u52d5\u3084\u975e\u65e5\u5e38\u7684\u306a\u30ea\u30b9\u30af\u6700\u5c0f\u5316\u6d3b\u52d5\u306e\u8a73\u7d30\u3002<\/li>\n<\/ol>\n<ul>\n<li>RMP\u3092\u4f5c\u6210\u3057\u3066\u3044\u308b\u56fd\u30fb\u5730\u57df\u306b\u9069\u7528\u3055\u308c\u308b\u898f\u5236\u5f62\u5f0f\u3084\u6642\u671f\u3092\u542b\u3080\u898f\u5236\u306b\u6e96\u62e0\u3059\u308b\u3002<\/li>\n<\/ul>\n<p>RA\u304cRMP\u306e\u8981\u7d20\u3092\u4f1a\u793e\u306e\u898b\u89e3\u3068\u306f\u7570\u306a\u308b\u3082\u306e\u306b\u3059\u308b\u3053\u3068\u3092\u8981\u6c42\u3059\u308b\u5834\u5408\u3001\u305d\u308c\u3089\u306e\u8981\u7d20\u306fRA\u304c\u63d0\u4f9b\u3057\u305f\u3001\u307e\u305f\u306fRA\u3068\u5408\u610f\u3057\u305f\u4ed5\u69d8\u3068\u4e00\u81f4\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002<\/p>\n<h2><span class=\"ez-toc-section\" id=\"European_Risk_Management_Plan_Model\"><\/span><strong>\u6b27\u5dde\u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30d7\u30e9\u30f3\u30e2\u30c7\u30eb<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>EMA\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306e\u5b9a\u7fa9\u306b\u3088\u308b\u3068\u3001\u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30d7\u30e9\u30f3\uff08RMP\uff09\u306f\u3001\u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30b7\u30b9\u30c6\u30e0\u306e\u305f\u3081\u306e\u6587\u66f8\u3068\u3057\u3066\u63d0\u793a\u3055\u308c\u3066\u3044\u307e\u3059\u3002RMP\u306f\u3001\u533b\u85ac\u54c1\u306e\u30ea\u30b9\u30af\u3092\u7279\u5b9a\u3057\u3001\u793a\u3057\u3001\u4f4e\u6e1b\u3059\u308b\u305f\u3081\u306e\u6587\u66f8\u3067\u3042\u308b\u3002<\/p>\n<p>RMP\u30e2\u30c7\u30eb\u306f\u3001\u3053\u306e\u3088\u3046\u306a\u70b9\u3092\u8e0f\u307e\u3048\u3066\u4f5c\u6210\u3055\u308c\u3066\u3044\u307e\u3059\u3002<\/p>\n<ul>\n<li>\u5b89\u5168\u6027\u306e\u7a2e-\u533b\u85ac\u54c1\u306e\u5b89\u5168\u6027\u30d7\u30ed\u30d5\u30a1\u30a4\u30eb\u306e\u8a8d\u8a3c\u3068\u3001\u7279\u5b9a\u3055\u308c\u305f\u4e3b\u8981\u306a\u6f5c\u5728\u7684\u30ea\u30b9\u30af\u304a\u3088\u3073\u73fe\u5728\u5b58\u5728\u3057\u306a\u3044\u60c5\u5831\u3092\u5f37\u8abf\u3057\u3001\u3055\u3089\u306b\u5bfe\u51e6\u3059\u308b\u5fc5\u8981\u306e\u3042\u308b\u5b89\u5168\u6027\u306e\u4e8b\u9805\u3092\u793a\u3059\u3053\u3068\u3002<\/li>\n<li>\u30d5\u30a1\u30fc\u30de\u30b3\u30d3\u30b8\u30e9\u30f3\u30b9\u8a08\u753b - \u81e8\u5e8a\u7684\u306b\u9069\u5207\u306a\u30ea\u30b9\u30af\u3092\u767a\u898b\u3057\u3001\u65b0\u305f\u306a\u85ac\u7269\u6709\u5bb3\u53cd\u5fdc\uff08ADR\uff09\u3092\u691c\u8a3c\u3059\u308b\u3053\u3068\u3092\u76ee\u7684\u3068\u3057\u305f\u30d5\u30a1\u30fc\u30de\u30b3\u30d3\u30b8\u30e9\u30f3\u30b9\u6d3b\u52d5\u306e\u8a08\u753b\u3067\u3042\u308b\u3002<\/li>\n<li>\u30ea\u30b9\u30af\u8efd\u6e1b\u8a08\u753b - \u30ea\u30b9\u30af\u8efd\u6e1b\u306e\u8a08\u753b\u3068\u5b9f\u884c\u306b\u95a2\u3059\u308b\u3082\u306e\u3002<\/li>\n<\/ul>\n<p>\u3053\u306e\u6587\u66f8\u306f\u3001\u79d1\u5b66\u7684\u77e5\u8b58\u306b\u57fa\u3065\u3044\u3066\u4f5c\u6210\u3055\u308c\u306a\u3051\u308c\u3070\u306a\u3089\u305a\u3001\u5e83\u544a\u7684\u8981\u7d20\u3092\u542b\u3093\u3067\u306f\u306a\u308a\u307e\u305b\u3093\u3002RMP\u5c02\u9580\u5bb6\u306f\u3001\u8aad\u8005\u304c\u533b\u85ac\u54c1\u306e\u5b89\u5168\u6027\u306e\u6982\u8981\u3092\u7406\u89e3\u3059\u308b\u305f\u3081\u306b\u3069\u306e\u3088\u3046\u306a\u60c5\u5831\u304c\u91cd\u8981\u3067\u3042\u308b\u304b\u306b\u7126\u70b9\u3092\u5f53\u3066\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002<\/p>\n<p>MA\u4fdd\u6709\u8005\u306f\u3001\u5fc5\u8981\u306b\u5fdc\u3058\u3066eCTD\u307e\u305f\u306fPSUR\u306e\u8981\u6c42\u6587\u66f8\u306e\u9069\u5207\u306a\u30bb\u30af\u30b7\u30e7\u30f3\u306b\u53c2\u7167\u60c5\u5831\u3092\u8ffd\u52a0\u3059\u308b\u8cac\u4efb\u8005\u3068\u307f\u306a\u3055\u308c\u307e\u3059\u3002<\/p>\n<p>RMP\u306e\u4f5c\u6210\u3084\u6539\u8a02\u306e\u304d\u3063\u304b\u3051\u306f\u3001\u4ee5\u4e0b\u306e\u3088\u3046\u306a\u3082\u306e\u304c\u8003\u3048\u3089\u308c\u307e\u3059\u304c\u3001\u3053\u308c\u3089\u306b\u9650\u5b9a\u3055\u308c\u308b\u3082\u306e\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002<\/p>\n<ul>\n<li>RA\u304b\u3089\u306e\u30ea\u30af\u30a8\u30b9\u30c8\u306e\u53d7\u4fe1<\/li>\n<li>\u88fd\u54c1RM\u6226\u7565\u306e\u65b0\u898f\u307e\u305f\u306f\u6539\u8a02\u306b\u57fa\u3065\u304f\u30ea\u30b9\u30af\u7ba1\u7406\u59d4\u54e1\u4f1a\uff08RMC\uff09\u304b\u3089\u306e\u8981\u8acb\u306e\u53d7\u9818<\/li>\n<li>\u88fd\u9020\u8ca9\u58f2\u627f\u8a8d\u7533\u8acb\u66f8\uff08MAA\uff09\u306e\u65b0\u898f\u4f5c\u6210\u307e\u305f\u306f\u66f4\u65b0<\/li>\n<li>\u88fd\u54c1\u8ca9\u58f2\u8a31\u53ef\u8a3c\u306e\u53d6\u5f97\u3068\u7dad\u6301\u3001\u307e\u305f\u306f\u30e9\u30a4\u30bb\u30f3\u30b9\u306e\u66f4\u65b0<\/li>\n<\/ul>\n<h2><span class=\"ez-toc-section\" id=\"List_for_writing_or_evaluating_an_RMP\"><\/span>RMP\u3092\u4f5c\u6210\u307e\u305f\u306f\u8a55\u4fa1\u3059\u308b\u305f\u3081\u306e\u30ea\u30b9\u30c8<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\u533b\u85ac\u54c1\u306eRMP\u306e\u4f5c\u6210\u3084\u8a55\u4fa1\u3092\u76ee\u7684\u3068\u3057\u305f\u5168\u4f53\u306e\u30d1\u30fc\u30c4\u3092\u63b2\u8f09\u3057\u3066\u3044\u307e\u3059\u3002<\/p>\n<p>\u5b89\u5168\u306e\u7a2e<\/p>\n<ul>\n<li>\u5b89\u5168\u6027\u30d7\u30ed\u30d5\u30a1\u30a4\u30eb\u306e\u95a2\u9023\u90e8\u5206\u304c\u542b\u307e\u308c\u3066\u3044\u308b\u3053\u3068<\/li>\n<li>\u5b89\u5168\u30c7\u30fc\u30bf\u30b7\u30fc\u30c8\u3092\u4f5c\u6210\u3059\u308b\u969b\u306b\u306f\u3001\u95a2\u9023\u3059\u308b\u30c7\u30fc\u30bf\u3092\u8003\u616e\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/li>\n<li>\u30bf\u30fc\u30b2\u30c3\u30c8\u30b0\u30eb\u30fc\u30d7\u306e\u3059\u3079\u3066\u306e\u90e8\u5206\u304c\u8abf\u67fb\u3055\u308c\u3066\u3044\u306a\u3044\u5834\u5408\u3001\u6f5c\u5728\u7684\u306a\u30ea\u30b9\u30af\u3084\u4e0d\u8db3\u3057\u3066\u3044\u308b\u60c5\u5831\u306b\u95a2\u3057\u3066\u3001\u95a2\u9023\u3059\u308b\u30bb\u30ad\u30e5\u30ea\u30c6\u30a3\u4e0a\u306e\u61f8\u5ff5\u3092\u542b\u3081\u308b\u5fc5\u8981\u304c\u3042\u308b<\/li>\n<li>\u5b89\u5168\u6027\u30c7\u30fc\u30bf\u30d9\u30fc\u30b9\u306e\u9650\u754c\u3068\u3001\u9650\u754c\u304c\u533b\u85ac\u54c1\u306e\u5b89\u5168\u6027\u30d7\u30ed\u30d5\u30a1\u30a4\u30eb\u306b\u53ca\u307c\u3059\u5f71\u97ff\u3092\u8003\u616e\u3059\u308b\u5fc5\u8981\u304c\u3042\u308b\u3002<\/li>\n<li>\u30ea\u30d5\u30a1\u30ec\u30f3\u30b9\u30fb\u30e1\u30c7\u30a3\u30b9\u30f3\u306e\u30a2\u30d7\u30ea\u30b1\u30fc\u30b7\u30e7\u30f3\u3067\u306f\u3001\u6700\u65b0\u306eRPM\u306b\u3088\u308b\u3059\u3079\u3066\u306e\u5b89\u5168\u6027\u3092\u63d0\u4f9b\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/li>\n<\/ul>\n<h2><span class=\"ez-toc-section\" id=\"Plan_of_Pharmacovigilance\"><\/span>\u30d5\u30a1\u30fc\u30de\u30b3\u30d3\u30b8\u30e9\u30f3\u30b9\u306e\u8a08\u753b<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<ul>\n<li>\u5b89\u5168\u6027\u30c7\u30fc\u30bf\u30b7\u30fc\u30c8\u306b\u8a18\u8f09\u3055\u308c\u3066\u3044\u308b\u5b89\u5168\u4e0a\u306e\u554f\u984c\u306f\u3001\u30d5\u30a1\u30fc\u30de\u30b3\u30d3\u30b8\u30e9\u30f3\u30b9\u8a08\u753b\u3067\u5bfe\u51e6\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002<\/li>\n<li>\u901a\u5e38\u306e\u30d5\u30a1\u30fc\u30de\u30b3\u30d3\u30b8\u30e9\u30f3\u30b9\u6d3b\u52d5\u3067\u5341\u5206\u3067\u3042\u308a\u3001\u5fc5\u8981\u306b\u5fdc\u3058\u3066\u8ffd\u52a0\u306e\u30d5\u30a1\u30fc\u30de\u30b3\u30d3\u30b8\u30e9\u30f3\u30b9\u6d3b\u52d5\u3092\u884c\u3046\u3079\u304d\u3067\u3042\u308b\u3002<\/li>\n<li>\u30d5\u30a1\u30fc\u30de\u30b3\u30d3\u30b8\u30e9\u30f3\u30b9\u8a08\u753b\u306b\u304a\u3051\u308b\u884c\u52d5\u306f\u3001\u30ea\u30b9\u30af\u3092\u7279\u5b9a\u3059\u308b\u305f\u3081\u306b\u3001\u307e\u305f\u306f\u4e0d\u8db3\u3057\u3066\u3044\u308b\u60c5\u5831\u3092\u63d0\u4f9b\u3059\u308b\u305f\u3081\u306b\u3001\u660e\u3089\u304b\u306b\u7279\u5b9a\u3055\u308c\u3001\u6982\u8aac\u3055\u308c\u3001\u304b\u3064\u9069\u5207\u3067\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002<\/li>\n<li>\u4ee3\u7406\u5e97\u304c\u5b9f\u65bd\u3057\u305f\u5b89\u5168\u6027\u8abf\u67fb......\u6761\u4ef6\u3092\u660e\u78ba\u306b\u3059\u308b\u3053\u3068<\/li>\n<li>\u6295\u85ac\u30df\u30b9\u306b\u95a2\u9023\u3059\u308b\u5b89\u5168\u6027\u3092\u8003\u616e\u3057\u305f\u5834\u5408\u3001RPM\u306b\u306f\u85ac\u306e\u6b63\u3057\u3044\u4f7f\u7528\u3092\u76e3\u8996\u3059\u308b\u305f\u3081\u306e\u9069\u5207\u306a\u624b\u6bb5\u3092\u542b\u3081\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/li>\n<li>The offered additional <a href=\"https:\/\/www.kolabtree.com\/blog\/ja\/ensuring-reproducibility-in-ai-driven-research-how-freelance-experts-can-help-in-biotech-and-healthcare\/\">\u30ea\u30b5\u30fc\u30c1<\/a> must be necessary, attainable, non-advertisable and able of provide the necessary additional specification of the risk and answering scientific questions<\/li>\n<li>\u671f\u9650\u3084\u30de\u30a4\u30eb\u30b9\u30c8\u30fc\u30f3\u306f\u3001\u7d50\u679c\u306e\u767a\u8868\u3092\u542b\u3081\u3001\u63d0\u6848\u3055\u308c\u305f\u30a2\u30af\u30b7\u30e7\u30f3\u306b\u95a2\u9023\u3057\u305f\u3082\u306e\u3067\u3042\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/li>\n<\/ul>\n<h2><span class=\"ez-toc-section\" id=\"Post-authorization_efficacy_studies_plan\"><\/span>\u627f\u8a8d\u5f8c\u306e\u6709\u52b9\u6027\u8a66\u9a13\u8a08\u753b<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<ul>\n<li>\u627f\u8a8d\u3055\u308c\u305f\u30de\u30fc\u30b1\u30c6\u30a3\u30f3\u30b0\u306e\u6761\u4ef6\u3068\u3057\u3066\u3001\u307e\u305f\u306f\u7279\u5225\u306a\u8cac\u4efb\u3068\u3057\u3066\u3001\u3059\u3079\u3066\u306ePAES\u3092\u542b\u3081\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/li>\n<\/ul>\n<h3><span class=\"ez-toc-section\" id=\"Risk_mitigation_plan\"><\/span>\u30ea\u30b9\u30af\u8efd\u6e1b\u8a08\u753b<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<ul>\n<li>\u901a\u5e38\u306e\u30ea\u30b9\u30af\u8efd\u6e1b\u7b56\u304c\u5341\u5206\u3067\u3042\u308b\u3053\u3068\u3001\u307e\u305f\u306f\u5fc5\u8981\u306b\u5fdc\u3058\u3066\u8ffd\u52a0\u306e\u30ea\u30b9\u30af\u8efd\u6e1b\u7b56\u3092\u7279\u5b9a\u3059\u308b\u3053\u3068<\/li>\n<li>\u30ea\u30b9\u30af\u3092\u6700\u5c0f\u5316\u3059\u308b\u305f\u3081\u306b\u8ffd\u52a0\u306e\u63aa\u7f6e\u304c\u63d0\u6848\u3055\u308c\u305f\u5834\u5408\u3001\u305d\u306e\u63aa\u7f6e\u306f\u5341\u5206\u306b\u6b63\u5f53\u5316\u3055\u308c\u3001\u30ea\u30b9\u30af\u306b\u6bd4\u4f8b\u3057\u305f\u3082\u306e\u3067\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002\u3059\u3079\u3066\u306e\u52a0\u76df\u56fd\u3067\u306e\u5b9f\u65bd\u3092\u8003\u616e\u3059\u3079\u304d\u3067\u3042\u308b\u3002<\/li>\n<li>\u30ea\u30b9\u30af\u3092\u6700\u5c0f\u5316\u3059\u308b\u305f\u3081\u306e\u8ffd\u52a0\u63aa\u7f6e\u306e\u6709\u52b9\u6027\u306e\u57fa\u6e96\u306f\u3001\u5148\u9a13\u7684\u306b\u6c7a\u5b9a\u3055\u308c\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044<\/li>\n<li>\u30ea\u30b9\u30af\u8efd\u6e1b\u63aa\u7f6e\u306e\u6709\u52b9\u6027\u3092\u8a55\u4fa1\u3059\u308b\u65b9\u6cd5\u304c\u5341\u5206\u306b\u8aac\u660e\u3055\u308c\u3001\u9069\u5207\u3067\u3042\u308b\u3053\u3068<\/li>\n<\/ul>\n<h3><span class=\"ez-toc-section\" id=\"Summary_for_Risk_management_plan\"><\/span>\u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30d7\u30e9\u30f3\u306e\u6982\u8981<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<ul>\n<li>RMP\u306e\u63d0\u51fa\u304c\u6b63\u3057\u3044\u3053\u3068<\/li>\n<li>\u5e83\u544a\u7684\u8981\u7d20\u3092\u6392\u9664\u3057\u3001\u9069\u5207\u306a\u65b9\u6cd5\u3067\u4e8b\u5b9f\u3092\u63d0\u793a\u3059\u308b\u3053\u3068\u3002<\/li>\n<\/ul>\n<h2><span class=\"ez-toc-section\" id=\"United_State_FDA_General_quality_Risk_Management_Process\"><\/span><strong>\u7c73\u56fd(FDA)\u4e00\u822c\u54c1\u8cea\u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30d7\u30ed\u30bb\u30b9<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\u54c1\u8cea\u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u3068\u306f\u3001\u88fd\u54c1\u306e\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u3092\u901a\u3058\u305f\u533b\u85ac\u54c1\u306e\u54c1\u8cea\u306b\u5bfe\u3059\u308b\u30ea\u30b9\u30af\u306e\u8a55\u4fa1\u3001\u7ba1\u7406\u3001\u4f1d\u9054\u3001\u898b\u76f4\u3057\u3092\u884c\u3046\u4f53\u7cfb\u7684\u306a\u30d7\u30ed\u30bb\u30b9\u3067\u3059\u3002<\/p>\n<h3><span class=\"ez-toc-section\" id=\"Main_Responsibilities\"><\/span><strong>\u4e3b\u306a\u62c5\u5f53\u696d\u52d9<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>\u54c1\u8cea\u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u6d3b\u52d5\u306f\u3001\u901a\u5e38\u3001\u5b66\u969b\u7684\u306a\u30c1\u30fc\u30e0\u306b\u3088\u3063\u3066\u884c\u308f\u308c\u307e\u3059\u304c\u3001\u5fc5\u305a\u3057\u3082\u305d\u3046\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u30c1\u30fc\u30e0\u3092\u7d50\u6210\u3059\u308b\u969b\u306b\u306f\u3001\u54c1\u8cea\u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u306e\u30d7\u30ed\u30bb\u30b9\u306b\u7cbe\u901a\u3057\u305f\u4eba\u6750\u306b\u52a0\u3048\u3066\u3001\u54c1\u8cea\u90e8\u9580\u3001\u4e8b\u696d\u958b\u767a\u3001\u30a8\u30f3\u30b8\u30cb\u30a2\u30ea\u30f3\u30b0\u3001\u898f\u5236\u95a2\u9023\u3001\u751f\u7523\u696d\u52d9\u3001\u8ca9\u58f2\u30fb\u30de\u30fc\u30b1\u30c6\u30a3\u30f3\u30b0\u3001\u6cd5\u52d9\u3001\u7d71\u8a08\u3001\u81e8\u5e8a\u306a\u3069\u306e\u9069\u5207\u306a\u5206\u91ce\u306e\u5c02\u9580\u5bb6\u304c\u53c2\u52a0\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002<\/p>\n<p>\u610f\u601d\u6c7a\u5b9a\u8005\u306f<\/p>\n<ul>\n<li>\u7d44\u7e54\u5185\u306e\u69d8\u3005\u306a\u6a5f\u80fd\u3084\u90e8\u9580\u306b\u304a\u3051\u308b\u54c1\u8cea\u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u306e\u8abf\u6574\u306b\u8cac\u4efb\u3092\u6301\u3064\u3002<\/li>\n<li>\u54c1\u8cea\u30ea\u30b9\u30af\u7ba1\u7406\u30d7\u30ed\u30bb\u30b9\u304c\u5b9a\u7fa9\u3055\u308c\u3001\u5c55\u958b\u3055\u308c\u3001\u30ec\u30d3\u30e5\u30fc\u3055\u308c\u3001\u9069\u5207\u306a\u30ea\u30bd\u30fc\u30b9\u304c\u5229\u7528\u53ef\u80fd\u3067\u3042\u308b\u3053\u3068\u3092\u4fdd\u8a3c\u3059\u308b\u3002<\/li>\n<\/ul>\n<h3><span class=\"ez-toc-section\" id=\"Initiating_a_Quality_Risk_Management_Process_QRMP\"><\/span><strong>\u54c1\u8cea\u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30d7\u30ed\u30bb\u30b9\uff08QRMP\uff09\u306e\u958b\u59cb<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>\u54c1\u8cea\u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30d7\u30ed\u30bb\u30b9\u306b\u306f\u3001\u30ea\u30b9\u30af\u306b\u95a2\u3059\u308b\u79d1\u5b66\u7684\u6839\u62e0\u306b\u57fa\u3065\u304f\u610f\u601d\u6c7a\u5b9a\u3092\u8abf\u6574\u3001\u4fc3\u9032\u3001 \u6539\u5584\u3059\u308b\u305f\u3081\u306b\u8a2d\u8a08\u3055\u308c\u305f\u4f53\u7cfb\u7684\u306a\u30d7\u30ed\u30bb\u30b9\u304c\u542b\u307e\u308c\u308b\u3079\u304d\u3067\u3042\u308b\u3002\u54c1\u8cea\u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30d7\u30ed\u30bb\u30b9\u3092\u958b\u59cb\u3057\u3001\u8a08\u753b\u3059\u308b\u305f\u3081\u306b\u4f7f\u7528\u3059\u308b\u95a2\u9023\u624b\u9806\u306b\u306f\u3001\u4ee5\u4e0b\u306e\u3082\u306e\u304c\u3042\u308b\u3002<\/p>\n<ul>\n<li>\u30ea\u30b9\u30af\u306e\u53ef\u80fd\u6027\u3092\u7279\u5b9a\u3059\u308b\u9069\u5207\u306a\u4eee\u5b9a\u3092\u542b\u3080\u3001\u554f\u984c\u304a\u3088\u3073\/\u307e\u305f\u306f\u30ea\u30b9\u30af\u306e\u8cea\u554f\u306e\u5b9a\u7fa9<\/li>\n<li>\u30ea\u30b9\u30af\u30a2\u30bb\u30b9\u30e1\u30f3\u30c8\u306b\u95a2\u9023\u3059\u308b\u6f5c\u5728\u7684\u306a\u30cf\u30b6\u30fc\u30c9\u3001\u5371\u5bb3\u3001\u4eba\u306e\u5065\u5eb7\u3078\u306e\u5f71\u97ff\u306b\u95a2\u3059\u308b\u80cc\u666f\u60c5\u5831\u3084\u30c7\u30fc\u30bf\u306e\u53ce\u96c6<\/li>\n<li>\u30ea\u30fc\u30c0\u30fc\u3068\u30af\u30ea\u30c6\u30a3\u30ab\u30eb\u30ea\u30bd\u30fc\u30b9\u306e\u7279\u5b9a<\/li>\n<li>\u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30d7\u30ed\u30bb\u30b9\u306e\u30bf\u30a4\u30e0\u30e9\u30a4\u30f3\u3001\u6210\u679c\u7269\u3001\u304a\u3088\u3073\u9069\u5207\u306a\u610f\u601d\u6c7a\u5b9a\u30ec\u30d9\u30eb\u306e\u660e\u793a<\/li>\n<\/ul>\n<h3><span class=\"ez-toc-section\" id=\"Assessment_for_Risk\"><\/span>\u30ea\u30b9\u30af\u306e\u8a55\u4fa1<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>\u30ea\u30b9\u30af\u30a2\u30bb\u30b9\u30e1\u30f3\u30c8\u3092\u5b9f\u65bd\u3059\u308b\u4e3b\u306a\u5f79\u5272\u306f\u3001\u30ea\u30b9\u30af\u3092\u7279\u5b9a\u3057\u3001\u305d\u306e\u30ea\u30b9\u30af\u3078\u306e\u66dd\u9732\u306b\u95a2\u9023\u3059\u308b\u95a2\u9023\u6027\u3092\u8a55\u4fa1\u3059\u308b\u3053\u3068\u3067\u3042\u308b\u3002\u54c1\u8cea\u8a55\u4fa1\u306e\u958b\u59cb\u30ea\u30b9\u30af\u306f\u3001\u660e\u78ba\u306a\u554f\u984c\u306e\u8aac\u660e\u53c8\u306f\u30ea\u30b9\u30af\u306e\u8cea\u554f\u304b\u3089\u59cb\u3081\u308b\u3079\u304d\u3067\u3042\u308b\u3002\u554f\u984c\u3068\u306a\u3063\u3066\u3044\u308b\u30ea\u30b9\u30af\u304c\u660e\u78ba\u3067\u3042\u308c\u3070\u3001\u9069\u5207\u306a\u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30c4\u30fc\u30eb\u3084\u3001\u30ea\u30b9\u30af\u306e\u554f\u984c\u306b\u5bfe\u51e6\u3059\u308b\u305f\u3081\u306e\u60c5\u5831\u306e\u7a2e\u985e\u304c\u3001\u3059\u3050\u306b\u8a8d\u8b58\u3067\u304d\u307e\u3059\u3002\u30ea\u30b9\u30af\u30a2\u30bb\u30b9\u30e1\u30f3\u30c8\u306e\u76ee\u7684\u306b\u5bfe\u3059\u308b\u30ea\u30b9\u30af\u3092\u660e\u78ba\u306b\u6c7a\u5b9a\u3059\u308b\u305f\u3081\u306e\u88dc\u52a9\u3068\u3057\u3066\u30013\u3064\u306e\u57fa\u672c\u7684\u306a\u30dd\u30a4\u30f3\u30c8\u3092\u63d0\u6848\u3059\u308b\u3002<\/p>\n<ol>\n<li>\u9593\u9055\u3063\u305f\u65b9\u5411\u306b\u9032\u3093\u3067\u3057\u307e\u3046\u3053\u3068\u3092\u8003\u3048\u308b\u3068<\/li>\n<li>\u6b63\u3057\u3044\u65b9\u5411\u306b\u9032\u307e\u306a\u3044\u53ef\u80fd\u6027\u3092\u8003\u616e\u3059\u308b<\/li>\n<li>\u53cd\u97ff\u3092\u898b\u5b88\u308b\u305f\u3081\u306b<\/li>\n<\/ol>\n<p>\u30ea\u30b9\u30af\u306e\u8b58\u5225\u300d\u3068\u306f\u3001\u30ea\u30b9\u30af\u306b\u95a2\u3059\u308b\u8cea\u554f\u3084\u554f\u984c\u306e\u8a18\u8ff0\u306b\u95a2\u9023\u3059\u308b\u30ea\u30b9\u30af\u306e\u8b58\u5225\u306b \u5f79\u7acb\u3064\u60c5\u5831\u3092\u4f53\u7cfb\u7684\u306b\u5229\u7528\u3059\u308b\u3053\u3068\u3068\u8003\u3048\u3089\u308c\u308b\u3002\u60c5\u5831\u306b\u306f\u3001\u904e\u53bb\u306e\u30c7\u30fc\u30bf\u3001\u7406\u8ad6\u7684\u5206\u6790\u3001\u60c5\u5831\u306b\u57fa\u3065\u3044\u305f\u610f\u898b\u3001\u5229\u5bb3\u95a2\u4fc2\u8005\u306e\u61f8\u5ff5\u306a\u3069\u304c\u542b\u307e\u308c\u308b\u3002\u30ea\u30b9\u30af\u306e\u7279\u5b9a\u306f\u3001\u300c\u4f55\u304c\u6b63\u3057\u3044\u65b9\u6cd5\u3067\u306f\u306a\u3044\u304b\u3082\u3057\u308c\u306a\u3044\u306e\u304b\u300d\u3068\u3044\u3046\u7591\u554f\u306b\u5bfe\u51e6\u3059\u308b\u3082\u306e\u3067\u3042\u308a\u3001\u7279\u5b9a\u3067\u304d\u308b\u53ef\u80fd\u6027\u306e\u3042\u308b\u7d50\u679c\u3092\u542b\u307f\u307e\u3059\u3002\u3053\u308c\u306f\u3001\u54c1\u8cea\u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30d7\u30ed\u30bb\u30b9\u306e\u3055\u3089\u306a\u308b\u30b9\u30c6\u30c3\u30d7\u306e\u57fa\u790e\u3068\u306a\u308b\u3002<\/p>\n<p>\u30ea\u30b9\u30af\u306b\u5bfe\u3059\u308b\u5206\u6790\u3068\u306f\u3001\u4e8b\u6545\u306e\u8d77\u3053\u308a\u3084\u3059\u3055\u3068\u640d\u5bb3\u8ce0\u511f\u306e\u53b3\u3057\u3055\u3092\u7d50\u3073\u3064\u3051\u308b\u305f\u3081\u306e\u5b9a\u6027\u7684\u307e\u305f\u306f\u5b9a\u91cf\u7684\u306a\u30d7\u30ed\u30bb\u30b9\u3067\u3042\u308b\u3002\u8a00\u3044\u63db\u3048\u308c\u3070\u3001\u7279\u5b9a\u3055\u308c\u305f\u30cf\u30b6\u30fc\u30c9\u306b\u95a2\u9023\u3059\u308b\u30ea\u30b9\u30af\u3092\u63a8\u5b9a\u3059\u308b\u3053\u3068\u3067\u3059\u3002<\/p>\n<p>\u30ea\u30b9\u30af\u306e\u8a55\u4fa1\u306f\u3001\u8b58\u5225\u3055\u308c\u5206\u6790\u3055\u308c\u305f\u30ea\u30b9\u30af\u3092\u6240\u5b9a\u306e\u30ea\u30b9\u30af\u57fa\u6e96\u3068\u6bd4\u8f03\u3059\u308b\u3002\u30ea\u30b9\u30af\u8a55\u4fa1\u3067\u306f\u30013\u3064\u306e\u57fa\u672c\u7684\u306a\u8cea\u554f\u3059\u3079\u3066\u306b\u5bfe\u3059\u308b\u8a3c\u62e0\u306e\u5f37\u3055\u3092\u8003\u616e\u3057\u307e\u3059\u3002<\/p>\n<h3><span class=\"ez-toc-section\" id=\"Control_for_Risk\"><\/span>\u30ea\u30b9\u30af\u306b\u5bfe\u3059\u308b\u30b3\u30f3\u30c8\u30ed\u30fc\u30eb<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>\u30ea\u30b9\u30af\u30b3\u30f3\u30c8\u30ed\u30fc\u30eb\u306e\u76ee\u7684\u306f\u3001\u7279\u5b9a\u3055\u308c\u305f\u30ea\u30b9\u30af\u3092\u4f4e\u6e1b\u304a\u3088\u3073\uff0f\u307e\u305f\u306f\u53d7\u5bb9\u3059\u308b\u305f\u3081\u306e\u6c7a\u5b9a\u3092\u884c\u3046\u3053\u3068\u3067\u3042\u308b\u3002\u7406\u60f3\u7684\u306b\u306f\u3001\u30ea\u30b9\u30af\u30b3\u30f3\u30c8\u30ed\u30fc\u30eb\u3092\u884c\u3046\u3053\u3068\u306b\u3088\u308a\u3001\u7279\u5b9a\u3055\u308c\u305f\u30ea\u30b9\u30af\u306e\u30ec\u30d9\u30eb\u3092\u53d7\u5bb9\u53ef\u80fd\u306a \u30ec\u30d9\u30eb\u307e\u3067\u4f4e\u6e1b\u3055\u305b\u308b\u3079\u304d\u3067\u3042\u308b\u3002\u30ea\u30b9\u30af\u30b3\u30f3\u30c8\u30ed\u30fc\u30eb\u306e\u305f\u3081\u306b\u4f7f\u7528\u3059\u308b\u52b4\u529b\u306f\u3001\u30ea\u30b9\u30af\u306e\u91cd\u8981\u6027\u306b\u6bd4\u4f8b\u3059\u308b\u3079\u304d\u3067\u3042\u308b\u3002\u30ea\u30b9\u30af\u30b3\u30f3\u30c8\u30ed\u30fc\u30eb\u306e\u6700\u9069\u306a\u30ec\u30d9\u30eb\u3092\u7406\u89e3\u3059\u308b\u305f\u3081\u306b\u306f\u3001\u610f\u601d\u6c7a\u5b9a\u8005\u306f\u5229\u76ca\u30b3\u30b9\u30c8\u5206\u6790\u306a\u3069\u306e\u69d8\u3005\u306a\u30d7\u30ed\u30bb\u30b9\u3092\u7528\u3044\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002\u30ea\u30b9\u30af\u30b3\u30f3\u30c8\u30ed\u30fc\u30eb\u306e\u305f\u3081\u306e\u91cd\u8981\u306a\u30dd\u30a4\u30f3\u30c8\u306f\u6b21\u306e\u3068\u304a\u308a\u3067\u3042\u308b\u3002<\/p>\n<ul>\n<li>\u30ea\u30b9\u30af\u304c\u8a31\u5bb9\u30ec\u30d9\u30eb\u3092\u8d85\u3048\u3066\u3044\u308b\u304b\u3069\u3046\u304b\u3092\u8003\u616e\u3059\u308b<\/li>\n<li>\u30ea\u30b9\u30af\u3092\u4f4e\u6e1b\u307e\u305f\u306f\u6392\u9664\u3059\u308b\u305f\u3081\u306e\u30a2\u30af\u30b7\u30e7\u30f3<\/li>\n<li>\u30e1\u30ea\u30c3\u30c8\u3001\u30ea\u30b9\u30af\u3001\u30ea\u30bd\u30fc\u30b9\u306e\u9069\u5207\u306a\u30d0\u30e9\u30f3\u30b9\u3092\u898b\u6975\u3081\u308b<\/li>\n<li>\u7279\u5b9a\u3057\u305f\u30ea\u30b9\u30af\u3092\u30b3\u30f3\u30c8\u30ed\u30fc\u30eb\u3057\u305f\u7d50\u679c\u3001\u65b0\u305f\u306a\u30ea\u30b9\u30af\u304c\u767a\u751f\u3059\u308b\u304b\u3069\u3046\u304b\u306e\u5224\u65ad<\/li>\n<\/ul>\n<h3><span class=\"ez-toc-section\" id=\"Communication_for_Risk\"><\/span>\u30ea\u30b9\u30af\u306b\u5bfe\u3059\u308b\u30b3\u30df\u30e5\u30cb\u30b1\u30fc\u30b7\u30e7\u30f3<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>\u30ea\u30b9\u30af\u30b3\u30df\u30e5\u30cb\u30b1\u30fc\u30b7\u30e7\u30f3\u3068\u306f\u3001\u610f\u601d\u6c7a\u5b9a\u8005\u3068\u305d\u308c\u4ee5\u5916\u306e\u4eba\u3068\u306e\u9593\u3067\u3001\u30ea\u30b9\u30af\u3068\u30ea\u30b9\u30af\u30de\u30cd\u30b8 \u30e1\u30f3\u30c8\u306b\u95a2\u9023\u3059\u308b\u60c5\u5831\u3092\u5171\u6709\u3059\u308b\u3053\u3068\u3067\u3042\u308b\u3002\u30b3\u30df\u30e5\u30cb\u30b1\u30fc\u30b7\u30e7\u30f3\u306f\u3001\u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30d7\u30ed\u30bb\u30b9\u306e\u3069\u306e\u6bb5\u968e\u3067\u3082\u53ef\u80fd\u3067\u3042\u308b\u3002\u8cea\u306e\u9ad8\u3044\u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30d7\u30ed\u30bb\u30b9\u306e\u51fa\u529b\uff0f\u7d50\u679c\u306f\u3001\u9069\u5207\u306b\u4f1d\u9054\u3055\u308c\u3001\u6587\u66f8\u5316\u3055\u308c\u308b\u3079\u304d \u3067\u3042\u308b\u3002\u30b3\u30df\u30e5\u30cb\u30b1\u30fc\u30b7\u30e7\u30f3\u306b\u306f\u3001\u5229\u5bb3\u95a2\u4fc2\u8005\u9593\uff08\u4f8b\u3048\u3070\u3001\u898f\u5236\u5f53\u5c40\u3068\u7523\u696d\u754c\u3001\u7523\u696d\u754c\u3068\u60a3\u8005\u3001 \u4f01\u696d\u3001\u7523\u696d\u754c\u3001\u53c8\u306f\u898f\u5236\u5f53\u5c40\u5185\uff09\u306e\u30b3\u30df\u30e5\u30cb\u30b1\u30fc\u30b7\u30e7\u30f3\u304c\u542b\u307e\u308c\u308b\u3002\u542b\u307e\u308c\u308b\u60c5\u5831\u306f\u3001\u54c1\u8cea\u306b\u5bfe\u3059\u308b\u30ea\u30b9\u30af\u306e\u5b58\u5728\u3001\u6027\u8cea\u3001\u5f62\u614b\u3001\u78ba\u7387\u3001\u91cd\u5927\u6027\u3001\u53d7\u5bb9\u53ef\u80fd \u6027\u3001\u7ba1\u7406\u3001\u51e6\u7f6e\u3001\u691c\u51fa\u53ef\u80fd\u6027\u3001\u53c8\u306f\u305d\u306e\u4ed6\u306e\u5074\u9762\u306b\u95a2\u3059\u308b\u3082\u306e\u3067\u3042\u308b\u3002\u30b3\u30df\u30e5\u30cb\u30b1\u30fc\u30b7\u30e7\u30f3\u306f\u3001\u30ea\u30b9\u30af\u306e\u53d7\u5bb9\u3054\u3068\u306b\u884c\u308f\u308c\u308b\u5fc5\u8981\u306f\u306a\u3044\u3002\u7523\u696d\u754c\u3068\u898f\u5236\u5f53\u5c40\u3068\u306e\u9593\u3067\u306f\u3001\u54c1\u8cea\u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u306e\u6c7a\u5b9a\u306b\u95a2\u3059\u308b\u30b3\u30df\u30e5\u30cb\u30b1\u30fc\u30b7\u30e7\u30f3\u306f\u3001 \u898f\u5236\u53ca\u3073\u30ac\u30a4\u30c0\u30f3\u30b9\u306b\u898f\u5b9a\u3055\u308c\u305f\u65e2\u5b58\u306e\u30eb\u30fc\u30c8\u3092\u901a\u3058\u3066\u884c\u308f\u308c\u308b\u3053\u3068\u304c\u3042\u308b\u3002<\/p>\n<h3><span class=\"ez-toc-section\" id=\"Review_for_Risk\"><\/span>\u30ea\u30b9\u30af\u306b\u5bfe\u3059\u308b\u30ec\u30d3\u30e5\u30fc<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>\u30a4\u30d9\u30f3\u30c8\u3092\u30ec\u30d3\u30e5\u30fc\u307e\u305f\u306f\u76e3\u8996\u3059\u308b\u4ed5\u7d44\u307f\u3092\u5c0e\u5165\u3059\u308b\u3053\u3068\u3002\u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30d7\u30ed\u30bb\u30b9\u306e\u30a2\u30a6\u30c8\u30d7\u30c3\u30c8\uff0f\u7d50\u679c\u306f\u3001\u65b0\u3057\u3044\u77e5\u8b58\u3084\u7d4c\u9a13\u3092\u8003\u616e\u306b\u5165\u308c\u3066\u898b\u76f4\u3055\u308c\u308b\u3079\u304d\u3067\u3042\u308b\u3002\u898b\u76f4\u3057\u306e\u983b\u5ea6\u306f\u3001\u30ea\u30b9\u30af\u306e\u30ec\u30d9\u30eb\u306b\u57fa\u3065\u304f\u3079\u304d\u3067\u3042\u308b\u3002\u30ea\u30b9\u30af\u306e\u898b\u76f4\u3057\u306b\u306f\u3001\u30ea\u30b9\u30af\u53d7\u5bb9\u306e\u6c7a\u5b9a\u306e\u518d\u8003\u304c\u542b\u307e\u308c\u308b\u304b\u3082\u3057\u308c\u306a\u3044\u3002<\/p>\n<h2><span class=\"ez-toc-section\" id=\"Management_methodology_of_risk\"><\/span><strong>\u30ea\u30b9\u30af\u306e\u7ba1\u7406\u65b9\u6cd5<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\u57fa\u672c\u7684\u306b\u3001\u54c1\u8cea\u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u306f\u3001\u610f\u601d\u6c7a\u5b9a\u306b\u5bfe\u3059\u308b\u79d1\u5b66\u7684\u304b\u3064\u5b9f\u8df5\u7684\u306a\u30a2\u30d7\u30ed\u30fc\u30c1\u3092\u652f\u63f4\u3059\u308b\u3082\u306e\u3067\u3042\u308b\u3002\u54c1\u8cea\u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u306f\u3001\u30ea\u30b9\u30af\u306e\u78ba\u7387\u3001\u91cd\u5927\u6027\u3001\u305d\u3057\u3066\u6642\u306b\u306f\u691c\u51fa\u53ef\u80fd\u6027\u306e\u8a55\u4fa1\u306b\u95a2\u3059\u308b\u73fe\u5728\u306e\u77e5\u8b58\u306b\u57fa\u3065\u3044\u3066\u3001\u54c1\u8cea\u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30d7\u30ed\u30bb\u30b9\u306e\u30b9\u30c6\u30c3\u30d7\u3092\u9054\u6210\u3059\u308b\u305f\u3081\u306e\u3001\u6587\u66f8\u5316\u3055\u308c\u305f\u3001\u900f\u660e\u6027\u306e\u3042\u308b\u3001\u518d\u73fe\u53ef\u80fd\u306a\u65b9\u6cd5\u3092\u63d0\u4f9b\u3057\u307e\u3059\u3002\u5f93\u6765\u3001\u54c1\u8cea\u306b\u5bfe\u3059\u308b\u30ea\u30b9\u30af\u306f\u3001\u89b3\u5bdf\u7d50\u679c\u3084\u50be\u5411\u3001\u305d\u306e\u4ed6\u306e\u60c5\u5831\u306a\u3069\u306b\u57fa\u3065\u3044\u3066\u3001\u69d8\u3005\u306a\u975e\u516c\u5f0f\u306a\u65b9\u6cd5\uff08\u7d4c\u9a13\u7684\u306a\u624b\u9806\u3084\u5185\u90e8\u7684\u306a\u624b\u9806\uff09\u3067\u8a55\u4fa1\u30fb\u7ba1\u7406\u3055\u308c\u3066\u304d\u307e\u3057\u305f\u3002<\/p>\n<p>\u3055\u3089\u306b\u3001\u88fd\u85ac\u4f01\u696d\u3084\u898f\u5236\u5f53\u5c40\u306f\u3001\u8a8d\u77e5\u3055\u308c\u305f\u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30c4\u30fc\u30eb\u3084\u5185\u90e8\u624b\u9806\uff08\u6a19\u6e96\u64cd\u4f5c\u624b\u9806\u306a\u3069\uff09\u3092\u7528\u3044\u3066\u3001\u30ea\u30b9\u30af\u3092\u8a55\u4fa1\u30fb\u7ba1\u7406\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u308b\u3002<\/p>\n<h2><span class=\"ez-toc-section\" id=\"Management_methods_and_tools_of_risk\"><\/span><strong>\u30ea\u30b9\u30af\u306e\u7ba1\u7406\u65b9\u6cd5\u3068\u30c4\u30fc\u30eb<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\u3053\u306e\u30bb\u30af\u30b7\u30e7\u30f3\u306f\u3001\u7279\u5b9a\u306e\u30c4\u30fc\u30eb\u306b\u3064\u3044\u3066\u3088\u308a\u591a\u304f\u306e\u77e5\u8b58\u3068\u8a73\u7d30\u3092\u5f97\u308b\u305f\u3081\u306e\u88dc\u52a9\u3068\u3057\u3066\u542b\u307e\u308c\u3066\u3044\u307e\u3059\u3002\u91cd\u8981\u306a\u3053\u3068\u306f\u3001\u54c1\u8cea\u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u624b\u9806\u304c\u4f7f\u7528\u3055\u308c\u308b\u3059\u3079\u3066\u306e\u72b6\u6cc1\u306b\u9069\u7528\u3067\u304d\u308b\u5358\u4e00\u306e\u30c4\u30fc\u30eb\u3084\u30c4\u30fc\u30eb\u30dc\u30c3\u30af\u30b9\u306f\u306a\u3044\u3068\u3044\u3046\u3053\u3068\u3067\u3059\u3002\u5404\u4f01\u696d\u56fa\u6709\u306e\u8981\u4ef6\u306f\u3001\u30d5\u30a9\u30fc\u30de\u30c3\u30c8\u3067\u63d0\u4f9b\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002<\/p>\n<p><em>\u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u306e\u57fa\u672c\u7684\u306a\u30d5\u30a1\u30b7\u30ea\u30c6\u30fc\u30b7\u30e7\u30f3\u65b9\u6cd5 <\/em><\/p>\n<p>\u3053\u3053\u3067\u306f\u3001\u30c7\u30fc\u30bf\u3092\u6574\u7406\u3057\u3001\u610f\u601d\u6c7a\u5b9a\u3092\u5bb9\u6613\u306b\u3059\u308b\u3053\u3068\u3067\u3001\u30ea\u30b9\u30af\u7ba1\u7406\u3092\u69cb\u9020\u5316\u3059\u308b\u305f\u3081\u306b\u4e00\u822c\u7684\u306b\u7528\u3044\u3089\u308c\u308b\u30b7\u30f3\u30d7\u30eb\u306a\u624b\u6cd5\u3092\u7d39\u4ecb\u3057\u307e\u3059\u3002<\/p>\n<ul>\n<li>\u30d5\u30ed\u30fc\u30c1\u30e3\u30fc\u30c8<\/li>\n<li>\u30c1\u30a7\u30c3\u30af\u30b7\u30fc\u30c8<\/li>\n<li>\u30d7\u30ed\u30bb\u30b9\u30de\u30c3\u30d4\u30f3\u30b0<\/li>\n<li>\u539f\u56e0\u3068\u7d50\u679c\u306e\u30c0\u30a4\u30a2\u30b0\u30e9\u30e0\uff08\u77f3\u5ddd\u30c0\u30a4\u30a2\u30b0\u30e9\u30e0\u3001\u9b5a\u306e\u9aa8\u30c0\u30a4\u30a2\u30b0\u30e9\u30e0\u3068\u3082\u547c\u3070\u308c\u308b\uff09\u3002<\/li>\n<\/ul>\n<p><strong>__________<br \/>\n\u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30d7\u30e9\u30f3\u306e\u4f5c\u6210\u306b\u304a\u56f0\u308a\u3067\u3059\u304b\uff1f\u76f8\u8ac7\u3059\u308b <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/regulatory-writing?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=RMP\">\u85ac\u4e8b\u30a8\u30ad\u30b9\u30d1\u30fc\u30c8<\/a> \u305d\u3057\u3066 <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/medical-writing\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=RMP\">\u30e1\u30c7\u30a3\u30ab\u30eb\u30e9\u30a4\u30bf\u30fc<\/a> \u3092Kolabtree\u306b\u63b2\u8f09\u3057\u307e\u3057\u305f\u3002<\/strong><\/p>\n<p>&nbsp;<\/p>","protected":false},"excerpt":{"rendered":"<p>Nare Simonyan, freelance regulatory affairs specialist at Kolabtree, provides a comprehensive guide to preparing a Risk Management Plan (RMP). Abbreviations RMP &#8211; Risk Management Plan aPV &#8211; additional Pharmacovigilance eCTD &#8211; electronic Common Technical Document PSUR- Periodic Safety Update Report PASS &#8211; Post-Authorization Safety Studies PAES &#8211; Plans Post-authorization Efficacy Studies RA- Regulatory Authority QRMP &#8211; Quality Risk Management Process RMCs &#8211; Risk Management Committees MAA -Marketing Authorization Application ADR-Adverse Drug Reactions Purpose &amp; Scope of a Risk Management Plan A document summarizing the risks and pharmacovigilance\/risk minimization activities for a medicinal product with a well-established safety profile, used often to support a submission in a country\/region and when the<\/p>\n<div class=\"read-more\"><a href=\"https:\/\/www.kolabtree.com\/blog\/ja\/how-to-prepare-a-risk-management-plan-rmp-an-essential-guide\/\" title=\"\u7d9a\u304d\u3092\u8aad\u3080\">\u7d9a\u304d\u3092\u8aad\u3080<\/a><\/div>","protected":false},"author":12,"featured_media":9321,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[147],"tags":[],"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>How to prepare a Risk Management Plan (RMP): An essential guide<\/title>\n<meta name=\"description\" content=\"How to prepare a risk management plan (RMP), based on FDA and EU requirements, specific to the pharma and medical device markets.\" \/>\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\/how-to-prepare-a-risk-management-plan-rmp-an-essential-guide\/\" \/>\n<meta property=\"og:locale\" content=\"ja_JP\" 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