{"id":2815,"date":"2026-07-29T10:30:14","date_gmt":"2026-07-29T01:30:14","guid":{"rendered":"https:\/\/pharma.mynavi.jp\/knowhow\/?page_id=2815"},"modified":"2022-04-11T11:52:39","modified_gmt":"2022-04-11T02:52:39","slug":"regulatory-affairs","status":"publish","type":"page","link":"https:\/\/pharma.mynavi.jp\/knowhow\/workplace\/regulatory-affairs\/","title":{"rendered":"\u85ac\u4e8b\u7533\u8acb\u3068\u306f\uff1f\u696d\u52d9\u306e\u6d41\u308c\u3084RA\u306e\u4ed5\u4e8b\u5185\u5bb9\u30fb\u5e74\u53ce\u30fb\u5fc5\u8981\u306a\u8cc7\u683c\u3092\u7d39\u4ecb"},"content":{"rendered":"<h1><span class=\"ez-toc-section\" id=\"%E8%96%AC%E4%BA%8B%E7%94%B3%E8%AB%8B%E3%81%A8%E3%81%AF%EF%BC%9F%E6%A5%AD%E5%8B%99%E3%81%AE%E6%B5%81%E3%82%8C%E3%82%84RA%E3%81%AE%E4%BB%95%E4%BA%8B%E5%86%85%E5%AE%B9%E3%83%BB%E5%B9%B4%E5%8F%8E%E3%83%BB%E5%BF%85%E8%A6%81%E3%81%AA%E8%B3%87%E6%A0%BC%E3%82%92%E7%B4%B9%E4%BB%8B\"><\/span>\u85ac\u4e8b\u7533\u8acb\u3068\u306f\uff1f\u696d\u52d9\u306e\u6d41\u308c\u3084RA\u306e\u4ed5\u4e8b\u5185\u5bb9\u30fb\u5e74\u53ce\u30fb\u5fc5\u8981\u306a\u8cc7\u683c\u3092\u7d39\u4ecb<span class=\"ez-toc-section-end\"><\/span><\/h1>\n<p><img decoding=\"async\" loading=\"lazy\" class=\"alignnone size-full wp-image-2816\" src=\"https:\/\/pharma.mynavi.jp\/knowhow\/wp-content\/uploads\/2026\/07\/pixta_89049992_M.jpg\" alt=\"\u85ac\u4e8b\u7533\u8acb\u3068\u306f\uff1f\u696d\u52d9\u306e\u6d41\u308c\u3084RA\u306e\u4ed5\u4e8b\u5185\u5bb9\u30fb\u5e74\u53ce\u30fb\u5fc5\u8981\u306a\u8cc7\u683c\u3092\u7d39\u4ecb\" width=\"1024\" height=\"684\" 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id=\"ez-toc-container\" class=\"ez-toc-v2_0_51_1 counter-hierarchy ez-toc-counter ez-toc-container-direction\">\n<div class=\"ez-toc-title-container\">\n<p class=\"ez-toc-title \" >\u76ee\u6b21<\/p>\n<span class=\"ez-toc-title-toggle\"><\/span><\/div>\n<nav><ul class='ez-toc-list ez-toc-list-level-1 ' ><li class='ez-toc-page-1 ez-toc-heading-level-1'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/pharma.mynavi.jp\/knowhow\/workplace\/regulatory-affairs\/#%E8%96%AC%E4%BA%8B%E7%94%B3%E8%AB%8B%E3%81%A8%E3%81%AF%EF%BC%9F%E6%A5%AD%E5%8B%99%E3%81%AE%E6%B5%81%E3%82%8C%E3%82%84RA%E3%81%AE%E4%BB%95%E4%BA%8B%E5%86%85%E5%AE%B9%E3%83%BB%E5%B9%B4%E5%8F%8E%E3%83%BB%E5%BF%85%E8%A6%81%E3%81%AA%E8%B3%87%E6%A0%BC%E3%82%92%E7%B4%B9%E4%BB%8B\" title=\"\u85ac\u4e8b\u7533\u8acb\u3068\u306f\uff1f\u696d\u52d9\u306e\u6d41\u308c\u3084RA\u306e\u4ed5\u4e8b\u5185\u5bb9\u30fb\u5e74\u53ce\u30fb\u5fc5\u8981\u306a\u8cc7\u683c\u3092\u7d39\u4ecb\">\u85ac\u4e8b\u7533\u8acb\u3068\u306f\uff1f\u696d\u52d9\u306e\u6d41\u308c\u3084RA\u306e\u4ed5\u4e8b\u5185\u5bb9\u30fb\u5e74\u53ce\u30fb\u5fc5\u8981\u306a\u8cc7\u683c\u3092\u7d39\u4ecb<\/a><ul class='ez-toc-list-level-2'><li class='ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/pharma.mynavi.jp\/knowhow\/workplace\/regulatory-affairs\/#1_%E8%96%AC%E4%BA%8B%E7%94%B3%E8%AB%8B%E3%81%A8%E3%81%AF%EF%BC%9F\" title=\"1. \u85ac\u4e8b\u7533\u8acb\u3068\u306f\uff1f\">1. \u85ac\u4e8b\u7533\u8acb\u3068\u306f\uff1f<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/pharma.mynavi.jp\/knowhow\/workplace\/regulatory-affairs\/#2_%E8%96%AC%E4%BA%8B%E7%94%B3%E8%AB%8B%E3%81%AE%E6%B5%81%E3%82%8C%E3%81%A8%E6%A5%AD%E5%8B%99%E5%86%85%E5%AE%B9\" title=\"2. \u85ac\u4e8b\u7533\u8acb\u306e\u6d41\u308c\u3068\u696d\u52d9\u5185\u5bb9\">2. \u85ac\u4e8b\u7533\u8acb\u306e\u6d41\u308c\u3068\u696d\u52d9\u5185\u5bb9<\/a><ul class='ez-toc-list-level-3'><li class='ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/pharma.mynavi.jp\/knowhow\/workplace\/regulatory-affairs\/#2-1_PMDA%E3%81%AB%E7%94%B3%E8%AB%8B%E6%9B%B8%E9%A1%9E%E3%82%92%E6%8F%90%E5%87%BA%E3%81%99%E3%82%8B\" title=\"2-1. PMDA\u306b\u7533\u8acb\u66f8\u985e\u3092\u63d0\u51fa\u3059\u308b\">2-1. PMDA\u306b\u7533\u8acb\u66f8\u985e\u3092\u63d0\u51fa\u3059\u308b<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/pharma.mynavi.jp\/knowhow\/workplace\/regulatory-affairs\/#2-2_%E4%BF%A1%E9%A0%BC%E6%80%A7%E8%AA%BF%E6%9F%BB%E3%82%92%E5%8F%97%E3%81%91%E3%82%8B\" title=\"2-2. \u4fe1\u983c\u6027\u8abf\u67fb\u3092\u53d7\u3051\u308b\">2-2. \u4fe1\u983c\u6027\u8abf\u67fb\u3092\u53d7\u3051\u308b<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/pharma.mynavi.jp\/knowhow\/workplace\/regulatory-affairs\/#2-3_%E5%AF%A9%E6%9F%BB%E5%93%A1%E3%81%A8%E9%9D%A2%E8%AB%87%E3%82%92%E8%A1%8C%E3%81%86\" title=\"2-3. \u5be9\u67fb\u54e1\u3068\u9762\u8ac7\u3092\u884c\u3046\">2-3. \u5be9\u67fb\u54e1\u3068\u9762\u8ac7\u3092\u884c\u3046<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-7\" href=\"https:\/\/pharma.mynavi.jp\/knowhow\/workplace\/regulatory-affairs\/#2-4_%E8%A3%BD%E9%80%A0%E6%89%80%E3%81%AE%E9%81%A9%E5%90%88%E6%80%A7%E8%AA%BF%E6%9F%BB%E3%82%92%E5%8F%97%E3%81%91%E3%82%8B\" title=\"2-4. \u88fd\u9020\u6240\u306e\u9069\u5408\u6027\u8abf\u67fb\u3092\u53d7\u3051\u308b\">2-4. \u88fd\u9020\u6240\u306e\u9069\u5408\u6027\u8abf\u67fb\u3092\u53d7\u3051\u308b<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-8\" href=\"https:\/\/pharma.mynavi.jp\/knowhow\/workplace\/regulatory-affairs\/#2-5_%E5%8E%9A%E7%94%9F%E5%8A%B4%E5%83%8D%E5%A4%A7%E8%87%A3%E3%81%8B%E3%82%89%E8%A3%BD%E9%80%A0%E8%B2%A9%E5%A3%B2%E6%89%BF%E8%AA%8D%E3%82%92%E5%BE%97%E3%82%8B\" title=\"2-5. \u539a\u751f\u52b4\u50cd\u5927\u81e3\u304b\u3089\u88fd\u9020\u8ca9\u58f2\u627f\u8a8d\u3092\u5f97\u308b\">2-5. \u539a\u751f\u52b4\u50cd\u5927\u81e3\u304b\u3089\u88fd\u9020\u8ca9\u58f2\u627f\u8a8d\u3092\u5f97\u308b<\/a><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-9\" href=\"https:\/\/pharma.mynavi.jp\/knowhow\/workplace\/regulatory-affairs\/#3_%E8%96%AC%E4%BA%8B%E7%94%B3%E8%AB%8B%E6%A5%AD%E5%8B%99%E3%81%AB%E5%BF%85%E8%A6%81%E3%81%AA%E8%B3%87%E6%A0%BC%E3%83%BB%E3%82%B9%E3%82%AD%E3%83%AB\" title=\"3. \u85ac\u4e8b\u7533\u8acb\u696d\u52d9\u306b\u5fc5\u8981\u306a\u8cc7\u683c\u30fb\u30b9\u30ad\u30eb\">3. \u85ac\u4e8b\u7533\u8acb\u696d\u52d9\u306b\u5fc5\u8981\u306a\u8cc7\u683c\u30fb\u30b9\u30ad\u30eb<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-10\" href=\"https:\/\/pharma.mynavi.jp\/knowhow\/workplace\/regulatory-affairs\/#4_%E8%96%AC%E4%BA%8B%E7%94%B3%E8%AB%8B%E6%A5%AD%E5%8B%99%E3%81%AE%E3%83%A1%E3%83%AA%E3%83%83%E3%83%88%E3%81%A8%E3%82%84%E3%82%8A%E3%81%8C%E3%81%84\" title=\"4. \u85ac\u4e8b\u7533\u8acb\u696d\u52d9\u306e\u30e1\u30ea\u30c3\u30c8\u3068\u3084\u308a\u304c\u3044\">4. 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\u672a\u7d4c\u9a13\u304b\u3089\u85ac\u4e8b\u7533\u8acb\u62c5\u5f53\u8005\u306b\u306a\u308b\u306b\u306f\uff1f\">6. \u672a\u7d4c\u9a13\u304b\u3089\u85ac\u4e8b\u7533\u8acb\u62c5\u5f53\u8005\u306b\u306a\u308b\u306b\u306f\uff1f<\/a><ul class='ez-toc-list-level-3'><li class='ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-15\" href=\"https:\/\/pharma.mynavi.jp\/knowhow\/workplace\/regulatory-affairs\/#6-1_%E6%96%B0%E5%8D%92%E3%81%A7%E5%B0%B1%E8%81%B7%E3%81%99%E3%82%8B%E5%A0%B4%E5%90%88\" title=\"6-1. \u65b0\u5352\u3067\u5c31\u8077\u3059\u308b\u5834\u5408\">6-1. \u65b0\u5352\u3067\u5c31\u8077\u3059\u308b\u5834\u5408<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-16\" href=\"https:\/\/pharma.mynavi.jp\/knowhow\/workplace\/regulatory-affairs\/#6-2_%E8%BB%A2%E8%81%B7%E3%81%99%E3%82%8B%E5%A0%B4%E5%90%88\" title=\"6-2. \u8ee2\u8077\u3059\u308b\u5834\u5408\">6-2. \u8ee2\u8077\u3059\u308b\u5834\u5408<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-17\" href=\"https:\/\/pharma.mynavi.jp\/knowhow\/workplace\/regulatory-affairs\/#6-3_%E9%85%8D%E7%BD%AE%E8%BB%A2%E6%8F%9B%E3%82%92%E5%B8%8C%E6%9C%9B%E3%81%99%E3%82%8B%E5%A0%B4%E5%90%88\" title=\"6-3. \u914d\u7f6e\u8ee2\u63db\u3092\u5e0c\u671b\u3059\u308b\u5834\u5408\">6-3. \u914d\u7f6e\u8ee2\u63db\u3092\u5e0c\u671b\u3059\u308b\u5834\u5408<\/a><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-18\" href=\"https:\/\/pharma.mynavi.jp\/knowhow\/workplace\/regulatory-affairs\/#7_%E8%96%AC%E4%BA%8B%E7%94%B3%E8%AB%8B%E6%8B%85%E5%BD%93%E8%80%85%EF%BC%88RA%EF%BC%89%E3%81%AF%E8%96%AC%E5%89%A4%E5%B8%AB%E8%B3%87%E6%A0%BC%E3%82%92%E7%94%9F%E3%81%8B%E3%81%9B%E3%82%8B%E5%B0%82%E9%96%80%E8%81%B7%E3%81%AE%E4%B8%80%E3%81%A4\" title=\"7. \u85ac\u4e8b\u7533\u8acb\u62c5\u5f53\u8005\uff08RA\uff09\u306f\u85ac\u5264\u5e2b\u8cc7\u683c\u3092\u751f\u304b\u305b\u308b\u5c02\u9580\u8077\u306e\u4e00\u3064\">7. \u85ac\u4e8b\u7533\u8acb\u62c5\u5f53\u8005\uff08RA\uff09\u306f\u85ac\u5264\u5e2b\u8cc7\u683c\u3092\u751f\u304b\u305b\u308b\u5c02\u9580\u8077\u306e\u4e00\u3064<\/a><\/li><\/ul><\/li><\/ul><\/nav><\/div>\n\n<h2><span class=\"ez-toc-section\" id=\"1_%E8%96%AC%E4%BA%8B%E7%94%B3%E8%AB%8B%E3%81%A8%E3%81%AF%EF%BC%9F\"><\/span>1. \u85ac\u4e8b\u7533\u8acb\u3068\u306f\uff1f<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span class=\"bold\">\u85ac\u4e8b\u7533\u8acb\u3068\u306f\u3001\u533b\u7642\u7528\u533b\u85ac\u54c1\u3084\u4e00\u822c\u7528\u533b\u85ac\u54c1\u3001\u533b\u7642\u6a5f\u5668\u3001\u5316\u7ca7\u54c1\u306a\u3069\u3092\u88fd\u9020\u30fb\u8ca9\u58f2\u3059\u308b\u306b\u3042\u305f\u308a\u3001\u533b\u85ac\u54c1\u3001\u533b\u7642\u6a5f\u5668\u7b49\u306e\u54c1\u8cea\u3001\u6709\u52b9\u6027\u53ca\u3073\u5b89\u5168\u6027\u306e\u78ba\u4fdd\u7b49\u306b\u95a2\u3059\u308b\u6cd5\u5f8b\uff08\u4ee5\u4e0b\u3001\u85ac\u6a5f\u6cd5\uff09\u306b\u57fa\u3065\u3044\u3066\u539a\u751f\u52b4\u50cd\u5927\u81e3\u306e\u627f\u8a8d\u3092\u6c42\u3081\u308b\u696d\u52d9<\/span>\u3067\u3059\u3002<\/p>\n<p>\u533b\u85ac\u54c1\u3084\u533b\u7642\u6a5f\u5668\u306f\u4eba\u306e\u751f\u547d\u3084\u5065\u5eb7\u306b\u76f4\u63a5\u95a2\u308f\u308b\u88fd\u54c1\u3067\u3042\u308b\u305f\u3081\u3001\u6709\u52b9\u6027\u3084\u5b89\u5168\u6027\u3001\u54c1\u8cea\u3092\u56fd\u304c\u4e8b\u524d\u306b\u5be9\u67fb\u3057\u307e\u3059\u3002\u627f\u8a8d\u3092\u53d7\u3051\u3066\u521d\u3081\u3066\u3001\u88fd\u9020\u3084\u8ca9\u58f2\u3092\u884c\u3048\u308b\u4ed5\u7d44\u307f\u3067\u3059\u3002\u7533\u8acb\u306e\u7a2e\u985e\u3068\u3057\u3066\u3001\u65b0\u85ac\u306e\u627f\u8a8d\u7533\u8acb\u3001\u518d\u5be9\u67fb\u30fb\u518d\u8a55\u4fa1\u7533\u8acb\u3001\u533b\u7642\u6a5f\u5668\u306e\u627f\u8a8d\u30fb\u8a8d\u8a3c\u7533\u8acb\u306a\u3069\u304c\u6319\u3052\u3089\u308c\u307e\u3059\u3002<\/p>\n<p>\u7533\u8acb\u5bfe\u8c61\u306b\u3088\u3063\u3066\u63d0\u51fa\u3059\u308b\u66f8\u985e\u306f\u7570\u306a\u308a\u3001\u975e\u81e8\u5e8a\u8a66\u9a13\u3084\u81e8\u5e8a\u8a66\u9a13\uff08\u6cbb\u9a13\uff09\u3067\u5f97\u3089\u308c\u305f\u81a8\u5927\u306a\u30c7\u30fc\u30bf\u3092\u6574\u7406\u3057\u3066\u6dfb\u4ed8\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u624b\u7d9a\u304d\u306e\u591a\u3055\u3084\u8907\u96d1\u3055\u304b\u3089\u3001\u88fd\u85ac\u4f01\u696d\u3084\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u3067\u306f\u85ac\u4e8b\u7533\u8acb\u3092\u5c02\u9580\u306b\u62c5\u5f53\u3059\u308b\u8077\u7a2e\u3068\u3057\u3066\u3001\u85ac\u4e8b\u7533\u8acb\u62c5\u5f53\u8005\uff08RA\uff09\u3092\u8a2d\u7f6e\u3057\u3066\u3044\u308b\u5834\u5408\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n<div class=\"cv-contents-bottom cvictt\"><a href=\"\/entry2\/index.html\">\n  <div class=\"octagon\">\u7c21\u53581\u5206<\/div>\u7121\u6599\u8ee2\u8077\u30b5\u30dd\u30fc\u30c8\uff01\u3054\u767b\u9332\u306f\u3053\u3061\u3089<i class=\"fas fa-angle-right\"><\/i><\/a><\/div>\n\n<h2><span class=\"ez-toc-section\" id=\"2_%E8%96%AC%E4%BA%8B%E7%94%B3%E8%AB%8B%E3%81%AE%E6%B5%81%E3%82%8C%E3%81%A8%E6%A5%AD%E5%8B%99%E5%86%85%E5%AE%B9\"><\/span>2. \u85ac\u4e8b\u7533\u8acb\u306e\u6d41\u308c\u3068\u696d\u52d9\u5185\u5bb9<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\u85ac\u4e8b\u7533\u8acb\u306f\u3001\u7533\u8acb\u66f8\u985e\u306e\u63d0\u51fa\u304b\u3089\u627f\u8a8d\u53d6\u5f97\u307e\u3067\u306b\u8907\u6570\u306e\u6bb5\u968e\u304c\u3042\u308a\u307e\u3059\u3002\u3053\u3053\u304b\u3089\u306f\u3001\u85ac\u4e8b\u7533\u8acb\u306e\u4e3b\u306a\u6d41\u308c\u3084\u85ac\u4e8b\u7533\u8acb\u62c5\u5f53\u8005\uff08RA) \u306e\u5f79\u5272\u306b\u3064\u3044\u3066\u89e3\u8aac\u3057\u307e\u3059\u3002<\/p>\n<h3><span class=\"ez-toc-section\" id=\"2-1_PMDA%E3%81%AB%E7%94%B3%E8%AB%8B%E6%9B%B8%E9%A1%9E%E3%82%92%E6%8F%90%E5%87%BA%E3%81%99%E3%82%8B\"><\/span>2-1. PMDA\u306b\u7533\u8acb\u66f8\u985e\u3092\u63d0\u51fa\u3059\u308b<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><span class=\"bold\">\u85ac\u4e8b\u7533\u8acb\u306f\u3001\u7533\u8acb\u66f8\u985e\u3092PMDA\uff08\u533b\u85ac\u54c1\u533b\u7642\u6a5f\u5668\u7dcf\u5408\u6a5f\u69cb\uff09\u3078\u63d0\u51fa\u3059\u308b\u3068\u3053\u308d\u304b\u3089\u59cb\u307e\u308a\u307e\u3059<\/span>\u3002\u627f\u8a8d\u7533\u8acb\u66f8\u306b\u52a0\u3048\u3066\u3001CTD\uff08\u30b3\u30e2\u30f3\u30fb\u30c6\u30af\u30cb\u30ab\u30eb\u30fb\u30c9\u30ad\u30e5\u30e1\u30f3\u30c8\uff09\u3068\u547c\u3070\u308c\u308b\u56fd\u969b\u5171\u901a\u69d8\u5f0f\u3067\u4f5c\u6210\u3057\u305f\u6dfb\u4ed8\u8cc7\u6599\u3092\u63d0\u51fa\u3057\u307e\u3059\u3002\u7533\u8acb\u306e\u5b9b\u5148\u306f\u5236\u5ea6\u4e0a\u3001\u539a\u751f\u52b4\u50cd\u5927\u81e3\u3067\u3059\u304c\u3001\u5b9f\u969b\u306e\u53d7\u3051\u4ed8\u3051\u3084\u5be9\u67fb\u696d\u52d9\u3092\u53d6\u308a\u4ed5\u5207\u308b\u306e\u306f\u3001\u539a\u751f\u52b4\u50cd\u7701\u306e\u6240\u8f44\u6a5f\u95a2\u3067\u3042\u308bPMDA\u306b\u306a\u308a\u307e\u3059\u3002<\/p>\n<p><span class=\"bold\">\u7533\u8acb\u66f8\u985e\u306b\u306f\u3001\u88fd\u54c1\u306e\u6709\u52b9\u6027\u30fb\u5b89\u5168\u6027\u30fb\u54c1\u8cea\u3092\u5ba2\u89b3\u7684\u306b\u793a\u3059\u60c5\u5831\u3092\u8a18\u8f09<\/span>\u3057\u307e\u3059\u3002\u5177\u4f53\u7684\u306b\u306f\u3001\u958b\u767a\u306e\u80cc\u666f\u3084\u7d4c\u7def\u3001\u975e\u81e8\u5e8a\u8a66\u9a13\u304a\u3088\u3073\u81e8\u5e8a\u8a66\u9a13\u306e\u30c7\u30fc\u30bf\u3001\u54c1\u8cea\u3092\u4e00\u5b9a\u306b\u4fdd\u3064\u305f\u3081\u306e\u7ba1\u7406\u65b9\u6cd5\u3001\u52b9\u80fd\u52b9\u679c\u3084\u7528\u6cd5\u7528\u91cf\u306b\u95a2\u3059\u308b\u4e8b\u9805\u306a\u3069\u3067\u3059\u3002<\/p>\n<p>\u85ac\u4e8b\u7533\u8acb\u62c5\u5f53\u8005\uff08RA\uff09\u306f\u3001\u7814\u7a76\u30fb\u81e8\u5e8a\u958b\u767a\u306a\u3069\u793e\u5185\u306e\u5404\u90e8\u9580\u304b\u3089\u60c5\u5831\u3092\u96c6\u7d04\u3057\u3001\u6574\u5408\u6027\u306e\u53d6\u308c\u305f\u7533\u8acb\u66f8\u985e\u3092\u4f5c\u6210\u3059\u308b\u5f79\u5272\u3092\u62c5\u3044\u307e\u3059\u3002<\/p>\n<h3><span class=\"ez-toc-section\" id=\"2-2_%E4%BF%A1%E9%A0%BC%E6%80%A7%E8%AA%BF%E6%9F%BB%E3%82%92%E5%8F%97%E3%81%91%E3%82%8B\"><\/span>2-2. \u4fe1\u983c\u6027\u8abf\u67fb\u3092\u53d7\u3051\u308b<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><span class=\"bold\">\u85ac\u7533\u8acb\u66f8\u985e\u304c\u53d7\u7406\u3055\u308c\u308b\u3068\u3001PMDA\u306b\u3088\u308b\u4fe1\u983c\u6027\u8abf\u67fb\u304c\u5b9f\u65bd<\/span>\u3055\u308c\u307e\u3059\u3002\u4fe1\u983c\u6027\u8abf\u67fb\u3068\u306f\u3001\u7533\u8acb\u8cc7\u6599\u306b\u6dfb\u4ed8\u3055\u308c\u305f\u30c7\u30fc\u30bf\u304c\u3001\u533b\u85ac\u54c1\u306e\u81e8\u5e8a\u8a66\u9a13\u306e\u5b9f\u65bd\u306e\u57fa\u6e96(GCP\u7701\u4ee4)\u3084\u533b\u85ac\u54c1\u306e\u5b89\u5168\u6027\u306b\u95a2\u3059\u308b\u975e\u81e8\u5e8a\u8a66\u9a13\u306e\u5b9f\u65bd\u306e\u57fa\u6e96(GLP\u7701\u4ee4)\u306a\u3069\u306b\u6cbf\u3063\u3066\u9069\u6b63\u306b\u53ce\u96c6\u30fb\u4f5c\u6210\u3055\u308c\u3066\u3044\u308b\u304b\u3092\u691c\u8a3c\u3059\u308b\u3082\u306e\u3067\u3059\u3002<\/p>\n<p>\u4fe1\u983c\u6027\u8abf\u67fb\u3067\u306f\u3001\u66f8\u9762\u8abf\u67fb\u3084\u5b9f\u5730\u8abf\u67fb\u304c\u884c\u308f\u308c\u307e\u3059\u3002\u66f8\u9762\u8abf\u67fb\u3067\u306f\u3001\u7533\u8acb\u8cc7\u6599\u306e\u6b63\u78ba\u6027\u3084\u6839\u62e0\u3068\u306a\u308b\u8cc7\u6599\u306e\u4fdd\u5b58\u72b6\u6cc1\u306a\u3069\u304c\u70b9\u691c\u3055\u308c\u307e\u3059\u3002\u5b9f\u5730\u8abf\u67fb\u306f\u3001\u6cbb\u9a13\u3092\u5b9f\u65bd\u3057\u305f\u533b\u7642\u6a5f\u95a2\u3084\u30c7\u30fc\u30bf\u7ba1\u7406\u3092\u62c5\u3063\u305f\u65bd\u8a2d\u304c\u5bfe\u8c61\u3067\u3059\u3002<span class=\"bold\">\u85ac\u6cbb\u9a13\u304c\u8a08\u753b\u66f8\u3069\u304a\u308a\u306b\u5b9f\u65bd\u3055\u308c\u3066\u3044\u308b\u304b\u3001\u6709\u52b9\u6027\u30fb\u5b89\u5168\u6027\u306e\u8a55\u4fa1\u306b\u5f71\u97ff\u3092\u53ca\u307c\u3059\u4e8b\u8c61\u304c\u306a\u304b\u3063\u305f\u304b\u306a\u3069\u304c\u78ba\u8a8d<\/span>\u3055\u308c\u307e\u3059\u3002<\/p>\n<h3><span class=\"ez-toc-section\" id=\"2-3_%E5%AF%A9%E6%9F%BB%E5%93%A1%E3%81%A8%E9%9D%A2%E8%AB%87%E3%82%92%E8%A1%8C%E3%81%86\"><\/span>2-3. \u5be9\u67fb\u54e1\u3068\u9762\u8ac7\u3092\u884c\u3046<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><span class=\"bold\">\u66f8\u985e\u5be9\u67fb\u3068\u4e26\u884c\u3057\u3066\u3001PMDA\u306e\u5be9\u67fb\u30c1\u30fc\u30e0\u3068\u7533\u8acb\u4f01\u696d\u3068\u306e\u9593\u3067\u9762\u8ac7\u304c\u884c\u308f\u308c\u307e\u3059<\/span>\u3002\u5be9\u67fb\u306e\u904e\u7a0b\u3067\u7591\u554f\u70b9\u304c\u751f\u3058\u305f\u5834\u5408\u3001PMDA\u304b\u3089\u7167\u4f1a\u4e8b\u9805\u304c\u767a\u51fa\u3055\u308c\u307e\u3059\u3002\u7533\u8acb\u4f01\u696d\u306f\u79d1\u5b66\u7684\u6839\u62e0\u306b\u57fa\u3065\u3044\u305f\u56de\u7b54\u66f8\u3092\u4f5c\u6210\u3057\u3001\u8aac\u660e\u3057\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002<\/p>\n<p>RA\u306f\u7167\u4f1a\u4e8b\u9805\u3078\u306e\u56de\u7b54\u66f8\u3092\u4f5c\u6210\u3057\u307e\u3059\u3002\u793e\u5185\u306e\u95a2\u4fc2\u90e8\u7f72\u3068\u8ad6\u70b9\u3092\u6574\u7406\u3057\u305f\u4e0a\u3067\u9762\u8ac7\u306b\u81e8\u307f\u3001\u4f01\u696d\u5074\u306e\u7a93\u53e3\u3068\u3057\u3066\u5bfe\u5fdc\u3057\u307e\u3059\u3002\u5be9\u67fb\u3092\u5186\u6ed1\u306b\u9032\u3081\u308b\u305f\u3081\u306b\u306f\u3001\u7167\u4f1a\u4e8b\u9805\u306e\u610f\u56f3\u3092\u6b63\u78ba\u306b\u8aad\u307f\u53d6\u308a\u3001\u6839\u62e0\u3068\u306a\u308b\u8cc7\u6599\u3092\u305d\u308d\u3048\u3066\u8ad6\u7406\u7684\u306a\u56de\u7b54\u3092\u6e96\u5099\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n<p>\u53c2\u8003\uff1a<a href=\"https:\/\/www.pmda.go.jp\/files\/000273976.pdf\" target=\"_blank\" rel=\"noopener\">\u4fe1\u983c\u6027\u8abf\u67fb\u306b\u3064\u3044\u3066\uff5c\u533b\u85ac\u54c1\u533b\u7642\u6a5f\u5668\u7dcf\u5408\u6a5f\u69cb<\/a><\/p>\n<h3><span class=\"ez-toc-section\" id=\"2-4_%E8%A3%BD%E9%80%A0%E6%89%80%E3%81%AE%E9%81%A9%E5%90%88%E6%80%A7%E8%AA%BF%E6%9F%BB%E3%82%92%E5%8F%97%E3%81%91%E3%82%8B\"><\/span>2-4. \u88fd\u9020\u6240\u306e\u9069\u5408\u6027\u8abf\u67fb\u3092\u53d7\u3051\u308b<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><span class=\"bold\">\u7533\u8acb\u66f8\u985e\u306e\u5be9\u67fb\u306b\u52a0\u3048\u3066\u3001\u88fd\u9020\u6240\u306e\u9069\u5408\u6027\u8abf\u67fb\u3082\u884c\u308f\u308c\u307e\u3059\u3002\u627f\u8a8d\u3069\u304a\u308a\u306b\u88fd\u54c1\u3092\u7d99\u7d9a\u88fd\u9020\u3067\u304d\u308b\u4f53\u5236\u304c\u6574\u3063\u3066\u3044\u308b\u304b\u3092\u691c\u8a3c\u3059\u308b\u8abf\u67fb<\/span>\u3067\u3059\u3002\u8abf\u67fb\u306e\u6839\u62e0\u3068\u306a\u308b\u7701\u4ee4\u306f\u3001\u88fd\u54c1\u306e\u7a2e\u985e\u306b\u3088\u3063\u3066\u4ee5\u4e0b\u306e\u3088\u3046\u306b\u5b9a\u3081\u3089\u308c\u3066\u3044\u307e\u3059\u3002<\/p>\n<ul class=\"type1\">\n<li>GMP\u7701\u4ee4(\u533b\u85ac\u54c1\u53ca\u3073\u533b\u85ac\u90e8\u5916\u54c1\u306e\u88fd\u9020\u7ba1\u7406\u53ca\u3073\u54c1\u8cea\u7ba1\u7406\u306e\u57fa\u6e96\u306b\u95a2\u3059\u308b\u7701\u4ee4)<\/li>\n<li>QMS\u7701\u4ee4(\u533b\u7642\u6a5f\u5668\u53ca\u3073\u4f53\u5916\u8a3a\u65ad\u7528\u533b\u85ac\u54c1\u306e\u88fd\u9020\u7ba1\u7406\u53ca\u3073\u54c1\u8cea\u7ba1\u7406\u306e\u57fa\u6e96\u306b\u95a2\u3059\u308b\u7701\u4ee4)<\/li>\n<li>GCTP\u7701\u4ee4(\u518d\u751f\u533b\u7642\u7b49\u88fd\u54c1\u306e\u88fd\u9020\u7ba1\u7406\u53ca\u3073\u54c1\u8cea\u7ba1\u7406\u306e\u57fa\u6e96\u306b\u95a2\u3059\u308b\u7701\u4ee4)<\/li>\n<\/ul>\n<p>\u3053\u308c\u3089\u306e\u8abf\u67fb\u306f\u7533\u8acb\u66f8\u985e\u306e\u8a18\u8f09\u5185\u5bb9\u3060\u3051\u3067\u5224\u65ad\u305b\u305a\u3001\u88fd\u9020\u5de5\u7a0b\u3084\u54c1\u8cea\u7ba1\u7406\u306e\u5b9f\u614b\u3092\u78ba\u304b\u3081\u308b\u4ed5\u7d44\u307f\u3067\u3059\u3002<\/p>\n<p>\u53c2\u8003\uff1a<a href=\"https:\/\/www.pmda.go.jp\/review-services\/gmp-qms-gctp\/0001.html\" target=\"_blank\" rel=\"noopener\">GMP\/QMS\/GCTP\u9069\u5408\u6027\u8abf\u67fb\u696d\u52d9\uff5c\u533b\u85ac\u54c1\u533b\u7642\u6a5f\u5668\u7dcf\u5408\u6a5f\u69cb<\/a><\/p>\n<h3><span class=\"ez-toc-section\" id=\"2-5_%E5%8E%9A%E7%94%9F%E5%8A%B4%E5%83%8D%E5%A4%A7%E8%87%A3%E3%81%8B%E3%82%89%E8%A3%BD%E9%80%A0%E8%B2%A9%E5%A3%B2%E6%89%BF%E8%AA%8D%E3%82%92%E5%BE%97%E3%82%8B\"><\/span>2-5. \u539a\u751f\u52b4\u50cd\u5927\u81e3\u304b\u3089\u88fd\u9020\u8ca9\u58f2\u627f\u8a8d\u3092\u5f97\u308b<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><span class=\"bold\">PMDA\u3067\u306e\u5be9\u67fb\u3068\u8abf\u67fb\u304c\u4e00\u901a\u308a\u5b8c\u4e86\u3059\u308b\u3068\u3001\u5be9\u67fb\u7d50\u679c\u3092\u307e\u3068\u3081\u305f\u5831\u544a\u66f8\u304c\u539a\u751f\u52b4\u50cd\u7701\u306b\u63d0\u51fa<\/span>\u3055\u308c\u307e\u3059\u3002\u305d\u306e\u5f8c\u3001\u85ac\u4e8b\u5be9\u8b70\u4f1a\uff08\u65e7\u30fb\u85ac\u4e8b\u30fb\u98df\u54c1\u885b\u751f\u5be9\u8b70\u4f1a\uff09\u306e\u5be9\u8b70\u306b\u304b\u3051\u3089\u308c\u3001\u7b54\u7533\u3092\u3082\u3068\u306b\u539a\u751f\u52b4\u50cd\u5927\u81e3\u304c\u88fd\u9020\u8ca9\u58f2\u3092\u627f\u8a8d\u3059\u308b\u6d41\u308c\u3067\u3059\u3002<\/p>\n<p>\u627f\u8a8d\u307e\u3067\u306b\u8981\u3059\u308b\u671f\u9593\u306f\u3001\u54c1\u76ee\u306b\u3088\u3063\u3066\u5dee\u304c\u3042\u308a\u307e\u3059\u3002\u77ed\u3044\u30b1\u30fc\u30b9\u3067\u3082\u534a\u5e74\u307b\u3069\u304b\u304b\u308a\u3001\u65b0\u85ac\u306e\u5834\u5408\u306f1\u5e74\u7a0b\u5ea6\u3092\u898b\u8fbc\u3080\u306e\u304c\u4e00\u822c\u7684\u3060\u3068\u3055\u308c\u3066\u3044\u307e\u3059\u3002<\/p>\n<p>\u53c2\u8003\uff1a<a href=\"https:\/\/www.pmda.go.jp\/files\/000263354.pdf\" target=\"_blank\" rel=\"noopener\">\u85ac\u5264\u627f\u8a8d\u306e\u4ed5\u7d44\u307f\u306b\u3064\u3044\u3066\uff5e\u5b89\u5fc3\u3067\u52b9\u679c\u7684\u306a\u85ac\u5264\u3092\u5c4a\u3051\u308b\u305f\u3081\u306b\uff5e\uff5c\u533b\u85ac\u54c1\u533b\u7642\u6a5f\u5668\u7dcf\u5408\u6a5f\u69cb<\/a><\/p>\n<h2><span class=\"ez-toc-section\" id=\"3_%E8%96%AC%E4%BA%8B%E7%94%B3%E8%AB%8B%E6%A5%AD%E5%8B%99%E3%81%AB%E5%BF%85%E8%A6%81%E3%81%AA%E8%B3%87%E6%A0%BC%E3%83%BB%E3%82%B9%E3%82%AD%E3%83%AB\"><\/span>3. \u85ac\u4e8b\u7533\u8acb\u696d\u52d9\u306b\u5fc5\u8981\u306a\u8cc7\u683c\u30fb\u30b9\u30ad\u30eb<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span class=\"bold\">\u85ac\u4e8b\u7533\u8acb\u62c5\u5f53\u8005\uff08RA)\u306b\u306a\u308b\u305f\u3081\u306e\u5fc5\u9808\u8cc7\u683c\u306f\u3042\u308a\u307e\u305b\u3093<\/span>\u3002\u305f\u3060\u3057\u3001\u696d\u52d9\u3092\u9042\u884c\u3059\u308b\u3046\u3048\u3067\u306f\u3001\u533b\u85ac\u54c1\u3084\u5bfe\u8c61\u75be\u60a3\u306b\u5bfe\u3059\u308b\u6df1\u3044\u77e5\u8b58\u304c\u5fc5\u8981\u3067\u3059\u3002\u52a0\u3048\u3066\u3001\u81e8\u5e8a\u8a66\u9a13\u3067\u5f97\u3089\u308c\u305f\u30c7\u30fc\u30bf\u3092\u8aad\u307f\u89e3\u304d\u3001\u7533\u8acb\u66f8\u985e\u306b\u9069\u5207\u306a\u5f62\u3067\u843d\u3068\u3057\u8fbc\u3080\u529b\u3082\u6c42\u3081\u3089\u308c\u307e\u3059\u3002\u3053\u3046\u3057\u305f\u7406\u7531\u304b\u3089\u3001\u85ac\u5264\u5e2b\u8cc7\u683c\u3092\u6301\u3063\u3066\u3044\u308b\u3068\u3001\u63a1\u7528\u306e\u5834\u9762\u3084\u5b9f\u52d9\u3067\u6709\u5229\u306b\u50cd\u304f\u5834\u5408\u304c\u3042\u308b\u3067\u3057\u3087\u3046\u3002<\/p>\n<p>\u307e\u305f\u3001<span class=\"bold\">\u66f8\u985e\u4f5c\u6210\u304c\u696d\u52d9\u306e\u4e2d\u5fc3\u3068\u306a\u308b\u305f\u3081\u3001Word\u3084Excel\u3001PowerPoint\u3092\u6271\u3046\u57fa\u672c\u7684\u306aPC\u30b9\u30ad\u30eb<\/span>\u304c\u6b20\u304b\u305b\u307e\u305b\u3093\u3002\u793e\u5185\u5916\u306e\u95a2\u4fc2\u8005\u3068\u9023\u643a\u3059\u308b\u5834\u9762\u304c\u3042\u308b\u305f\u3081\u3001\u30b3\u30df\u30e5\u30cb\u30b1\u30fc\u30b7\u30e7\u30f3\u80fd\u529b\u3082\u6c42\u3081\u3089\u308c\u308b\u3067\u3057\u3087\u3046\u3002<\/p>\n<p>\u52a0\u3048\u3066\u3001<span class=\"bold\">\u82f1\u8a9e\u529b\u3082\u8eab\u306b\u4ed8\u3051\u3066\u304a\u304f\u5fc5\u8981<\/span>\u304c\u3042\u308a\u307e\u3059\u3002\u82f1\u8a9e\u306e\u6587\u732e\u304b\u3089\u77e5\u8b58\u3092\u5f97\u305f\u308a\u3001\u82f1\u8a9e\u3067\u66f8\u985e\u3092\u4f5c\u6210\u3057\u305f\u308a\u3059\u308b\u6a5f\u4f1a\u304c\u3042\u308b\u305f\u3081\u3067\u3059\u3002\u4f01\u696d\u306b\u3088\u3063\u3066\u7570\u306a\u308a\u307e\u3059\u304c\u3001TOEIC600\u70b9\u4ee5\u4e0a\u304c\u76ee\u5b89\u3067\u3059\u3002<\/p>\n<h2><span class=\"ez-toc-section\" id=\"4_%E8%96%AC%E4%BA%8B%E7%94%B3%E8%AB%8B%E6%A5%AD%E5%8B%99%E3%81%AE%E3%83%A1%E3%83%AA%E3%83%83%E3%83%88%E3%81%A8%E3%82%84%E3%82%8A%E3%81%8C%E3%81%84\"><\/span>4. \u85ac\u4e8b\u7533\u8acb\u696d\u52d9\u306e\u30e1\u30ea\u30c3\u30c8\u3068\u3084\u308a\u304c\u3044<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\u85ac\u4e8b\u7533\u8acb\u696d\u52d9\u306e\u9b45\u529b\u306f\u3001\u5c02\u9580\u6027\u304c\u8a55\u4fa1\u3055\u308c\u308b\u30ad\u30e3\u30ea\u30a2\u9762\u306e\u30e1\u30ea\u30c3\u30c8\u3068\u3001\u696d\u52d9\u305d\u306e\u3082\u306e\u304b\u3089\u5f97\u3089\u308c\u308b\u3084\u308a\u304c\u3044\u3067\u3059\u3002\u3053\u3053\u304b\u3089\u306f\u3001\u85ac\u4e8b\u7533\u8acb\u696d\u52d9\u306e\u30e1\u30ea\u30c3\u30c8\u3068\u3084\u308a\u304c\u3044\u306b\u3064\u3044\u3066\u89e3\u8aac\u3057\u307e\u3059\u3002<\/p>\n<h3><span class=\"ez-toc-section\" id=\"4-1_%E8%96%AC%E4%BA%8B%E7%94%B3%E8%AB%8B%E6%A5%AD%E5%8B%99%E3%81%AE%E3%83%A1%E3%83%AA%E3%83%83%E3%83%88\"><\/span>4-1. \u85ac\u4e8b\u7533\u8acb\u696d\u52d9\u306e\u30e1\u30ea\u30c3\u30c8<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><span class=\"bold\">\u85ac\u4e8b\u7533\u8acb\u62c5\u5f53\u8005\uff08RA\uff09\u306f\u3001\u7d4c\u9a13\u3092\u7a4d\u3080\u307b\u3069\u8a55\u4fa1\u304c\u9ad8\u307e\u308a\u3084\u3059\u3044\u8077\u7a2e<\/span>\u3068\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u9577\u671f\u7684\u306b\u5b89\u5b9a\u3057\u305f\u96c7\u7528\u304c\u898b\u8fbc\u3081\u308b\u3046\u3048\u3001\u5c02\u9580\u6027\u3092\u78e8\u3051\u3070\u8ee2\u8077\u5e02\u5834\u3067\u3082\u512a\u4f4d\u306b\u7acb\u3066\u308b\u3067\u3057\u3087\u3046\u3002<\/p>\n<p>\u30ad\u30e3\u30ea\u30a2\u306e\u65b9\u5411\u6027\u306f\u3001\u4f01\u696d\u306e\u898f\u6a21\u306b\u3088\u3063\u3066\u7570\u306a\u308b\u3053\u3068\u304c\u3042\u308a\u307e\u3059\u3002\u4e2d\u5c0f\u4f01\u696d\u3067\u306f\u3001\u5e45\u5e83\u3044\u5206\u91ce\u3067\u7533\u8acb\u696d\u52d9\u306b\u643a\u308f\u308b\u306e\u304c\u4e00\u822c\u7684\u3067\u3059\u3002\u793e\u54e1\u6570\u304c\u9650\u3089\u308c\u3066\u3044\u308b\u5206\u3001\u30ad\u30e3\u30ea\u30a2\u306e\u521d\u671f\u304b\u3089\u88c1\u91cf\u306e\u3042\u308b\u4ed5\u4e8b\u3092\u4efb\u3055\u308c\u3084\u3059\u3044\u74b0\u5883\u3067\u3059\u3002\u7d4c\u9a13\u3092\u65e9\u304f\u7a4d\u3081\u308b\u305f\u3081\u3001\u7ba1\u7406\u8077\u3078\u306e\u30ad\u30e3\u30ea\u30a2\u30a2\u30c3\u30d7\u3082\u671f\u5f85\u3067\u304d\u308b\u3067\u3057\u3087\u3046\u3002<\/p>\n<p>\u5927\u624b\u4f01\u696d\u3067\u306f\u3001\u7279\u5b9a\u306e\u88fd\u54c1\u5206\u91ce\u3084\u6cbb\u7642\u9818\u57df\u3092\u5c02\u9580\u306b\u62c5\u5f53\u3059\u308b\u30b1\u30fc\u30b9\u304c\u4e2d\u5fc3\u3067\u3059\u3002\u7279\u5b9a\u9818\u57df\u3092\u6df1\u304f\u6398\u308a\u4e0b\u3052\u305f\u85ac\u4e8b\u62c5\u5f53\u8005\u306f\u3001\u4ed6\u793e\u304b\u3089\u306e\u30cb\u30fc\u30ba\u3082\u9ad8\u304f\u3001\u8ee2\u8077\u5e02\u5834\u3067\u8a55\u4fa1\u3055\u308c\u308b\u50be\u5411\u306b\u3042\u308a\u307e\u3059\u3002<\/p>\n<h3><span class=\"ez-toc-section\" id=\"4-2_%E8%96%AC%E4%BA%8B%E7%94%B3%E8%AB%8B%E6%A5%AD%E5%8B%99%E3%81%AE%E3%82%84%E3%82%8A%E3%81%8C%E3%81%84\"><\/span>4-2. \u85ac\u4e8b\u7533\u8acb\u696d\u52d9\u306e\u3084\u308a\u304c\u3044<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><span class=\"bold\">\u85ac\u4e8b\u7533\u8acb\u306e\u3084\u308a\u304c\u3044\u306f\u3001\u533b\u85ac\u54c1\u3084\u533b\u7642\u6a5f\u5668\u304c\u60a3\u8005\u3055\u3093\u306e\u3082\u3068\u3078\u5c4a\u304f\u3068\u3044\u3046\u6210\u679c\u3092\u5b9f\u611f\u3067\u304d\u308b\u3053\u3068<\/span>\u3067\u3059\u3002<\/p>\n<h2><span class=\"ez-toc-section\" id=\"5_%E8%96%AC%E4%BA%8B%E7%94%B3%E8%AB%8B%E6%8B%85%E5%BD%93%E8%80%85%EF%BC%88RA%EF%BC%89%E3%81%AE%E5%B9%B4%E5%8F%8E\"><\/span>5. \u85ac\u4e8b\u7533\u8acb\u62c5\u5f53\u8005\uff08RA\uff09\u306e\u5e74\u53ce<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\u85ac\u4e8b\u7533\u8acb\u62c5\u5f53\u8005\uff08RA\uff09\u306e\u5e74\u53ce\u306b\u3064\u3044\u3066\u3001\u516c\u7684\u306a\u7d71\u8a08\u30c7\u30fc\u30bf\u306f\u516c\u8868\u3055\u308c\u3066\u3044\u307e\u305b\u3093\u3002<span class=\"bold\">\u53c2\u8003\u3068\u3057\u3066\u3001\u540c\u3058\u88fd\u85ac\u696d\u754c\u3067\u50cd\u304f\u4ed6\u8077\u7a2e\u306e\u5e73\u5747\u5e74\u53ce\u3092\u4ee5\u4e0b\u306b\u7d39\u4ecb<\/span>\u3057\u307e\u3059\u3002\u6570\u5024\u306f\u3001\u4ee4\u548c7\u5e74\u8cc3\u91d1\u69cb\u9020\u57fa\u672c\u7d71\u8a08\u8abf\u67fb\u306e\u7d50\u679c\u3092\u3082\u3068\u306b\u3001\u539a\u751f\u52b4\u50cd\u7701\u300c\u8077\u696d\u60c5\u5831\u63d0\u4f9b\u30b5\u30a4\u30c8 job tag\u300d\u304c\u516c\u8868\u3057\u3066\u3044\u308b\u3082\u306e\u3067\u3059\u3002<\/p>\n<table class=\"type2\">\n<tr>\n<th>\u8077\u7a2e<\/th>\n<th>\u5e73\u5747\u5e74\u53ce<\/th>\n<\/tr>\n<tr>\n<td>\u533b\u85ac\u60c5\u5831\u62c5\u5f53\u8005\uff08MR\uff09<\/td>\n<td>660\u4e077\u5343\u5186<\/td>\n<\/tr>\n<tr>\n<td>\u81e8\u5e8a\u958b\u767a\u30e2\u30cb\u30bf\u30fc\uff08CRA\uff09<\/td>\n<td>528\u4e077\u5343\u5186<\/td>\n<\/tr>\n<tr>\n<td>\u85ac\u5b66\u7814\u7a76\u8005<\/td>\n<td>802\u4e07\u5186<\/td>\n<\/tr>\n<\/table>\n<p>\u306a\u304a\u3001\u3053\u308c\u3089\u306e\u5e74\u53ce\u306f\u3001\u4f01\u696d\u306e\u898f\u6a21\u3084\u5916\u8cc7\u7cfb\u30fb\u5185\u8cc7\u7cfb\u3068\u3044\u3063\u305f\u52e4\u52d9\u5148\u306e\u5c5e\u6027\u3001\u696d\u52d9\u5185\u5bb9\u3001\u7d4c\u9a13\u30fb\u30b9\u30ad\u30eb\u306a\u3069\u306b\u3088\u3063\u3066\u5909\u52d5\u3059\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n<p>\u53c2\u8003\uff1a<a href=\"https:\/\/shigoto.mhlw.go.jp\/User\/Occupation\/Detail\/63\" target=\"_blank\" rel=\"noopener\">\u533b\u85ac\u60c5\u5831\u62c5\u5f53\u8005\uff08MR\uff09\uff5c\u8077\u696d\u60c5\u5831\u63d0\u4f9b\u30b5\u30a4\u30c8 job tag<\/a><br \/>\n\u53c2\u8003\uff1a<a href=\"https:\/\/shigoto.mhlw.go.jp\/User\/Occupation\/Detail\/530\" target=\"_blank\" rel=\"noopener\">\u81e8\u5e8a\u958b\u767a\u30e2\u30cb\u30bf\u30fc\uff5c\u8077\u696d\u60c5\u5831\u63d0\u4f9b\u30b5\u30a4\u30c8 job tag<\/a><br \/>\n\u53c2\u8003\uff1a<a href=\"https:\/\/shigoto.mhlw.go.jp\/User\/Occupation\/Detail\/392\" target=\"_blank\" rel=\"noopener\">\u85ac\u5b66\u7814\u7a76\u8005\uff5c\u8077\u696d\u60c5\u5831\u63d0\u4f9b\u30b5\u30a4\u30c8 job tag<\/a><\/p>\n<h2><span class=\"ez-toc-section\" id=\"6_%E6%9C%AA%E7%B5%8C%E9%A8%93%E3%81%8B%E3%82%89%E8%96%AC%E4%BA%8B%E7%94%B3%E8%AB%8B%E6%8B%85%E5%BD%93%E8%80%85%E3%81%AB%E3%81%AA%E3%82%8B%E3%81%AB%E3%81%AF%EF%BC%9F\"><\/span>6. \u672a\u7d4c\u9a13\u304b\u3089\u85ac\u4e8b\u7533\u8acb\u62c5\u5f53\u8005\u306b\u306a\u308b\u306b\u306f\uff1f<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\u85ac\u4e8b\u7533\u8acb\u62c5\u5f53\u8005(RA)\u306f\u696d\u52d9\u306e\u5c02\u9580\u6027\u304c\u9ad8\u304f\u3001\u5373\u6226\u529b\u3068\u306a\u308b\u4eba\u6750\u304c\u6c42\u3081\u3089\u308c\u307e\u3059\u3002\u305d\u306e\u305f\u3081\u3001\u672a\u7d4c\u9a13\u304b\u3089\u76ee\u6307\u3059\u306b\u306f\u76f8\u5fdc\u306e\u6e96\u5099\u304c\u5fc5\u8981\u3067\u3059\u3002\u3053\u3053\u304b\u3089\u306f\u3001\u65b0\u5352\u3067\u5c31\u8077\u3059\u308b\u5834\u5408\u3001\u8ee2\u8077\u3059\u308b\u5834\u5408\u3001\u914d\u7f6e\u8ee2\u63db\u3092\u5e0c\u671b\u3059\u308b\u5834\u5408\u4e09\u3064\u306b\u5206\u3051\u3066\u3001\u305d\u308c\u305e\u308c\u306e\u30a2\u30d7\u30ed\u30fc\u30c1\u3092\u7d39\u4ecb\u3057\u307e\u3059\u3002<\/p>\n<h3><span class=\"ez-toc-section\" id=\"6-1_%E6%96%B0%E5%8D%92%E3%81%A7%E5%B0%B1%E8%81%B7%E3%81%99%E3%82%8B%E5%A0%B4%E5%90%88\"><\/span>6-1. \u65b0\u5352\u3067\u5c31\u8077\u3059\u308b\u5834\u5408<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><span class=\"bold\">\u65b0\u5352\u63a1\u7528\u3067\u3001\u6700\u521d\u304b\u3089\u85ac\u4e8b\u90e8\u9580\u3078\u914d\u5c5e\u3055\u308c\u308b\u30b1\u30fc\u30b9\u306f\u591a\u304f\u3042\u308a\u307e\u305b\u3093<\/span>\u3002RA\u306b\u306f\u6cd5\u4ee4\u3084\u81e8\u5e8a\u958b\u767a\u306b\u95a2\u3059\u308b\u5b9f\u52d9\u77e5\u8b58\u304c\u6c42\u3081\u3089\u308c\u308b\u305f\u3081\u3001\u4e2d\u9014\u63a1\u7528\u306b\u3088\u308a\u5373\u6226\u529b\u3068\u306a\u308b\u4eba\u6750\u3092\u78ba\u4fdd\u3059\u308b\u50be\u5411\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n<p>\u65b0\u5352\u304b\u3089\u85ac\u4e8b\u8077\u3092\u76ee\u6307\u3059\u5834\u5408\u306f\u3001\u307e\u305a\u81e8\u5e8a\u958b\u767a\u3084\u7814\u7a76\u958b\u767a\u90e8\u9580\u3067\u7d4c\u9a13\u3092\u7a4d\u307f\u3001\u305d\u306e\u5f8c\u3001\u793e\u5185\u7570\u52d5\u3067\u85ac\u4e8b\u90e8\u9580\u306b\u79fb\u308b\u65b9\u6cd5\u304c\u73fe\u5b9f\u7684\u3067\u3059\u3002\u5165\u793e\u6642\u306e\u914d\u5c5e\u5e0c\u671b\u306e\u6bb5\u968e\u3067\u85ac\u4e8b\u5fd7\u671b\u3092\u4f1d\u3048\u3066\u304a\u3051\u3070\u3001\u5c06\u6765\u7684\u306a\u30ad\u30e3\u30ea\u30a2\u306e\u9078\u629e\u80a2\u3068\u3057\u3066\u8003\u616e\u3055\u308c\u3084\u3059\u304f\u306a\u308b\u304b\u3082\u3057\u308c\u307e\u305b\u3093\u3002<\/p>\n<h3><span class=\"ez-toc-section\" id=\"6-2_%E8%BB%A2%E8%81%B7%E3%81%99%E3%82%8B%E5%A0%B4%E5%90%88\"><\/span>6-2. \u8ee2\u8077\u3059\u308b\u5834\u5408<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><span class=\"bold\">\u81e8\u5e8a\u958b\u767a\u30e2\u30cb\u30bf\u30fc(CRA)\u3084\u54c1\u8cea\u4fdd\u8a3c(QA\u30fbQC)\u3001\u30e1\u30c7\u30a3\u30ab\u30eb\u30e9\u30a4\u30c6\u30a3\u30f3\u30b0\u306a\u3069\u306e\u7d4c\u9a13\u304c\u3042\u308b\u4eba\u306f\u3001\u8ee2\u8077\u3067\u85ac\u4e8b\u7533\u8acb\u306e\u696d\u52d9\u306b\u643a\u308f\u308c\u308b\u53ef\u80fd\u6027<\/span>\u304c\u3042\u308a\u307e\u3059\u3002\u3053\u308c\u307e\u3067\u306e\u7d4c\u9a13\u3084\u77e5\u8b58\u304c\u85ac\u4e8b\u696d\u52d9\u3068\u95a2\u9023\u3057\u3066\u3044\u308c\u3070\u3001\u9078\u8003\u3067\u3082\u8a55\u4fa1\u3055\u308c\u3084\u3059\u304f\u306a\u308b\u306f\u305a\u3067\u3059\u3002\u6cbb\u9a13\u3084\u7814\u7a76\u958b\u767a\u306b\u643a\u308f\u3063\u305f\u7d4c\u9a13\u304c\u306a\u3044\u5834\u5408\u306f\u3001\u307e\u305a\u958b\u767a\u696d\u52d9\u53d7\u8a17\u6a5f\u95a2\uff08CRO\uff09\u3084\u88fd\u85ac\u4f01\u696d\u3078\u306e\u5c31\u8077\u3092\u76ee\u6307\u3059\u306e\u304c\u3088\u3044\u3067\u3057\u3087\u3046\u3002<\/p>\n<p>\u30de\u30a4\u30ca\u30d3\u85ac\u5264\u5e2b\u3067\u306f\u3001\u88fd\u85ac\u4f01\u696d\u3084\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u306a\u3069\u4f01\u696d\u85ac\u5264\u5e2b\u5411\u3051\u306e\u6c42\u4eba\u3092\u53d6\u308a\u6271\u3063\u3066\u3044\u307e\u3059\u3002\u5e0c\u671b\u6761\u4ef6\u306b\u5408\u3046\u6c42\u4eba\u304c\u51fa\u305f\u3068\u304d\u306b\u901f\u3084\u304b\u306b\u5bfe\u5fdc\u3067\u304d\u308b\u3088\u3046\u3001\u5b9a\u671f\u7684\u306b\u60c5\u5831\u53ce\u96c6\u3092\u884c\u3044\u307e\u3057\u3087\u3046\u3002<\/p>\n<p>\u53c2\u8003\uff1a<a href=\"https:\/\/pharma.mynavi.jp\/r\/wdb_0702\/\" target=\"_blank\" rel=\"noopener\">\u54c1\u8cea\u7ba1\u7406\u30fb\u54c1\u8cea\u4fdd\u8a3c\u30fbPV\u30fb\u85ac\u4e8b\u306e\u8ee2\u8077\u30fb\u6c42\u4eba\u7279\u96c6<\/a><\/p>\n<h3><span class=\"ez-toc-section\" id=\"6-3_%E9%85%8D%E7%BD%AE%E8%BB%A2%E6%8F%9B%E3%82%92%E5%B8%8C%E6%9C%9B%E3%81%99%E3%82%8B%E5%A0%B4%E5%90%88\"><\/span>6-3. \u914d\u7f6e\u8ee2\u63db\u3092\u5e0c\u671b\u3059\u308b\u5834\u5408<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><span class=\"bold\">\u3059\u3067\u306b\u88fd\u85ac\u4f01\u696d\u306b\u5728\u7c4d\u3057\u3066\u3044\u308b\u5834\u5408\u306f\u3001\u793e\u5185\u516c\u52df\u5236\u5ea6\u306a\u3069\u3092\u901a\u3058\u3066\u85ac\u4e8b\u90e8\u9580\u3078\u306e\u914d\u7f6e\u8ee2\u63db\u3092\u76ee\u6307\u3059\u65b9\u6cd5<\/span>\u304c\u3042\u308a\u307e\u3059\u3002\u5728\u7c4d\u671f\u9593\u4e2d\u306b\u57f9\u3063\u305f\u88fd\u54c1\u77e5\u8b58\u3084\u793e\u5185\u306e\u696d\u52d9\u30d5\u30ed\u30fc\u3078\u306e\u7406\u89e3\u304c\u3042\u308b\u305f\u3081\u696d\u52d9\u306b\u306a\u3058\u307f\u3084\u3059\u304f\u3001\u4f01\u696d\u306b\u3068\u3063\u3066\u3082\u80b2\u6210\u306e\u8ca0\u62c5\u304c\u5c11\u306a\u304f\u6e08\u3080\u30e1\u30ea\u30c3\u30c8\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n<p>\u9762\u63a5\u306b\u81e8\u3080\u969b\u306f\u3001\u52df\u96c6\u3057\u3066\u3044\u308b\u4eba\u6750\u50cf\u3092\u8e0f\u307e\u3048\u305f\u4e0a\u3067\u3001\u81ea\u5206\u306e\u5f37\u307f\u3092\u4f1d\u3048\u308b\u3053\u3068\u304c\u6b20\u304b\u305b\u307e\u305b\u3093\u3002\u307e\u305a\u306f\u52df\u96c6\u8981\u9805\u3092\u8aad\u307f\u8fbc\u307f\u3001\u85ac\u4e8b\u90e8\u9580\u304c\u62c5\u3046\u696d\u52d9\u3084\u4eca\u5f8c\u306e\u65b9\u5411\u6027\u3092\u628a\u63e1\u3057\u3066\u304a\u304d\u307e\u3057\u3087\u3046\u3002\u305d\u306e\u4e0a\u3067\u3001\u3053\u308c\u307e\u3067\u306e\u696d\u52d9\u7d4c\u9a13\u3084\u5f37\u307f\u3092\u68da\u5378\u3057\u3057\u3001\u85ac\u4e8b\u90e8\u9580\u3067\u3069\u3046\u751f\u304b\u305b\u308b\u304b\u3092\u5177\u4f53\u7684\u306b\u8a9e\u308c\u308b\u3088\u3046\u6574\u7406\u3057\u3066\u304a\u304f\u3053\u3068\u304c\u5927\u5207\u3067\u3059\u3002<\/p>\n<div class=\"cv-contents-bottom cvictt\"><a href=\"\/entry2\/index.html\">\n  <div class=\"octagon\">\u7c21\u53581\u5206<\/div>\u7121\u6599\u8ee2\u8077\u30b5\u30dd\u30fc\u30c8\uff01\u3054\u767b\u9332\u306f\u3053\u3061\u3089<i class=\"fas fa-angle-right\"><\/i><\/a><\/div>\n\n<h2><span class=\"ez-toc-section\" id=\"7_%E8%96%AC%E4%BA%8B%E7%94%B3%E8%AB%8B%E6%8B%85%E5%BD%93%E8%80%85%EF%BC%88RA%EF%BC%89%E3%81%AF%E8%96%AC%E5%89%A4%E5%B8%AB%E8%B3%87%E6%A0%BC%E3%82%92%E7%94%9F%E3%81%8B%E3%81%9B%E3%82%8B%E5%B0%82%E9%96%80%E8%81%B7%E3%81%AE%E4%B8%80%E3%81%A4\"><\/span>7. \u85ac\u4e8b\u7533\u8acb\u62c5\u5f53\u8005\uff08RA\uff09\u306f\u85ac\u5264\u5e2b\u8cc7\u683c\u3092\u751f\u304b\u305b\u308b\u5c02\u9580\u8077\u306e\u4e00\u3064<span 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