{"id":1648,"date":"2021-03-11T18:18:11","date_gmt":"2021-03-11T18:18:11","guid":{"rendered":"http:\/\/www.validant.com\/%e9%81%ba%e4%bc%9d%e5%ad%90%e6%b2%bb%e7%99%82%e3%81%8a%e3%82%88%e3%81%b3%e7%b4%b0%e8%83%9e%e6%b2%bb%e7%99%82\/"},"modified":"2021-04-14T20:47:37","modified_gmt":"2021-04-14T20:47:37","slug":"%e9%81%ba%e4%bc%9d%e5%ad%90%e6%b2%bb%e7%99%82%e3%81%8a%e3%82%88%e3%81%b3%e7%b4%b0%e8%83%9e%e6%b2%bb%e7%99%82","status":"publish","type":"page","link":"https:\/\/www.validant.com\/ja\/%e9%81%ba%e4%bc%9d%e5%ad%90%e6%b2%bb%e7%99%82%e3%81%8a%e3%82%88%e3%81%b3%e7%b4%b0%e8%83%9e%e6%b2%bb%e7%99%82\/","title":{"rendered":"\u907a\u4f1d\u5b50\u6cbb\u7642\u304a\u3088\u3073\u7d30\u80de\u6cbb\u7642"},"content":{"rendered":"\n<section class=\"wp-block-mkl-section-block\"><div class=\"section-bg bg__stretched\" style=\"background-image:url(https:\/\/www.validant.com\/wp-content\/uploads\/2020\/07\/gene-cell-therapy-header-img.jpg);opacity:1\"><\/div>\n<div class=\"wp-block-mkl-section-block container pt-xl\">\n<p><\/p>\n<\/div>\n<\/section>\n\n<section class=\"wp-block-mkl-section-block transparent\">\n<div class=\"wp-block-mkl-section-block has-white-background-color container panel ot-l\">\n<h1 class=\"has-text-align-center pt-xxs wp-block-heading\"><strong><span class=\"has-inline-color has-green-color\">\u907a\u4f1d\u5b50\u6cbb\u7642\u304a\u3088\u3073\u7d30\u80de\u6cbb\u7642<\/span><\/strong>\u3078\u306e\u30a2\u30af\u30bb\u30b9\u3092\u524d\u9032<\/h1>\n\n\n\n<p class=\"has-text-align-center maxc1000 pt-xxs\">\u907a\u4f1d\u5b50\u6cbb\u7642\u304a\u3088\u3073\u7d30\u80de\u6cbb\u7642\u306f\u3001\u5148\u9032\u533b\u7642\u533b\u85ac\u54c1(ATMP)\u3068\u3057\u3066\u3001\u304b\u3064\u3066\u306e\u96e3\u6cbb\u6027\u75be\u75c5\u3092\u3088\u308a\u52b9\u679c\u7684\u306b\u6cbb\u7642\u3059\u308b\u5927\u304d\u306a\u53ef\u80fd\u6027\u3092\u6709\u3057\u3066\u3044\u307e\u3059\u3002\u3053\u306e\u3088\u3046\u306a\u9769\u65b0\u7684\u306a\u6cbb\u7642\u306e\u958b\u767a\u3068\u5546\u54c1\u5316\u3092\u6210\u529f\u3055\u305b\u308b\u306b\u306f\u3001\u3053\u308c\u3089\u306e\u8907\u96d1\u306a\u88fd\u54c1\u306e\u85ac\u4e8b\u898f\u5236\u3001\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u3001\u304a\u3088\u3073\u54c1\u8cea\u306e\u8981\u4ef6\u306b\u3064\u3044\u3066\u3001\u7d30\u304b\u306a\u5dee\u7570\u306b\u6c17\u4ed8\u3051\u308b\u307b\u3069\u306e\u6df1\u3044\u77e5\u8b58\u304c\u5fc5\u8981\u3067\u3059\u3002<strong>Validant\u304c\u9078\u3070\u308c\u308b\u7406\u7531<\/strong><\/p>\n<\/div>\n<\/section>\n\n<section class=\"wp-block-mkl-section-block\">\n<div class=\"wp-block-mkl-section-block container pt-xxs pb-xxs\">\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-9d6595d7 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<figure class=\"wp-block-image size-large\"><img loading=\"lazy\" decoding=\"async\" width=\"500\" height=\"300\" src=\"http:\/\/www.validant.com\/wp-content\/uploads\/2020\/07\/gene-therapy-regulatory-commercialization.jpg\" alt=\"&#x907A;&#x4F1D;&#x5B50;&#x6CBB;&#x7642;&#x304A;&#x3088;&#x3073;&#x7D30;&#x80DE;&#x6CBB;&#x7642;&#x306E;&#x85AC;&#x4E8B;&#x6226;&#x7565;\" class=\"wp-image-1482\" srcset=\"https:\/\/www.validant.com\/wp-content\/uploads\/2020\/07\/gene-therapy-regulatory-commercialization.jpg 500w, https:\/\/www.validant.com\/wp-content\/uploads\/2020\/07\/gene-therapy-regulatory-commercialization-300x180.jpg 300w\" sizes=\"auto, (max-width: 500px) 100vw, 500px\" 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wp-block-heading\"><strong>\u85ac\u4e8b\u6226\u7565\u304b\u3089\u5546\u54c1\u5316\u307e\u3067<\/strong><\/h3>\n\n\n\n<p>Validant\u30c1\u30fc\u30e0\u306e\u4ed6\u306b\u898b\u3089\u308c\u306a\u3044\u307b\u3069\u5145\u5b9f\u3057\u305f\u5c02\u9580\u77e5\u8b58\u306f\u3001\u30e1\u30f3\u30d0\u30fc\u304c\u907a\u4f1d\u5b50\u6cbb\u7642\u304a\u3088\u3073\u7d30\u80de\u6cbb\u7642\u306e\u9769\u65b0\u7684\u4f01\u696d\u3068\u306e\u5354\u696d\u3084\u3001\u305d\u308c\u3089\u306e\u4f01\u696d\u306b\u5728\u7c4d\u3057\u3066\u5f97\u305f\u696d\u754c\u77e5\u8b58\u3068\u3001FDA\u306e\u3088\u3046\u306a\u4fdd\u967a\u5f53\u5c40\u306e\u5728\u7c4d\u671f\u9593\u306b\u5f97\u305f\u85ac\u4e8b\u898f\u5236\u306b\u95a2\u3059\u308b\u6df1\u3044\u5c02\u9580\u77e5\u8b58\u306e\u96c6\u7a4d\u3067\u3059\u3002\u305d\u308c\u3089\u3092\u5408\u308f\u305b\u3066\u3001\u30c1\u30fc\u30e0\u306f\u3053\u308c\u3089\u306e\u6cbb\u7642\u6cd5\u306b\u5fc5\u8981\u306a\u85ac\u4e8b\u6226\u7565\u3001\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u3001\u88fd\u9020\u3001\u304a\u3088\u3073\u54c1\u8cea\u30b7\u30b9\u30c6\u30e0\u3068\u3001\u305d\u308c\u3089\u3092\u6700\u9069\u5316\u3059\u308b\u305f\u3081\u306b\u6700\u826f\u306e\u65b9\u6cd5\u306b\u3064\u3044\u3066\u3001\u5e45\u5e83\u3044\u77e5\u8b58\u3092\u6709\u3057\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u3053\u308c\u306b\u3088\u308a\u3001\u5f53\u793e\u306f\u3001\u907a\u4f1d\u5b50\u6cbb\u7642\u304a\u3088\u3073\u7d30\u80de\u6cbb\u7642\u306e\u6700\u65e9\u671f\u306e\u524d\u81e8\u5e8a\u6bb5\u968e\u304b\u3089\u6d41\u901a\u307e\u3067\u3092\u901a\u3057\u3066\u3001\u304a\u5ba2\u69d8\u3092\u30b5\u30dd\u30fc\u30c8\u3059\u308b\u4e8b\u304c\u53ef\u80fd\u3068\u306a\u308a\u307e\u3059\u3002<\/p>\n<\/div><\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<figure class=\"wp-block-image size-large\"><img loading=\"lazy\" decoding=\"async\" width=\"500\" height=\"300\" src=\"http:\/\/www.validant.com\/wp-content\/uploads\/2020\/07\/gene-cell-therapy-regulations.jpg\" alt=\"&#x907A;&#x4F1D;&#x5B50;&#x6CBB;&#x7642;&#x304A;&#x3088;&#x3073;&#x7D30;&#x80DE;&#x6CBB;&#x7642;&#x306E;&#x30B3;&#x30F3;&#x30D7;&#x30E9;&#x30A4;&#x30A2;&#x30F3;&#x30B9;\" class=\"wp-image-1484\" srcset=\"https:\/\/www.validant.com\/wp-content\/uploads\/2020\/07\/gene-cell-therapy-regulations.jpg 500w, https:\/\/www.validant.com\/wp-content\/uploads\/2020\/07\/gene-cell-therapy-regulations-300x180.jpg 300w\" sizes=\"auto, (max-width: 500px) 100vw, 500px\" \/><\/figure>\n\n\n<div class=\"wp-block-group has-white-background-color has-background pt-xs ot-s z1 mr-m\"><div class=\"wp-block-group__inner-container is-layout-flow wp-block-group-is-layout-flow\">\n<h3 class=\"has-green-color has-text-color icon icon-modalities mb-z wp-block-heading\"><strong>ATMP\u306b\u95a2\u3059\u308b\u4e16\u754c\u7684\u306a\u898f\u683c\u304a\u3088\u3073\u6307\u5c0e\u306e\u30a8\u30ad\u30b9\u30d1\u30fc\u30c8<\/strong><\/h3>\n\n\n\n<p class=\"max500\">\u907a\u4f1d\u5b50\u6cbb\u7642\u304a\u3088\u3073\u7d30\u80de\u6cbb\u7642\u306e\u591a\u304f\u306f\u3001\u30d5\u30a1\u30fc\u30b9\u30c8\u30c8\u30e9\u30c3\u30af\u3001\u753b\u671f\u7684\u6cbb\u7642\u85ac\u3001\u5e0c\u5c11\u75be\u75c5\u7528\u533b\u85ac\u54c1\u6307\u5b9a(ODD)\u306a\u3069\u3001\u8fc5\u901f\u306a\u7d4c\u8def\u3092\u4f7f\u7528\u3057\u3066\u958b\u767a\u3067\u304d\u307e\u3059\u3002Validant\u306e\u30d1\u30fc\u30c8\u30ca\u30fc\u4f01\u696d\u3067\u3042\u308b<a rel=\"noreferrer noopener\" href=\"http:\/\/www.data-revive.com\/\" target=\"_blank\">DataRevive<\/a>\u306f\u5143FDA CBER\u306e\u898f\u5236\u5f53\u5c40\u5c40\u54e1\u3067\u69cb\u6210\u3055\u308c\u3066\u304a\u308a\u3001\u3053\u308c\u3089\u306e\u6cbb\u7642\u6cd5\u306e\u85ac\u4e8b\u7d4c\u8def\u3001\u304a\u3088\u3073\u8fc5\u901f\u306a\u627f\u8a8d\u3092\u53ef\u80fd\u306b\u3059\u308b\u7533\u8acb\u306e\u4f5c\u6210\u65b9\u6cd5\u306b\u7cbe\u901a\u3057\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<p 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wp-container-core-columns-is-layout-9d6595d7 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:33.33%\">\n<h2 class=\"has-white-color has-text-color wp-block-heading\">\u3069\u306e\u3088\u3046\u306a<strong><span class=\"has-inline-color has-lightblue-color\">\u5f53\u793e\u306e\u30b5\u30fc\u30d3\u30b9<br\/><\/span><\/strong>\u304c\u3054\u5e0c\u671b\u3067\u3059\u304b\uff1f<\/h2>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:66.66%\">\n<p class=\"has-text-color has-white-color large\">\u5b9f\u73fe\u3055\u305b\u3088\u3046\u3068\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u304a\u77e5\u3089\u305b\u304f\u3060\u3055\u3044\u3002<br\/><strong>\u5f53\u793e\u306e\u7d4c\u9a13\u3092\u6ce8\u304e\u8fbc\u3093\u3067\u3001\u304a\u5ba2\u69d8\u306e\u5177\u4f53\u7684\u306a\u554f\u984c\u306b\u53d6\u308a\u7d44\u307f\u307e\u3059\u3002<\/strong><\/p>\n\n\n\n<p 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