{"id":7506,"date":"2024-08-31T13:09:02","date_gmt":"2024-08-31T05:09:02","guid":{"rendered":"https:\/\/regask.com\/?p=7506"},"modified":"2024-09-25T02:19:23","modified_gmt":"2024-09-24T18:19:23","slug":"fda-2024-%e3%82%b8%e3%82%a7%e3%83%8d%e3%83%aa%e3%83%83%e3%82%af%e5%8c%bb%e8%96%ac%e5%93%81%e3%83%af%e3%83%bc%e3%82%af%e3%82%b7%e3%83%a7%e3%83%83%e3%83%97","status":"publish","type":"post","link":"https:\/\/regask.com\/ja\/fda-2024-generic-drug-workshop\/","title":{"rendered":"\u7c73\u56fd FDA \u306e 2024 \u5e74\u30b8\u30a7\u30cd\u30ea\u30c3\u30af\u533b\u85ac\u54c1\u958b\u767a\u63a8\u9032\u8a08\u753b\u2026"},"content":{"rendered":"<p>FDA \u306e\u533b\u85ac\u54c1\u8a55\u4fa1\u7814\u7a76\u30bb\u30f3\u30bf\u30fc (CDER) \u4e2d\u5c0f\u4f01\u696d\u30fb\u7523\u696d\u652f\u63f4 (SBIA) \u306f\u30012024 \u5e74 9 \u6708 24 \u65e5\u301c 25 \u65e5\u306b\u3001\u5f85\u671b\u306e\u300c2024 \u30b8\u30a7\u30cd\u30ea\u30c3\u30af\u533b\u85ac\u54c1\u958b\u767a\u4fc3\u9032\u30ef\u30fc\u30af\u30b7\u30e7\u30c3\u30d7\u300d\u3092\u4e3b\u50ac\u3059\u308b\u4e88\u5b9a\u3067\u3059\u3002<\/p>\n<p>\u3053\u306e\u30ef\u30fc\u30af\u30b7\u30e7\u30c3\u30d7\u306f\u3001\u30b8\u30a7\u30cd\u30ea\u30c3\u30af\u533b\u85ac\u54c1\u696d\u754c\u306e\u5c02\u9580\u5bb6\u306b\u3068\u3063\u3066\u3001\u6700\u65b0\u306e\u79d1\u5b66\u304a\u3088\u3073\u898f\u5236\u306e\u9032\u6b69\u306b\u95a2\u3059\u308b\u60c5\u5831\u3092\u5165\u624b\u3059\u308b\u305f\u3081\u306e\u91cd\u8981\u306a\u6a5f\u4f1a\u3067\u3059\u3002\u76f4\u63a5\u53c2\u52a0\u3059\u308b\u304b\u3001\u30d0\u30fc\u30c1\u30e3\u30eb\u3067\u53c2\u52a0\u3059\u308b\u304b\u306b\u304b\u304b\u308f\u3089\u305a\u3001\u53c2\u52a0\u8005\u306f\u5b9f\u7528\u7684\u306a\u6d1e\u5bdf\u3068\u3001\u30b8\u30a7\u30cd\u30ea\u30c3\u30af\u533b\u85ac\u54c1\u958b\u767a\u306e\u5c06\u6765\u306e\u5c55\u671b\u306b\u3064\u3044\u3066\u306e\u7406\u89e3\u3092\u6df1\u3081\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002<\/p>\n<p><strong>\u30ef\u30fc\u30af\u30b7\u30e7\u30c3\u30d7\u306e\u91cd\u70b9\u5206\u91ce<\/strong><\/p>\n<p>\u30ef\u30fc\u30af\u30b7\u30e7\u30c3\u30d7\u3067\u306f\u3001\u30b8\u30a7\u30cd\u30ea\u30c3\u30af\u533b\u85ac\u54c1\u696d\u754c\u306e\u767a\u5c55\u306b\u4e0d\u53ef\u6b20\u306a\u4ee5\u4e0b\u306e\u91cd\u8981\u306a\u30c8\u30d4\u30c3\u30af\u306b\u3064\u3044\u3066\u6398\u308a\u4e0b\u3052\u3066\u691c\u8a0e\u3057\u307e\u3059\u3002<\/p>\n<ul>\n<li><strong>\u30a4\u30f3\u30d3\u30c8\u30ed\u7279\u6027\u8a55\u4fa1\u306e\u9032\u6b69<\/strong>\u30b8\u30a7\u30cd\u30ea\u30c3\u30af\u533b\u85ac\u54c1\u306e in vitro \u7279\u6027\u8a55\u4fa1\u3092\u5f37\u5316\u3059\u308b\u6700\u65b0\u306e\u65b9\u6cd5\u8ad6\u3092\u63a2\u308a\u307e\u3059\u3002<\/li>\n<li><strong>\u30ac\u30a4\u30c0\u30f3\u30b9\u958b\u767a\u306e\u305f\u3081\u306e\u7814\u7a76<\/strong>\u8907\u96d1\u306a\u88fd\u54c1\u306b\u95a2\u3059\u308b\u30ac\u30a4\u30c0\u30f3\u30b9\u306e\u958b\u767a\u3092\u76ee\u7684\u3068\u3057\u305f FDA \u306e\u7814\u7a76\u30a4\u30cb\u30b7\u30a2\u30c1\u30d6\u3092\u7406\u89e3\u3057\u307e\u3059\u3002<\/li>\n<li><strong>\u54c1\u8cea\u3068\u52b9\u7387\u306e\u78ba\u4fdd<\/strong>\u30b8\u30a7\u30cd\u30ea\u30c3\u30af\u533b\u85ac\u54c1\u306e\u52b9\u7387\u7684\u306a\u958b\u767a\u3068\u9ad8\u54c1\u8cea\u3092\u78ba\u4fdd\u3059\u308b\u305f\u3081\u306e\u7d99\u7d9a\u7684\u306a\u53d6\u308a\u7d44\u307f\u306b\u3064\u3044\u3066\u5b66\u3073\u307e\u3059\u3002<\/li>\n<\/ul>\n<p>\u53c2\u52a0\u8005\u306f\u3001FDA \u306e\u30b8\u30a7\u30cd\u30ea\u30c3\u30af\u533b\u85ac\u54c1\u30e6\u30fc\u30b6\u30fc\u6599\u91d1\u6539\u6b63 (GDUFA) \u79d1\u5b66\u7814\u7a76\u30d7\u30ed\u30b0\u30e9\u30e0\u304c\u30b8\u30a7\u30cd\u30ea\u30c3\u30af\u533b\u85ac\u54c1\u306e\u958b\u767a\u3001\u898f\u5236\u3001\u627f\u8a8d\u306b\u4e0e\u3048\u308b\u5f71\u97ff\u306b\u3064\u3044\u3066\u3082\u6df1\u304f\u7406\u89e3\u3067\u304d\u308b\u3088\u3046\u306b\u306a\u308a\u307e\u3059\u3002<\/p>\n<p><strong>\u30ef\u30fc\u30af\u30b7\u30e7\u30c3\u30d7\u30b9\u30b1\u30b8\u30e5\u30fc\u30eb<\/strong><\/p>\n<ul>\n<li><strong>1\u65e5\u76ee<\/strong>: 2024 \u5e74 9 \u6708 24 \u65e5\u3001\u5348\u524d 8 \u6642 30 \u5206\uff5e\u5348\u5f8c 4 \u6642 35 \u5206\uff08\u6771\u90e8\u6a19\u6e96\u6642\u9593\uff09<\/li>\n<li><strong>2\u65e5\u76ee<\/strong>: 2024 \u5e74 9 \u6708 25 \u65e5\u3001\u5348\u524d 9 \u6642 \u2013 \u5348\u5f8c 4 \u6642 15 \u5206 (\u6771\u90e8\u6a19\u6e96\u6642)<\/li>\n<\/ul>\n<a href=\"https:\/\/regask.com\/ja\/%e6%8e%a5%e8%a7%a6\/\" target=\"_blank\" class=\"button primary is-link is-medium\" rel=\"noopener\" >\n\t\t<span>\u7d9a\u304d\u3092\u8aad\u3080<\/span>\n\t<\/a>\n\n<p>\u00a9\u3053\u306eRegAlert\u306fRegASK\u306b\u3088\u3063\u3066\u767a\u884c\u3055\u308c\u3066\u3044\u307e\u3059<\/p>","protected":false},"excerpt":{"rendered":"<p>The FDA&#8217;s Center for Drug Evaluation and Research (CDER) Small Business and Industry Assistance (SBIA) is set to host the highly anticipated 2024 Advancing Generic Drug Development Workshop on September 24-25, 2024. This workshop is an essential opportunity for professionals in the generic drug industry to stay informed on the latest scientific and regulatory advancements. Whether attending in person or virtually, participants will leave with actionable insights and a better understanding of the future landscape of generic drug development. Workshop Focus Areas The workshop will delve into critical topics essential for advancing the generic drug industry, including: Advancements in In Vitro Characterization: Explore the latest methodologies enhancing the in vitro&#8230;<\/p>","protected":false},"author":22,"featured_media":7511,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[35],"tags":[177,193,299,481,482,483],"class_list":["post-7506","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-pharma-biotech-latest-insights","tag-labelling","tag-fda","tag-regulatory-intelligence","tag-generic-drugs","tag-webinar","tag-workshop"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.3 (Yoast SEO v27.5) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>FDA&#039;s 2024 Generic Drug Workshop: Key Insights | RegASK<\/title>\n<meta name=\"description\" content=\"The FDA&#039;s 2024 Advancing Generic Drug Development Workshop is essential for industry professionals. 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