{"id":1,"date":"2026-07-02T19:35:15","date_gmt":"2026-07-02T11:35:15","guid":{"rendered":"http:\/\/121.199.175.107\/?p=1"},"modified":"2026-07-20T23:25:42","modified_gmt":"2026-07-20T15:25:42","slug":"hello-world","status":"publish","type":"post","link":"https:\/\/www.welltimed.xin\/hello-world\/","title":{"rendered":"Webinar\u9884\u544a:\u805a\u7126\u4e2d\u56fd eCTD v4.0 &amp; \u65b0\u52a0\u5761v1.1"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\">\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\u836f\u54c1\u5ba1\u8bc4\u4e2d\u5fc3(CDE) \u5df2\u4e8e2026\u5e744\u670820\u65e5,\u5728\u5176\u5b98\u65b9\u7f51\u7ad9\u53d1\u5e03\u4e86ICH\u300aM8\uff1a\u7535\u5b50\u901a\u7528\u6280\u672f\u6587\u6863\uff08eCTD\uff09v4.0\u300b\u6307\u5bfc\u539f\u5219\u53ca\u95ee\u7b54\u6587\u4ef6\u4e2d\u6587\u7ffb\u8bd1\u7a3f\uff0c\u5e76\u516c\u5f00\u5f81\u6c42\u610f\u89c1\uff0c<a href=\"https:\/\/www.cde.org.cn\/main\/news\/viewInfoCommon\/87f7cdf8bc0b0dd4f945423d0802eeb6\">\u70b9\u6b64\u67e5\u770b\u539f\u6587\u94fe\u63a5<\/a>\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u5e76\u4e8e2026\u5e745\u670827\u53f7\uff0c\u5728\u5b98\u65b9\u7f51\u7ad9\u53d1\u5e03\u4e86CDE\u8d77\u8349\u7684\u300aeCTD v4.0\u6307\u5bfc\u539f\u5219\u300b\uff0c\u518d\u6b21\u5411\u793e\u4f1a\u516c\u5f00\u5f81\u6c42\u610f\u89c1\uff0c<a href=\"https:\/\/www.cde.org.cn\/main\/news\/viewInfoCommon\/7898f68946d8e8e44d074657c7112002\">\u70b9\u6b64\u539f\u6587\u94fe\u63a5\u3002<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u65b0\u52a0\u5761\u536b\u751f\u79d1\u5b66\u5c40\uff08HSA)\u5df2\u4e8e2026\u5e744\u67081\u65e5\u8d77\u6b63\u5f0f\u63a5\u53d7\u57fa\u4e8eICH eCTD\u89c4\u83033.2.2\u7248\u672cSG-HSA eCTD v1.1\u7684\u7533\u62a5\uff0c\u5f53\u524d\u5e76\u672a\u5f3a\u5236\u8981\u6c42eCTD\u7533\u62a5\uff0c\u4f46\u662f\u5f3a\u70c8\u9f13\u52b1\u8f6c\u6362\u5230eCTD\u7533\u62a5\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u5728\u8fd9\u4e2a\u514d\u8d39\u7f51\u7edc\u7814\u8ba8\u4f1a\u4e2d\uff0c\u6f14\u8bb2\u8005Maren M\u00fcller\u3001Priya Krishnan\u548cMichael Faust\u5c06\u5e26\u60a8\u4e86\u89e3\u4e9a\u6d32eCTD\u683c\u5c40\u7684\u6700\u65b0\u4eae\u70b9\uff0c\u91cd\u70b9\u5173\u6ce8\u4e2d\u56fd\u5411eCTD v4\u7684\u8fc7\u6e21\u3002\u6b64\u5916\uff0c\u6211\u4eec\u7684\u4e13\u5bb6\u5c06\u63a2\u8ba8\u4ece\u533a\u57df\u7248\u672c1.0\u52301.1\u7684\u5173\u952e\u53d8\u5316\uff0c\u4ee5\u53ca\u4e2d\u56fdeCTD v4\u7684\u4e3b\u8981\u7279\u70b9\u3002\u8fd8\u6709\u66f4\u591a\u5185\u5bb9\uff1a\u4e2d\u56fd\u548c\u65b0\u52a0\u5761\u7684\u533a\u57dfeCTD v1.1\u4e5f\u63d0\u4f9b\u4e86\u65b0\u95fb\uff0c\u4f8b\u5982\u8349\u6848\u5b9e\u65bd\u6307\u5357\u3001\u9a8c\u8bc1\u6807\u51c6\u548c\u53d7\u63a7\u8bcd\u6c47\u3002\u5173\u4e8e\u533a\u57dfeCTD\u4e3b\u9898\u7684\u73b0\u573a\u6f14\u793a\u5c06\u63d0\u4f9b\u5bf9\u8fd9\u4e9b\u66f4\u65b0\u53ef\u80fd\u5982\u4f55\u5f71\u54cd\u63d0\u4ea4\u89c4\u5212\u548c\u65e5\u5e38\u76d1\u7ba1\u5de5\u4f5c\u7684\u5b9e\u7528\u89c6\u89d2\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Your Speakers:&nbsp;<\/strong><\/p>\n\n\n\n<figure class=\"wp-block-image size-full\"><img loading=\"lazy\" decoding=\"async\" width=\"340\" height=\"410\" src=\"https:\/\/www.welltimed.xin\/wp-content\/uploads\/2026\/07\/Speaker.png\" alt=\"\" class=\"wp-image-100\" srcset=\"https:\/\/www.welltimed.xin\/wp-content\/uploads\/2026\/07\/Speaker.png 340w, https:\/\/www.welltimed.xin\/wp-content\/uploads\/2026\/07\/Speaker-249x300.png 249w\" sizes=\"auto, (max-width: 340px) 100vw, 340px\" \/><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\">\u8bb2\u5ea7\u65e5\u671f\uff1a2026\u5e747\u670830\u65e5 \u65f6\u95f4\uff1a16:00 CEST(\u6b27\u6d32\u4e2d\u90e8\u590f\u4ee4\u65f6\u95f4\uff09\/ 22:00 CST(\u5317\u4eac\u65f6\u95f4)<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u5982\u60a8\u5bf9\u672c\u6b21\u7814\u8ba8\u4f1a\u611f\u5174\u8da3\uff0c\u8bf7\u5728\u4e0b\u9762\u7559\u8a00\uff0c\u6211\u4eec\u4f1a\u628a\u8bb2\u5ea7\u5f55\u50cf\u53d1\u5230\u60a8\u63d0\u4f9b\u7684\u90ae\u7bb1\u3002<\/p>\n\n\n<p><div class=\"forminator-ui forminator-custom-form forminator-custom-form-33 forminator-design--default forminator-enclosed forminator_ajax\" data-forminator-render=\"0\" data-form=\"forminator-module-33\" data-uid=\"6a5f6d23627f6\"><br\/><\/div><form\n\t\t\t\tid=\"forminator-module-33\"\n\t\t\t\tclass=\"forminator-ui forminator-custom-form forminator-custom-form-33 forminator-design--default forminator-enclosed forminator_ajax\"\n\t\t\t\tmethod=\"post\"\n\t\t\t\tdata-forminator-render=\"0\"\n\t\t\t\tdata-form-id=\"33\"\n\t\t\t\t data-color-option=\"theme\" data-design=\"default\" data-grid=\"enclosed\" style=\"display: none;\"\n\t\t\t\tdata-uid=\"6a5f6d23627f6\"\n\t\t\t><div role=\"alert\" aria-live=\"polite\" class=\"forminator-response-message forminator-error\" aria-hidden=\"true\"><\/div><div class=\"forminator-row\"><div id=\"name-1\" class=\"forminator-field-name forminator-col forminator-col-12 \"><div class=\"forminator-field\"><label for=\"forminator-field-name-1_6a5f6d23627f6\" id=\"forminator-field-name-1_6a5f6d23627f6-label\" class=\"forminator-label\">\u59d3\u540d <span class=\"forminator-required\">*<\/span><\/label><input type=\"text\" name=\"name-1\" value=\"\" placeholder=\"\" id=\"forminator-field-name-1_6a5f6d23627f6\" class=\"forminator-input forminator-name--field\" aria-required=\"true\" autocomplete=\"name\" \/><\/div><\/div><\/div><div class=\"forminator-row\"><div id=\"text-1\" class=\"forminator-field-text forminator-col forminator-col-12 \"><div class=\"forminator-field\"><label for=\"forminator-field-text-1_6a5f6d23627f6\" id=\"forminator-field-text-1_6a5f6d23627f6-label\" class=\"forminator-label\">\u5355\u4f4d\u540d\u79f0 <span class=\"forminator-required\">*<\/span><\/label><input type=\"text\" name=\"text-1\" value=\"\" placeholder=\"\" id=\"forminator-field-text-1_6a5f6d23627f6\" class=\"forminator-input forminator-name--field\" data-required=\"1\" \/><\/div><\/div><\/div><div class=\"forminator-row\"><div id=\"phone-1\" class=\"forminator-field-phone forminator-col forminator-col-12 \"><div class=\"forminator-field\"><label for=\"forminator-field-phone-1_6a5f6d23627f6\" id=\"forminator-field-phone-1_6a5f6d23627f6-label\" class=\"forminator-label\">\u7535\u8bdd\u53f7\u7801 <span class=\"forminator-required\">*<\/span><\/label><input type=\"text\" name=\"phone-1\" value=\"\" placeholder=\"\" id=\"forminator-field-phone-1_6a5f6d23627f6\" class=\"forminator-input forminator-field--phone\" data-required=\"1\" aria-required=\"true\" autocomplete=\"off\" \/><\/div><\/div><\/div><div class=\"forminator-row\"><div id=\"email-1\" class=\"forminator-field-email forminator-col forminator-col-12 \"><div class=\"forminator-field\"><label for=\"forminator-field-email-1_6a5f6d23627f6\" id=\"forminator-field-email-1_6a5f6d23627f6-label\" class=\"forminator-label\">Email\u5730\u5740 <span class=\"forminator-required\">*<\/span><\/label><input type=\"email\" name=\"email-1\" value=\"\" placeholder=\"\" id=\"forminator-field-email-1_6a5f6d23627f6\" class=\"forminator-input forminator-email--field\" data-required=\"true\" aria-required=\"true\" autocomplete=\"email\" \/><\/div><\/div><\/div><div class=\"forminator-row\"><div id=\"textarea-1\" class=\"forminator-field-textarea forminator-col forminator-col-12 \"><div class=\"forminator-field\"><label for=\"forminator-field-textarea-1_6a5f6d23627f6\" id=\"forminator-field-textarea-1_6a5f6d23627f6-label\" class=\"forminator-label\">\u7559\u8a00<\/label><span id=\"forminator-field-textarea-1_6a5f6d23627f6-description\" class=\"forminator-description\"><span data-limit=\"180\" data-type=\"characters\" data-editor=\"\">0 \/ 180<\/span><\/span><textarea name=\"textarea-1\" placeholder=\"\" id=\"forminator-field-textarea-1_6a5f6d23627f6\" class=\"forminator-textarea\" style=\"--forminator-textarea-min-height:140px;\" maxlength=\"180\" ><\/textarea><\/div><\/div><\/div><input type=\"hidden\" name=\"referer_url\" value=\"\" \/><div class=\"forminator-row forminator-row-last\"><div class=\"forminator-col\"><div class=\"forminator-field\"><button class=\"forminator-button forminator-button-submit\">\u63d0\u4ea4<\/button><\/div><\/div><\/div><input type=\"hidden\" id=\"forminator_nonce\" name=\"forminator_nonce\" value=\"a91b8b8f86\" \/><input type=\"hidden\" name=\"_wp_http_referer\" value=\"\/index.php?rest_route=%2Fwp%2Fv2%2Fposts%2F1\" 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\/><\/figure>\n<\/div>\n\n\n<p class=\"wp-block-paragraph\"><\/p>\n","protected":false},"excerpt":{"rendered":"<p>\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\u836f\u54c1\u5ba1\u8bc4\u4e2d\u5fc3(CDE) \u5df2\u4e8e2026\u5e744\u6708&hellip;<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-1","post","type-post","status-publish","format-standard","hentry","category-uncategorized"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.1 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Webinar\u9884\u544a:\u805a\u7126\u4e2d\u56fd eCTD v4.0 &amp; \u65b0\u52a0\u5761v1.1 - \u6cf0\u548c\u9541\u79d1\u6280-\u5fb7\u56fdEXTEDO\u6388\u6743eCTD\u8f6f\u4ef6\u4e13\u4e1a\u670d\u52a1\u5546<\/title>\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.welltimed.xin\/hello-world\/\" \/>\n<meta property=\"og:locale\" content=\"zh_CN\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Webinar\u9884\u544a:\u805a\u7126\u4e2d\u56fd eCTD v4.0 &amp; \u65b0\u52a0\u5761v1.1 - \u6cf0\u548c\u9541\u79d1\u6280-\u5fb7\u56fdEXTEDO\u6388\u6743eCTD\u8f6f\u4ef6\u4e13\u4e1a\u670d\u52a1\u5546\" \/>\n<meta property=\"og:description\" content=\"\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\u836f\u54c1\u5ba1\u8bc4\u4e2d\u5fc3(CDE) \u5df2\u4e8e2026\u5e744\u6708&hellip;\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.welltimed.xin\/hello-world\/\" \/>\n<meta property=\"og:site_name\" content=\"\u6cf0\u548c\u9541\u79d1\u6280-\u5fb7\u56fdEXTEDO\u6388\u6743eCTD\u8f6f\u4ef6\u4e13\u4e1a\u670d\u52a1\u5546\" \/>\n<meta property=\"article:published_time\" content=\"2026-07-02T11:35:15+00:00\" \/>\n<meta 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