{"id":128666,"date":"2018-05-22T03:19:52","date_gmt":"2018-05-22T10:19:52","guid":{"rendered":"https:\/\/www.medl10n.com\/?p=128666"},"modified":"2021-04-22T01:40:11","modified_gmt":"2021-04-22T08:40:11","slug":"dia-zhongguoyinglai-10-zhounian-medl10n","status":"publish","type":"post","link":"https:\/\/lifesciences.csoftintl.com\/zh-hans\/blog\/dia-zhongguoyinglai-10-zhounian-medl10n\/","title":{"rendered":"DIA \u4e2d\u56fd\u8fce\u6765 10 \u5468\u5e74\uff0cCSOFT Health Sciences \u5c06\u4e3a\u5927\u4f1a\u63d0\u4f9b\u540c\u4f20\u670d\u52a1"},"content":{"rendered":"

2018 \u5e74\uff0cDIA \u4e2d\u56fd\u5e74\u4f1a<\/a>\u8fce\u6765 10 \u5468\u5c81\uff015 \u6708 23 \u65e5\uff0c\u4e07\u4f17\u77a9\u76ee\u7684 \u201c2018 \u4e2d\u56fd\u56fd\u9645\u836f\u7269\u4fe1\u606f\u5927\u4f1a\u66a8\u7b2c\u5341\u5c4a DIA \u4e2d\u56fd\u5e74\u4f1a\u201d\u5c06\u5728\u5317\u4eac\u56fd\u9645\u4f1a\u8bae\u4e2d\u5fc3\u9686\u91cd\u5f00\u5e55\u3002\u4eca\u5e74\u7684\u5e74\u4f1a\u5c06\u4ee5\u201c\u5341\u5e74\u8015\u8018\u2022\u878d\u5165\u521b\u65b0\u4e16\u754c\uff1b\u5171\u8c31\u534e\u7ae0\u2022\u94f8\u5c31\u5065\u5eb7\u4e2d\u56fd\u201d\u4e3a\u4e3b\u9898\uff0c\u643a\u624b\u836f\u7269\u7814\u53d1\u9886\u57df\u6700\u9876\u7ea7\u7684\u4e13\u5bb6\u3001\u5b66\u8005\u53ca\u836f\u653f\u6cd5\u89c4\u4eba\u5458\uff0c\u89c1\u8bc1\u5e76\u5206\u4eab\u4e2d\u56fd\u533b\u836f\u5065\u5eb7\u4ea7\u4e1a\u84ec\u52c3\u53d1\u5c55\u7684\u7855\u679c\u7d2f\u7d2f\u3002<\/p>\n

\u672c\u6b21\u5e74\u4f1a\u5206\u4e3a ICH<\/a>\uff08International Council for Harmonization\uff09\u4e3b\u9898\u65e5\u4e0e\u4f1a\u8bae\u5c55\u89c8\u65e5\u30025 \u6708 22 \u65e5\uff0c\u5728\u5e74\u4f1a\u6b63\u5f0f\u5f00\u59cb\u524d\uff0cDIA \u4e0e\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08CFDA\uff09\u8054\u5408\u5f00\u5c55\u4e86 ICH \u57f9\u8bad\u65e5\uff0c\u5e2e\u52a9\u53c2\u4f1a\u8005\u4e86\u89e3ICH\u53d1\u5c55\u7684\u6700\u65b0\u56fd\u9645\u8fdb\u5c55\uff0cICH \u65b0\u6307\u5bfc\u539f\u5219\u7684\u9009\u62e9\u548c\u53d1\u5c55\uff0c\u4ee5\u53ca\u5728\u4e2d\u56fd\u5b9e\u65bd\u7684\u6700\u65b0\u8fdb\u5c55\u7b49\u3002<\/p>\n

\u5728 5 \u6708 23-25 \u65e5\u7684\u6b63\u5f0f\u4f1a\u8bae\u4e2d\uff0c\u5c06\u4e3e\u529e\u5f00\u5e55\u5f0f\u4e0e\u5206\u8bba\u575b\uff0c\u5305\u62ec\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\u4e13\u9898\u4f1a\u573a\u3001\u9662\u957f\u5bf9\u8bdd\u3001\u771f\u5b9e\u4e16\u754c\u8bc1\u636e\u7684\u6cd5\u89c4\u8003\u91cf\u3001\u4eba\u5de5\u667a\u80fd\u548c\u60a3\u8005\u53c2\u4e0e\u7b49\u70ed\u95e8\u8bdd\u9898\uff0c\u4ee5\u53ca\u8986\u76d6\u836f\u7269\u7814\u53d1\u6574\u4e2a\u751f\u547d\u5468\u671f\u7684\u5171 14 \u4e2a\u4e13\u9898\u300180 \u591a\u4e2a\u5206\u4f1a\u573a\uff0c\u4e3a\u53c2\u4f1a\u8005\u5e26\u6765\u4e00\u573a\u76f4\u51fb\u6cd5\u89c4\u4e0e\u521b\u65b0\u7684\u9955\u992e\u76db\u5bb4\u3002<\/p>\n

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CSOFT Health Sciences \u4f5c\u4e3a\u00a0CSOFT \u534e\u4e5f\u56fd\u9645\u00a0<\/a>\u65d7\u4e0b\u7684\u751f\u547d\u79d1\u5b66\u90e8\u95e8\uff0c\u4e5f\u53c2\u52a0\u4e86\u672c\u6b21DIA\u4e2d\u56fd\u5e74\u4f1a\u3002CSOFT Health Sciences \u62e5\u6709\u8d85\u8fc713\u5e74\u7684\u4e13\u4e1a\u533b\u5b66\u7ffb\u8bd1\u7ecf\u9a8c\uff0c\u4e0e\u5168\u7403\u591a\u5bb6\u9886\u5148\u7684\u5408\u540c\u7814\u7a76\u7ec4\u7ec7\uff08CRO\uff09\u5408\u4f5c\uff0c\u6709\u5e9e\u5927\u7684\u884c\u4e1a\u4e13\u5bb6\u7f51\u7edc\uff0c\u8303\u56f4\u8986\u76d6\u5404\u79cd\u6cbb\u7597\u9886\u57df\u3002CSOFT Health Sciences \u62e5\u6709\u4e3a\u751f\u547d\u79d1\u5b66\u9886\u57df\u63d0\u4f9b\u9ad8\u54c1\u8d28\u6280\u672f\u7ffb\u8bd1\u7684\u7ecf\u9a8c\u548c\u4e13\u4e1a\u77e5\u8bc6\uff0c\u5e76\u83b7\u5f97 ISO 9001:2015 \u548c ISO 13485:2016 \u8ba4\u8bc1\u7684\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u7684\u652f\u6301\u3002\u6211\u4eec\u7684\u5c55\u4f4d\u53f7\u662fH11\uff0c\u6b22\u8fce\u5404\u4f4d\u670b\u53cb\u524d\u53bb\u4ea4\u6d41\u3002<\/p>\n

\u4f5c\u4e3a\u4eca\u5e74 DIA \u4e2d\u56fd\u7684\u8bed\u8a00\u670d\u52a1\u8d5e\u52a9\u5546\uff0cCSOFT Health Sciences \u8fd8\u5c06\u4e3a\u672c\u6b21\u5e74\u4f1a\u63d0\u4f9b\u9ad8\u8d28\u91cf\u7684\u540c\u4f20\u670d\u52a1\uff0c\u5176\u4e2d\u5305\u62ec\u4eca\u5929\u7684 ICH \u4e3b\u9898\u5927\u4f1a\u3001\u660e\u5929\u7684\u5f00\u5e55\u5f0f\u3001\u4e3b\u65e8\u6f14\u8bb2\uff0c\u4ee5\u53caCFDA\u4e13\u9898\u4f1a\u573a\u7b49 50 \u591a\u573a\u91cd\u8981\u4f1a\u8bae\u3002<\/p>\n

DIA\u4e2d\u56fd\u662fDIA\u4e9a\u6d32\u6700\u5927\u7684\u8de8\u5b66\u79d1\u76db\u4f1a\uff0c\u5c55\u4f1a\u73b0\u573a\u8fd8\u6709\u96c6\u5370\u7ae0\u9001\u793c\u54c1\u6d3b\u52a8\uff0c\u96c6\u6ee150\u4e2a\u5c55\u4f4d\u5370\u7ae0\uff0c\u5c31\u53ef\u9886\u53d6\u5956\u54c1\u4e00\u4efd\u3002 CSOFT Health Sciences \u662f 12 \u4e2a\u5fc5\u76d6\u5370\u7ae0\u4e4b\u4e00\uff0c\u8bb0\u4f4f\u6211\u4eec\u7684\u5c55\u4f4d\u53f7\uff0c\u53c2\u4f1a\u7684\u5c0f\u4f19\u4f34\u4eec\u53ef\u522b\u9519\u8fc7\u54df\uff01<\/p>\n


\n

\u5173\u4e8eDIA<\/strong><\/p>\n

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