{"id":80629,"date":"2019-02-13T00:00:50","date_gmt":"2019-02-26T08:04:59","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/80629\/"},"modified":"2019-02-26T16:04:59","modified_gmt":"2019-02-26T08:04:59","slug":"5f1f3bd492","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/80629\/","title":{"rendered":"\u5173\u4e8e\u4e3e\u529e\u7b2c\u4e8c\u671f\u201c2019 ICH-CTD\u7533\u62a5\u8d44\u6599\u64b0\u5199\u53ca\u51c6\u5907 \u4e13\u9898\u57f9\u8bad\u73ed\u201d\u7684\u901a\u77e5"},"content":{"rendered":"
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\"\u5173\u4e8e\u4e3e\u529e\u7b2c\u4e8c\u671f\u201c2019<\/p>\n

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      CTD\uff08Common Technical Document\uff09\u7533\u62a5\u8d44\u6599\u683c\u5f0f\u662fICH \u5236\u5b9a\u7684\u5173\u4e8e\u836f\u54c1\u7533\u62a5\u6ce8\u518c\u6587\u4ef6\u7684\u7edf\u4e00\u683c\u5f0f\uff0c\u5df2\u5728\u4e16\u754c\u5404\u56fd\u8fbe\u6210\u4e00\u81f4\u6210\u4e3a\u4e86\u5f53\u4eca\u56fd\u9645\u5236\u836f\u5de5\u4e1a\u7684\u4e3b\u6d41\u89c4\u8303\u3002\u8fd1\u5e74\u6765\uff0c\u5168\u7403\u836f\u76d1\u673a\u6784\u5bf9\u4e8e\u836f\u54c1\u6ce8\u518c\u7533\u8bf7\u6587\u4ef6\u7684\u8d28\u91cf\u8981\u6c42\u4e0d\u65ad\u63d0\u9ad8\u3002\u968f\u7740\u4e2d\u56fd\u76d1\u7ba1\u90e8\u95e8\u52a0\u5165ICH\u5e76\u63a5\u53d7\u901a\u7528\u6280\u672f\u6587\u6863(CTD)\u683c\u5f0f\u9012\u4ea4\uff0c\u653f\u7b56\u6cd5\u89c4\u65e5\u8d8b\u56fd\u9645\u5316\uff0c\u8fd9\u7ed9\u836f\u54c1\u7814\u53d1\u4ece\u4e1a\u4eba\u5458\u4e5f\u5e26\u6765\u4e86\u66f4\u591a\u673a\u9047\u548c\u6311\u6218\u3002<\/span><\/p>\n

\u5982\u4f55\u6df1\u5165\u7406\u89e3CTD\u6807\u51c6\u8981\u6c42\uff0c\u901a\u8fc7\u591a\u90e8\u95e8\u7d27\u5bc6\u5408\u4f5c\u9ad8\u6548\u4f18\u8d28\u5730\u5b8c\u6210\u836f\u54c1\u6ce8\u518c\u7533\u62a5\uff0c\u63d0\u9ad8\u6ce8\u518c\u6548\u7387\u4e0e\u6210\u529f\u7387\u3002\u4e3a\u4e86\u5e2e\u52a9\u5236\u836f\u4f01\u4e1a\u63d0\u9ad8\u836f\u54c1\u7814\u53d1\u6ce8\u518c\u6c34\u5e73\uff0c\u5b66\u4e60\u548c\u638c\u63e1 ICH-CTD \u7533\u62a5\u8d44\u6599\u683c\u5f0f\uff0c\u6839\u636eICH-CTD \u7533\u62a5\u8d44\u6599\u683c\u5f0f\u8981\u6c42\u64b0\u5199\u5408\u89c4\u7684\u7533\u62a5\u8d44\u6599\uff0c\u5168\u9762\u63d0\u5347\u836f\u54c1\u7814\u53d1\u4e0e\u6ce8\u518c\u4e13\u5458\u7684\u5de5\u4f5c\u80fd\u529b\u548c\u804c\u4e1a\u7d20\u517b\uff0c\u672c\u5355\u4f4d\u5b9a\u4e8e2019\u5e743\u670815\u65e5\u81f317\u65e5\u5728\u676d\u5dde\u5e02\u4e3e\u529e\u7b2c\u4e8c\u671f\u201c2019 ICH-CTD\u7533\u62a5\u8d44\u6599\u64b0\u5199\u53ca\u51c6\u5907\u4e13\u9898\u57f9\u8bad\u73ed\u201d\uff0c\u9080\u8bf7\u4e1a\u5185\u6743\u5a01\u4e13\u5bb6\u9488\u5bf9\u76f8\u5173\u95ee\u9898\u8fdb\u884c\u6df1\u5165\u89e3\u6790\u3002<\/span><\/p>\n

\u8bda\u9080\u60a8\u53c2\u52a0\u6b64\u6b21\u4ea4\u6d41\u4f1a\uff0c \u6743\u5a01\u89e3\u8bfb\u548c\u5b9e\u6218\u5206\u4eab\u4e00\u5b9a\u4f1a\u8ba9\u60a8\u4e0d\u865a\u6b64\u884c\uff01<\/span><\/strong>
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\u5168\u56fd\u533b\u836f\u6280\u672f\u5e02\u573a\u534f\u4f1a<\/span><\/p>\n

\u5317\u4eac\u534e\u590f\u51ef\u665f\u533b\u836f\u6280\u672f\u4e2d\u5fc3<\/span><\/p>\n

\u652f\u6301\u5355\u4f4d\uff1a<\/strong><\/p>\n

\u9752\u5c9b\u79d1\u521b\u76f8\u5bb9\u6027\u7814\u7a76\u4e2d\u5fc3\uff08\u9ad8\u5206\u5b50\u6750\u6599\u4e13\u5bb6\u5de5\u4f5c\u7ad9\uff09<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n

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\u4f1a\u8bae\u65f6\u95f4\uff1a<\/span><\/strong>2019\u5e743\u670815<\/span>\u65e5<\/span><\/strong>-17\u65e5<\/span><\/p>\n

\u62a5\u5230\u65f6\u95f4\uff1a<\/span><\/strong>1<\/span>5<\/span>\u65e5\u5168\u5929\u62a5\u5230<\/span><\/p>\n

\u4f1a\u8bae\u5730\u70b9\uff1a<\/strong><\/span> <\/span>\u676d\u5dde\u5e02<\/span>\uff08\u62a5\u540d\u540e\u5b9a\u5411\u901a\u77e5\uff09<\/span>
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\u57f9\u8bad\u5bf9\u8c61\uff1a<\/strong><\/span>\u5236\u836f\u4f01\u4e1a\u548c\u7814\u53d1\u673a\u6784\u4ece\u4e8b\u836f\u54c1\u7814\u53d1\u3001\u5236\u5242\u7814\u53d1\u3001\u8d28\u91cf\u7814\u7a76\u3001QA\u3001QC\u3001\u751f\u4ea7\u4eba\u5458\u3001\u5de5\u827a\u4eba\u5458\u548c\u5de5\u7a0b\u4eba\u5458\uff1b\u5927\u4e13\u9662\u6821\u3001\u79d1\u7814\u9662\u6240\u7684\u8001\u5e08\u548c\u540c\u5b66\u7b49\u3002<\/span>
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\u7b2c\u4e00\u5929\uff1a<\/strong><\/span><\/span>09:00-12:00 13:30-17:00<\/strong><\/span><\/span><\/p>\n


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\u8bfe\u98981\uff1aICH-CTD \u6982\u89c8<\/strong><\/span><\/span><\/p>\n

1. CTD\u5728\u56fd\u5185\u5916\u7684\u53d1\u5c55\u5386\u53f2\u53ca\u65b9\u5411<\/span><\/p>\n

a) CTD\u5728\u6b27\u7f8e\u56fd\u5bb6\u7684\u5e94\u7528\u4e0e\u53d1\u5c55<\/span><\/p>\n

b) \u6211\u56fdICH CTD\u5b9e\u65bd\u80cc\u666f\u3001\u8981\u6c42\u548c\u8fdb\u5c55<\/span><\/p>\n

2. CTD \u548ceCTD \u7684\u542b\u4e49\u53ca\u76f8\u4e92\u5173\u7cfb<\/span><\/p>\n

3. CTD\u6982\u8bba<\/span><\/p>\n

c) CTD\u7684\u57fa\u672c\u6784\u67b6<\/span><\/p>\n

d) CTD\u7684\u9002\u7528\u8303\u56f4\u53ca\u57fa\u672c\u539f\u5219<\/span><\/p>\n

e) CTD \u6587\u4ef6\u7cfb\u7edf\u7684\u7279\u70b9<\/span><\/p>\n

4. ICH-CTD \u7684\u6280\u672f\u6307\u5bfc\u539f\u5219\u89e3\u8bfb\uff08M4\uff0cM4Q\uff0cM4S \u548cM4E\uff09<\/span><\/p>\n


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\u8bfe\u98982\uff1aICH-CTD\u5404\u6a21\u5757\u7684\u8981\u6c42\u53ca\u8003\u91cf<\/strong><\/span><\/span><\/p>\n

1. \u6a21\u57571\u533a\u57df\u6027\u6587\u4ef6\u53ca\u6587\u4ef6\u9897\u7c92\u5ea6<\/span><\/p>\n

a) \u5404\u56fd\u6587\u4ef6\u8981\u6c42\u5bf9\u6bd4<\/span><\/p>\n

2. \u6a21\u57572\u548c3\u5bf9\u8d28\u91cf\uff08Q\uff09\u8d44\u6599\u7684\u8981\u6c42<\/span><\/p>\n

a) \u5404\u56fd\u6587\u4ef6\u8981\u6c42\u5bf9\u6bd4\u548c\u6cd5\u89c4\u8003\u91cf<\/span><\/p>\n

b) CTD\u836f\u5b66\u8d44\u6599\u8981\u6c42<\/span><\/p>\n

\u539f\u6599\u836f\u3001\u6742\u8d28\u3001\u65b9\u6cd5\u9a8c\u8bc1\u3001\u914d\u65b9\u751f\u4ea7\u3001\u5305\u6750\u53ca\u7a33\u5b9a\u6027<\/span><\/p>\n

c) \u836f\u54c1\u7814\u53d1\u7b56\u7565<\/span><\/p>\n

3. \u6a21\u57572\u548c5\u5bf9\u4e34\u5e8a\u8d44\u6599\u7684\u8981\u6c42<\/span><\/p>\n

a) \u5404\u56fd\u6587\u4ef6\u8981\u6c42\u5bf9\u6bd4\u548c\u6cd5\u89c4\u8003\u91cf<\/span><\/p>\n

b) \u6a21\u57572.5\uff0c2.7\uff0c5\u7684\u6848\u4f8b\u5206\u4eab<\/span><\/p>\n

4. \u6a21\u57572\u548c4\u5bf9\u975e\u4e34\u5e8a\u8d44\u6599\uff08\u5b89\u5168\u6027\uff09\u7684\u8981\u6c42<\/span><\/p>\n

a) \u5404\u56fd\u6587\u4ef6\u8981\u6c42\u5bf9\u6bd4\u548c\u6cd5\u89c4\u8003\u91cf<\/span><\/p>\n

b) \u6a21\u57572.4\uff0c2.6\u548c4\u7684\u6848\u4f8b\u5206\u4eab<\/span><\/p>\n


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\u7b2c\u4e8c\u5929\uff1a09:00-12:00 13:30-16:30<\/strong><\/span><\/span><\/p>\n


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\u8bfe\u98983\uff1aCTD\u6587\u4ef6\u7684\u64b0\u5199\u683c\u5f0f\u8981\u6c42<\/strong><\/span><\/span><\/p>\n

1. CTD\u683c\u5f0f\u7684\u5173\u952e\u95ee\u9898\u4e0e\u64b0\u5199\u8981\u6c42<\/span><\/p>\n

2. word\u683c\u5f0f\u8bb2\u89e3<\/span><\/p>\n

3. PDF\u683c\u5f0f\u8bb2\u89e3<\/span><\/p>\n

4. \u5982\u4f55\u5bf9\u64b0\u5199\u5de5\u4f5c\u8fdb\u884c\u9879\u76ee\u7ba1\u7406\u4ee5\u63d0\u5347\u6548\u7387<\/span><\/p>\n


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\u8bfe\u98984\uff1aCTD \u5728\u836f\u54c1\u6ce8\u518c\u7533\u62a5\u4e2d\u7684\u5e94\u7528<\/strong><\/span><\/span><\/p>\n

1. \u4e0d\u540c\u7c7b\u522b\u836f\u54c1\u6ce8\u518c\u7533\u62a5\u6587\u4ef6\u7684\u51c6\u5907<\/span><\/p>\n

\u539f\u6599\u836f\/\u53e3\u670d\u56fa\u4f53\u5236\u5242\/\u751f\u7269\u836f<\/span><\/p>\n

2. \u4e0d\u540c\u65f6\u671f\u836f\u54c1\u6ce8\u518c\u7533\u62a5\u6587\u4ef6\u7684\u51c6\u5907<\/span><\/p>\n

\u4e00\u81f4\u6027\/BE<\/span><\/p>\n

3. eCTD \u683c\u5f0f\u7533\u62a5\u6d41\u7a0b\u4e0e\u9012\u4ea4\u7ba1\u7406<\/span><\/p>\n

4. CTD\u6ce8\u518c\u7533\u62a5\u7acb\u5377\u5ba1\u67e5\u8981\u70b9\u89e3\u6790<\/span><\/p>\n

5. \u7533\u62a5\u6587\u4ef6\u751f\u547d\u5468\u671f\u7684\u7ba1\u7406<\/span><\/p>\n

6. CTD\u6587\u4ef6\u4e2d\u7684\u6570\u636e\u53ef\u9760\u6027\u95ee\u9898<\/span><\/p>\n

7. CTD\u683c\u5f0f\u7533\u62a5\u54c1\u79cd\u5ba1\u8bc4\u4e2d\u53d1\u73b0\u7684\u4e3b\u8981\u95ee\u9898<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n

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\u5e08\u8d44\u529b\u91cf\uff1a<\/span><\/strong>\u73b0\u4efb\u5927\u578b\u5916\u8d44\u4f01\u4e1a\u6ce8\u518c\u4e8b\u52a1\u8d1f\u8d23\u4eba\u3002\u62e5\u6709\u8fd1\u4e8c\u5341\u5e74\u7684\u56fd\u5185\u5916\u6cd5\u89c4\u6ce8\u518c\u5de5\u4f5c\u7ecf\u9a8c<\/span> <\/span>\u7b49\u77e5\u540d\u516c\u53f8\u8d1f\u8d23\u6ce8\u518c\u4e8b\u52a1\u5de5\u4f5c\u3002\u719f\u6089\u4e2d\u56fd\u3001\u6b27\u6d32\u53ca\u7f8e\u56fd\u836f\u54c1\u6ce8\u518c\u6d41\u7a0b\u548c\u6280\u672f\u8981\u6c42\u4ee5\u53ca<\/span>ICH<\/span>\u76f8\u5173\u6307\u5bfc\u539f\u5219\u3002\u66fe\u4ee3\u8868\u9ed8\u514b\u4e3a<\/span>CDE<\/span>\u63d0\u4f9b\u76f8\u5173<\/span>ICH<\/span>\u4ecb\u7ecd\u548c\u57f9\u8bad\u3002\u76ee\u524d\u4e3b\u8981\u4ece\u4e8b\u6cd5\u89c4\u6ce8\u518c\u4e8b\u52a1\uff0c\u96c6\u4e2d\u4e8e\u65b0\u4ea7\u54c1\u5168\u7403\u540c\u6b65\u5f00\u53d1\u548c\u6ce8\u518c\u4e0a\u5e02\u7b56\u7565\uff0c\u5df2\u7ecf\u4e2d\u56fd\u548c\u4e9a\u592a\u533a\u5df2\u4e0a\u5e02\u4ea7\u54c1\u7684\u6cd5\u89c4\u6ce8\u518c\u548c\u7ef4\u62a4\u5de5\u4f5c\u3002\u8fd8\u53c2\u4e0e\u8ba8\u8bba\u53ca\u8d77\u8349\u4e86\u4eff\u5236\u836f\u4e00\u81f4\u6027\u8bc4\u4ef7\u76f8\u5173\u6cd5\u89c4\u548c\u6307\u5bfc\u539f\u5219\u4ee5\u53ca\u539f\u8f85\u5305\u5171\u540c\u5ba1\u8bc4\u7ba1\u7406\u529e\u6cd5\u53ca\u5176\u76f8\u5173\u6307\u5bfc\u539f\u5219\u3002\u53e6\u5916\uff0c\u76ee\u524d\u4f5c\u4e3a\u8d44\u6df1\u6cd5\u89c4\u987e\u95ee\uff0c\u7ecf\u9a8c\u975e\u5e38\u4e30\u5bcc\u3002<\/span>\u534f\u4f1a\u7279\u8058\u4e13\u5bb6\u3002<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

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1. \u4f1a\u52a1\u8d39\uff1a<\/span><\/strong>2500\/\u4eba<\/span>\uff08\u4f1a\u52a1\u8d39\u5305\u62ec\uff1a\u57f9\u8bad\u3001\u7814\u8ba8\u3001\u8d44\u6599\u3001\u8336\u6b47\u7b49\uff09\uff1b\u98df\u5bbf\u7edf\u4e00\u5b89\u6392\uff0c\u8d39\u7528\u81ea\u7406\u3002\uff09<\/span><\/p>\n

2. IPPM\u4f1a\u5458\u5355\u4f4d\uff1a<\/strong>\u514d\u8d39
3. \u6c47\u6b3e\u65b9\u5f0f\uff1a<\/strong>
\u6237\u540d\uff1a<\/span>\u5317\u4eac\u90a6\u51ef\u4f01\u4e1a\u7ba1\u7406\u54a8\u8be2\u6709\u9650\u516c\u53f8<\/span><\/p>\n

\u5f00\u6237\u884c\uff1a\u4e2d\u56fd\u5de5\u5546\u94f6\u884c\u5317\u4eac\u7389\u6cc9\u8def\u652f\u884c<\/span><\/span><\/p>\n

\u8d26\u53f7\uff1a020 006 300 920 005 0454<\/span><\/span><\/p>\n

\u5907\u6ce8\uff1a\u4ed8\u6b3e\u8bf7\u6ce8\u660e\u201c\u676d\u5ddeICH-CTD<\/strong>\u201c<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

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1. \u79fb\u52a8\u7aef\u76f4\u63a5\u626b\u63cf\/\u8bc6\u522b\u4e0b\u56fe\u4e8c\u7ef4\u7801\u5373\u53ef\u5728\u7ebf\u62a5\u540d <\/span><\/strong><\/p>\n

\"\u5173\u4e8e\u4e3e\u529e\u7b2c\u4e8c\u671f\u201c2019 <\/span><\/span> <\/span><\/p>\n

2. \u7535\u8111\u7aef\u8bf7\u70b9\u51fb<\/span><\/strong>\u201c\u9605\u8bfb\u539f\u6587\u201d<\/span><\/strong><\/span>\u6216\u590d\u5236\u4e0b\u65b9\u94fe\u63a5\u8fdb\u884c\u62a5\u540d<\/span><\/strong><\/p>\n

  http:\/\/cn.mikecrm.com\/Z40KxrA<\/span><\/p>\n

  3. \u8054\u7cfb\u54a8\u8be2\uff1a<\/span><\/strong>
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  \u8054\u7cfb\u4eba\uff1a<\/span><\/strong>\u5c1a\u8001\u5e08<\/span><\/p>\n

  \u7535\u8bdd\/\u5fae\u4fe1\uff1a<\/span><\/strong>15652565785 <\/span><\/p>\n

  \u90ae\u7bb1\uff1a<\/span><\/strong>2331466365@qq.com<\/span><\/p>\n

  \u4f20\u771f\uff1a <\/span><\/strong>010-63811998<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

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<\/p>\n<\/p><\/div>\n","protected":false},"excerpt":{"rendered":"

\u5bfc    \u8bfb       CTD\uff08Common Techni […]<\/p>\n","protected":false},"author":1,"featured_media":80630,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[2],"tags":[],"_links":{"self":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/80629"}],"collection":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/comments?post=80629"}],"version-history":[{"count":1,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/80629\/revisions"}],"predecessor-version":[{"id":80633,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/80629\/revisions\/80633"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media\/80630"}],"wp:attachment":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media?parent=80629"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/categories?post=80629"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/tags?post=80629"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}