{"id":81636,"date":"2019-03-21T00:00:50","date_gmt":"2019-04-11T06:51:22","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/81636\/"},"modified":"2019-04-11T14:51:23","modified_gmt":"2019-04-11T06:51:23","slug":"2e14c28349","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/81636\/","title":{"rendered":"\u300aeCTD\u6280\u672f\u89c4\u8303\u300b\u548c\u300aeCTD\u9a8c\u8bc1\u6807\u51c6\u300b\u6700\u65b0\u6cd5\u89c4\u8981\u6c42\u89e3\u8bfb"},"content":{"rendered":"
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\u5357\u4eac-\u201c2019 \u300aeCTD\u6280\u672f\u89c4\u8303\u300b\u548c\u300aeCTD\u9a8c\u8bc1\u6807\u51c6\u300b\u6700\u65b0\u6cd5\u89c4\u8981\u6c42\u89e3\u8bfb\u4e13\u9898\u57f9\u8bad\u73ed\u201d\u7684\u901a\u77e5<\/h2>\n
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\u5bfc    \u8bfb
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      <\/span>2017\u5e74<\/span>5\u670830\u65e5C<\/span>FDA\u9996\u6b21\u53d1\u5e03\u300a\u836f\u54c1\u7535\u5b50\u901a\u7528\u6280\u672f\u6587\u6863\u7ed3\u6784\uff08\u5f81\u6c42\u610f\u89c1\u7a3f\uff09\u300b\uff0c\u300a\u5316\u5b66\u4eff\u5236\u836f\u7535\u5b50\u901a\u7528\u6280\u672f\u6587\u6863\u7533\u62a5\u6307\u5bfc\u539f\u5219\uff08\u5f81\u6c42\u610f\u89c1\u7a3f\uff09\u300b\u30022018\u5e747\u67082\u65e5CDE\u59d4\u6258\u4e2d\u56fd\u673a\u68b0\u8fdb\u51fa\u53e3\u6709\u9650\u516c\u53f8\u5b8c\u6210\u7b2c\u4e8c\u6b21\u62db\u6807\uff0c\u4e0a\u6d77\u5b9d\u4fe1\u8f6f\u4ef6\u80a1\u4efd\u6709\u9650\u516c\u53f8\u4ee5609\u4e07\u4e2d\u6807\uff0c\u4e2d\u6807\u6587\u4ef6\u8981\u6c42\u4e2d\u56fd\u7248eCTD\u7cfb\u7edf\u5728<\/span>4\u4e2a\u6708\u5185\u5b8c\u6210\u521d\u6b65\u9a8c\u6536\uff0c7\u4e2a\u6708\u5185\u5b8c\u6210\u6700\u7ec8\u9a8c\u6536\u3002\u4eca\u5e743\u67081\u65e5\uff0cCDE\u53d1\u5e03\u5173\u4e8e\u516c\u5f00\u5f81\u6c42\u300a<\/span>eCTD\u6280\u672f\u89c4\u8303\u300b\u548c\u300aeCTD\u9a8c\u8bc1\u6807\u51c6\u300b\u610f\u89c1\u7684\u901a\u77e5\uff0c\u5f81\u6c42\u65f6\u95f4\u622a\u6b62\u4e8e<\/span>3\u670831\u65e5\u3002\u6839\u636eICH\u7684\u5b9a\u4e49\uff0ceCTD\u662f\u4f01\u4e1a\u4e0e\u836f\u7269\u76d1\u7ba1\u673a\u6784\u8fdb\u884c\u6cd5\u89c4\u4fe1\u606f\u4f20\u8f93\u7684\u63a5\u53e3\uff0c\u540c\u65f6\u517c\u987e\u7535\u5b50\u63d0\u4ea4\u5728\u521b\u5efa\u3001\u5ba1\u67e5\u3001\u751f\u547d\u5468\u671f\u7ba1\u7406\u548c\u5f52\u6863\u65b9\u9762\u7684\u4fbf\u5229\u6027\u3002\u76f8\u8f83\u4e8e\u4f20\u7edf\u7684\u7eb8\u8d28\u6587\u4ef6\u9012\u4ea4\uff0ceCTD\u683c\u5f0f\u7684\u7535\u5b50\u7533\u62a5\u5177\u6709\u9ad8\u6548\u7387\uff0c\u65b9\u4fbf\u67e5\u770b\/\u5bfc\u822a\u3001\u53ef\u5feb\u901f\u6eaf\u6e90\u3001\u5b9e\u73b0\u751f\u547d\u5468\u671f\u7ba1\u7406\u3001\u8282\u7ea6\u7eb8\u5f20\u7b49\u4f18\u52bf\u3002eCTD\u8d44\u6599\u6d89\u53ca\u4e86\u516c\u53f8\u7684\u884c\u653f\uff0c\u7533\u62a5\uff0c\u8d28\u91cf\uff0c\u836f\u5b66\uff0c\u836f\u6bd2\u7406\uff0c\u4e34\u5e8a\uff0c\u7edf\u8ba1\u53ca\u4e34\u5e8a\u836f\u7406\u5b66\u7b49\u5404\u4e13\u4e1a\u90e8\u95e8\u7684\u5de5\u4f5c\uff0ceCTD\u7684\u5b9e\u65bd\u5728\u672c\u8d28\u4e0a\u4e5f\u4fc3\u8fdb\u4e86\u7814\u53d1\u9879\u76ee\u7ba1\u7406\u66f4\u52a0\u7cfb\u7edf\u53ca\u5b8c\u5584\u3002\u9700\u8981\u4f01\u4e1a\u7814\u53d1\u7ba1\u7406\u5c42\u9ad8\u5ea6\u91cd\u89c6\u5e76\u5c3d\u65e9\u5e03\u5c40\u3002\u4e3a\u4e86\u66f4\u597d\u7684\u5e2e\u52a9\u4f01\u4e1a\u6df1\u5165\u7406\u89e3eCTD\uff0c\u6211\u4eec\u9080\u8bf7\u4e86\u56fd\u5185\u5916\u8d44\u6df1\u4e13\u5bb6\u7cfb\u7edf\u4ecb\u7ecdeCTD\u6280\u672f\u89c4\u8303\uff0c\u5236\u5b9a\u601d\u8def\uff0c\u6574\u4f53\u67b6\u6784\uff0c\u7533\u62a5\u8981\u6c42\uff0c\u751f\u547d\u5468\u671f\u4e2d\u7684\u7ec6\u8282\u53ca\u7533\u62a5\u4e2d\u5e38\u89c1\u7684\u9a8c\u8bc1\u95ee\u9898\u548c\u5982\u4f55\u89e3\u51b3\u8fd9\u4e9b\u95ee\u9898\uff1b\u5728\u5efa\u7acb\u5b8c\u5584\u7684\u9879\u76ee\u7ba1\u7406\u53ca\u5b9e\u9a8c\u5ba4\u7ba1\u7406\u7406\u5ff5\u57fa\u7840\u4e0a\u505a\u597d\u5b9e\u65bdeCTD\u524d\u7684\u6218\u7565\u3002<\/span><\/span><\/p>\n

       \u672c\u6b21\u4ea4\u6d41\u4f1a\uff0c \u6743\u5a01\u89e3\u8bfb\u548c\u5b9e\u6218<\/span>\u5206\u4eab\u4e00\u5b9a\u4f1a\u8ba9\u60a8\u4e0d\u865a\u6b64\u884c\uff01<\/span><\/strong>
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\u4e3b\u529e\u5355\u4f4d\uff1a<\/span><\/strong><\/p>\n

\u5317\u4eac\u57f9\u4f18\u521b\u65b0\u533b\u836f\u751f\u7269\u79d1\u6280\u6709\u9650\u516c\u53f8<\/span><\/p>\n

\u4e2d\u56fd\u5316\u5de5\u4f01\u4e1a\u7ba1\u7406\u534f\u4f1a\u533b\u836f\u5316\u5de5\u59d4\u5458\u4f1a<\/span><\/p>\n

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

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

\u5fb7\u5854\u4e91\uff08\u5317\u4eac\uff09\u79d1\u6280\u6709\u9650\u516c\u53f8<\/span><\/p>\n

\u5357\u4eac\u77e5\u548c\u533b\u836f\u79d1\u6280\u6709\u9650\u516c\u53f8<\/span><\/p>\n

\u7231\u601d\u7231\uff08\u5929\u6d25\uff09\u9ad8\u79d1\u6280\u6709\u9650\u516c\u53f8<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n

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\u4f1a\u8bae\u5b89\u6392<\/span><\/strong><\/span><\/section>\n<\/section>\n
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\u4f1a\u8bae\u65f6\u95f4\uff1a<\/span><\/strong>2019\u5e744\u670812<\/span>\u65e5<\/span><\/strong>-14\u65e5<\/span><\/p>\n

\u62a5\u5230\u65f6\u95f4\uff1a12<\/span><\/strong>\u65e5\u5168\u5929\u62a5\u5230<\/span><\/p>\n

\u4f1a\u8bae\u5730\u70b9\uff1a<\/strong><\/span> <\/span>\u5357\u4eac\u5e02<\/span>\uff08\u62a5\u540d\u540e\u5b9a\u5411\u901a\u77e5\uff09<\/span>
<\/p>\n

\u57f9\u8bad\u5bf9\u8c61\uff1a<\/strong><\/span>\u5404\u836f\u54c1\u7814\u7a76\u5355\u4f4d\u53ca\u836f\u54c1\u751f\u4ea7\u4f01\u4e1a\uff0c\u6ce8\u518c\u7533\u62a5\u3001\u5408\u6210\u3001\u8d28\u91cf\u7814\u7a76\u3001\u5236\u5242\u7814\u53d1\u53ca\u9879\u76ee\u7ba1\u7406\uff0c\u4e2d\u9ad8\u5c42\u7ba1\u7406\u4eba\u5458\u53ca\u9879\u76ee\u8d1f\u8d23\u4eba<\/span><\/span><\/p>\n

\u4f1a\u8bae\u8bf4\u660e\uff1a<\/strong><\/span>
<\/p>\n

1. \u7ecf\u9a8c\u5206\u4eab\uff0c\u6388\u4e4b\u4ee5\u6e14       <\/span><\/p>\n

2.\u7406\u667a\u578b\u6559\u5b66\uff0c\u91cd\u5728\u903b\u8f91\u601d\u7ef4\u8bad\u7ec3<\/span><\/p>\n

3.\u6a21\u62df\u5b9e\u9645\u6848\u4f8b\uff0c\u60c5\u666f\u5316\u6f14\u7ec3 <\/span><\/p>\n

4.\u81ea\u7531\u8ba8\u8bba\uff0c\u5404\u6292\u5df1\u89c1<\/span><\/p>\n

5.\u73b0\u573a\u7b54\u7591\uff0c\u652f\u6301\u6311\u6218\u6743\u5a01   <\/span><\/p>\n

6.\u6765\u4e4b\u5fc5\u6709\u6240\u83b7\uff0c\u83b7\u4e4b\u5fc5\u6709\u6240\u7528<\/span><\/p>\n

7.\u5b8c\u6210\u5168\u90e8\u57f9\u8bad\u8bfe\u7a0b\u8005\u7531\u534f\u4f1a\u9881\u53d1\u57f9\u8bad\u8bc1\u4e66<\/span><\/p>\n

8.\u4f01\u4e1a\u9700\u8981GMP\u5185\u8bad\u548c\u6307\u5bfc\uff0c\u8bf7\u4e0e\u4f1a\u52a1\u7ec4\u8054\u7cfb<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

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<\/span><\/strong><\/p>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
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\u65f6\u95f4<\/span><\/strong><\/span><\/p>\n<\/td>\n

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\u4e13\u5bb6<\/span><\/strong><\/span><\/p>\n<\/td>\n

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\u8bfe\u7a0b<\/span><\/strong><\/span><\/p>\n<\/td>\n<\/tr>\n

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4\u6708<\/span>13\u65e5<\/span><\/span><\/p>\n<\/td>\n

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9<\/span>:<\/span>0<\/span>0~<\/span>10:45<\/span><\/span><\/p>\n<\/td>\n

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\u5b59\u7acb\u82f1<\/span><\/strong><\/span><\/p>\n<\/td>\n

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\u4ece\u6839\u672c\u4e0a\u8ba4\u8bc6eCTD<\/span><\/span><\/strong><\/span><\/p>\n

1.\u57fa\u5c42\uff1aeCTD-\u8f6f\u4ef6\u4e0e\u4f7f\u7528\u6280\u672f<\/span><\/p>\n

2.\u4e2d\u5c42\uff1aeCTD-\u6807\u51c6\u4e0e\u8d28\u91cf\u63a7\u5236<\/span><\/p>\n

3.\u9ad8\u5c42\uff1aeCTD-\u836f\u54c1\u751f\u547d\u5468\u671f\u7ba1\u7406\u4e0e\u51b3\u7b56<\/span><\/p>\n

4.\u56fd\u5bb6\uff1aeCTD-\u836f\u54c1\u5b89\u5168\u4e0e\u8d70\u5411\u4e16\u754c\u7684\u57fa\u77f3<\/span><\/p>\n<\/td>\n<\/tr>\n

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1<\/span>0<\/span>:45~<\/span>11<\/span>:00<\/span><\/span><\/p>\n<\/td>\n

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    \u8336\u6b47<\/span><\/p>\n<\/td>\n<\/tr>\n

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11<\/span>:00~<\/span>12:00<\/span><\/span><\/p>\n<\/td>\n

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\u4ed8\u6653\u7ea2<\/span><\/strong><\/span><\/p>\n<\/td>\n

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eCTD\u8f6f\u4ef6\u7b80\u4ecb<\/span><\/strong><\/span><\/p>\n

1.eCTD\u6709\u4ec0\u4e48?\u662f\u4ec0\u4e48\uff1f\u505a\u4ec0\u4e48\uff1f\u600e\u4e48\u505a\uff1f<\/span><\/p>\n

2.<\/span>\u4f01\u4e1a\u4eba\u5de5\u7f16\u5199\u56f0\u96be\u6240\u5728\uff1b<\/span><\/span><\/p>\n

3.<\/span>\u5f00\u59cb\u6ce8\u518c\u7533\u62a5\u524d\u7684\u51c6\u5907\u8d44\u6599\uff1b<\/span><\/span><\/p>\n<\/td>\n<\/tr>\n

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12:00~<\/span>13<\/span>:00<\/span><\/span><\/p>\n<\/td>\n

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\u5348\u9910<\/span><\/p>\n<\/td>\n<\/tr>\n

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13:<\/span>0<\/span>0~<\/span>15<\/span>:<\/span>0<\/span>0<\/span><\/span><\/p>\n<\/td>\n

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\u6768\u6587\u9896<\/span><\/strong><\/span><\/p>\n<\/td>\n

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\u4e00\u3001eCTD\u7684\u524d\u4e16\u4eca\u751f<\/span><\/strong><\/span><\/p>\n

eCTD\u53d1\u5c55\u5386\u53f2\u3001\u5e94\u7528\u8303\u56f4\u3001\u5404\u56fd\u5b9e\u65bd\u73b0\u72b6\u53ca\u672a\u6765\u8d8b\u52bf<\/span><\/p>\n

 <\/span><\/p>\n

\u4e8c\u3001 <\/span>eCTD\u57fa\u7840\u77e5\u8bc6<\/span><\/strong><\/span><\/p>\n

1.<\/span>eCTD\u4e2d\u7684\u4e00\u4e9b\u91cd\u8981\u6982\u5ff5\u89e3\u6790<\/span><\/span><\/span><\/p>\n

2.<\/span>eCTD\u7684\u6700\u4f73\u5236\u4f5c\u6d41\u7a0b<\/span><\/span><\/span><\/p>\n

3.<\/span>eCTD\u7684\u89e3\u51b3\u65b9\u6848\u9009\u62e9\u548c\u6218\u7565\u51c6\u5907<\/span><\/span><\/span><\/p>\n<\/td>\n<\/tr>\n

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15:00~<\/span>15<\/span>:15<\/span><\/span><\/p>\n<\/td>\n

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\u8336\u6b47<\/span><\/p>\n<\/td>\n<\/tr>\n

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15:<\/span>15<\/span>~<\/span>17<\/span>:00<\/span><\/span><\/p>\n<\/td>\n

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\u6768\u6587\u9896<\/span><\/strong><\/span><\/p>\n<\/td>\n

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\u4e09\u3001 <\/span>e<\/span><\/strong>CTD<\/span><\/strong>\u7535\u5b50\u6587\u6863\u7f16\u8f91\u6700\u4f73\u5b9e\u8df5\u6d45\u8c08<\/span><\/strong><\/span><\/p>\n

1. <\/span>\u6587\u6863\u64b0\u5199\u9636\u6bb5<\/span><\/span><\/p>\n

2. <\/span>PDF\u7f16\u8f91\u9636\u6bb5<\/span><\/span><\/span><\/p>\n

3. <\/span>\u6784\u5efaeCTD<\/span>\u9636\u6bb5<\/span><\/span><\/span><\/p>\n

4. <\/span>US\/EU<\/span> eCTD<\/span>\u7533\u62a5\u4e0d\u540c\u70b9\u5bf9\u6bd4<\/span><\/span><\/p>\n

 <\/span><\/p>\n

\u56db\u3001\u4e2d\u56fd\u300aeCTD<\/span>\u6280\u672f\u89c4\u8303\uff08\u5f81\u6c42\u610f\u89c1\u7a3f\uff09\u300b\u53ca\u300a<\/span>eCTD<\/span>\u9a8c\u8bc1\u6807\u51c6\uff08\u5f81\u6c42\u610f\u89c1\u7a3f\uff09\u300b\u89e3\u8bfb<\/span><\/span><\/strong><\/span><\/p>\n<\/td>\n<\/tr>\n

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17:00~18:00<\/span><\/p>\n<\/td>\n

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\u4e92\u52a8\u7b54\u7591<\/span><\/strong><\/span><\/p>\n<\/td>\n<\/tr>\n

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4<\/span>\u6708<\/span>14<\/span>\u65e5<\/span><\/span><\/p>\n<\/td>\n

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8<\/span>:30~1<\/span>0<\/span>:00<\/span><\/span><\/p>\n<\/td>\n

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\u9648\u6d2a<\/span><\/strong><\/span><\/p>\n<\/td>\n

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\u4e00\u3001\u4ece\u7814\u53d1\u89d2\u5ea6\u770be<\/span><\/span>CTD<\/span>\u7684\u7279\u70b9\u53ca\u5bf9\u7814\u53d1\u7684\u5f71\u54cd<\/span><\/span>\u4e8c\u3001 <\/span>\u4f01\u4e1a\u5982\u4f55\u7ec4\u7ec7e<\/span>CTD<\/span>\u5316\u5de5\u4f5c\u7684\u5b9e\u65bd<\/span><\/p>\n

1\uff0e\u56fd\u5185\u4e0d\u540c\u4f01\u4e1a\u7684eCTD\u5b9e\u65bd\u6218\u7565<\/span><\/p>\n

2\uff0eeCTD \u683c\u5f0f\u7533\u62a5\u6d41\u7a0b\u4e0e\u9012\u4ea4\u7ba1\u7406<\/span><\/p>\n

3<\/span>\uff0ee<\/span><\/span>CTD<\/span>\u65f6\u4ee3,<\/span>\u5982\u4f55\u505a\u597d\u9879\u76ee\u7ba1\u7406\u53ca\u4efb\u52a1\u5206\u89e3<\/span><\/span><\/span><\/p>\n

4<\/span>\uff0e<\/span>CTD\u6587\u4ef6\u4e2d\u7684\u6570\u636e\u53ef\u9760\u6027\u95ee\u9898\u5173\u6ce8<\/span><\/span><\/p>\n<\/td>\n<\/tr>\n

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10:00~<\/span>10<\/span>:15<\/span><\/span><\/p>\n<\/td>\n

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\u8336\u6b47<\/span><\/p>\n<\/td>\n<\/tr>\n

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10:15~<\/span>12<\/span>:00<\/span><\/span><\/p>\n<\/td>\n

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\u9648\u6d2a<\/span><\/strong><\/span><\/p>\n<\/td>\n

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\u4e09\u3001eCTD\u5404\u6a21\u5757\u7684\u8981\u6c42\u53ca\u8003\u91cf<\/span><\/p>\n

1\uff0e\u56fd\u5185\u5916\u884c\u653f\u6a21\u677f\u7684\u76f8\u540c\u4e0e\u4e0d\u540c<\/span><\/p>\n

2\uff0e\u6a21\u57572\u548c3\u5bf9\u8d28\u91cf\uff08Q\uff09\u8d44\u6599\u7684\u8981\u6c42<\/span><\/p>\n

3\uff0e\u6a21\u57572\u548c5\u5bf9\u4e34\u5e8a\u8d44\u6599\u7684\u8981\u6c42<\/span><\/p>\n

4\uff0e\u6a21\u57572\u548c4\u5bf9\u975e\u4e34\u5e8a\u8d44\u6599\uff08\u5b89\u5168\u6027\uff09\u7684\u8981\u6c42<\/span><\/p>\n<\/td>\n<\/tr>\n

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12:00~<\/span>13<\/span>:00<\/span><\/span><\/p>\n<\/td>\n

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\u5348\u9910<\/span><\/p>\n<\/td>\n<\/tr>\n

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13:30~<\/span>15<\/span>:00<\/span><\/span><\/p>\n<\/td>\n

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\u9648\u6d2a<\/span><\/strong><\/span><\/p>\n<\/td>\n

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\u56db\u3001 <\/span>\u501f\u9274\u56fd\u5916\uff0ce<\/span>CTD<\/span>\u5982\u4f55\u987a\u5229\u901a\u8fc7\u7533\u62a5<\/span>
<\/p>\n

1.eCTD\u6ce8\u518c\u7533\u62a5\u7acb\u5377\u5ba1\u67e5\u8981\u70b9\u89e3\u6790\uff08FDA\uff09<\/span><\/p>\n

2.\u56fd\u5916eCTD\u683c\u5f0f\u7533\u62a5\u54c1\u79cd\u5ba1\u8bc4\u4e2d\u53d1\u73b0\u7684\u4e3b\u8981\u95ee\u9898<\/span><\/p>\n

3.\u5df2\u7ecf\u5728\u8fdb\u884c\u4e2d\u7684\u7eb8\u8d28\u6587\u6863\u5982\u4f55\u5207\u6362<\/span><\/p>\n<\/td>\n<\/tr>\n

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15:00~15:15<\/span><\/p>\n<\/td>\n

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\u8336\u6b47<\/span><\/p>\n<\/td>\n<\/tr>\n

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15:15~<\/span>16:30<\/span><\/span><\/p>\n<\/td>\n

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\u4ed8\u6653\u7ea2<\/span><\/strong><\/span><\/p>\n<\/td>\n

\n

e<\/span>CTD<\/span>\u8f6f\u4ef6\u5b9e\u64cd\u6f14\u793a<\/span><\/span><\/p>\n<\/td>\n<\/tr>\n

\n

16:00~<\/span>17<\/span>:00<\/span><\/span><\/p>\n<\/td>\n

\n

\u7b54\u7591\u4ea4\u6d41<\/span><\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n


<\/p>\n

<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n

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\u5e08\u8d44\u529b\u91cf<\/span><\/strong><\/span><\/strong><\/span><\/section>\n<\/section>\n


<\/p>\n

\u5b59\u7acb\u82f1\uff08\u6559\u6388\uff0c\u524d<\/span><\/strong>\u7f8e\u56fd<\/span><\/strong>FDA\u8bc4\u5ba1\u7ec4\u957f\uff09<\/span><\/strong><\/span><\/p>\n

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\u4ed8\u6653\u7ea2<\/span><\/strong><\/span><\/p>\n

\u6df1\u5165\u7814\u7a76\u7f8e\u56fd\u3001\u6b27\u76df\u7b49\u591a\u56fd\u6ce8\u518c\u6cd5\u89c4\u53ca<\/span>eCTD\u6587\u6863\u63d0\u4ea4\u8981\u6c42\uff0c\u5e26\u9886\u56e2\u961f\u7814\u53d1\u4e86\u7528\u4e8e\u7f8e\u56fdFDA\u548c\u6b27\u76df\u7684\u4e2d\u6587\u754c\u9762\u4f01\u4e1a\u7aefeCTD\u7cfb\u7edf\uff0c\u5bf9\u5404\u56fd\u7684\u836f\u76d1\u673a\u6784\u7684\u653f\u7b56\u6cd5\u89c4\u3001\u653f\u5e9c\u884c\u653f\u8981\u6c42\uff08M1\uff09\u3001CTD\u6587\u4ef6\u6574\u7406\u3001eCTD\u6587\u4ef6\u7f16\u8f91\u3001\u6821\u9a8c\u89c4\u5219\u548c\u6587\u4ef6\u63d0\u4ea4\u6709\u7cfb\u7edf\u6df1\u523b\u7684\u7406\u89e3\uff0c\u5584\u4e8e\u4eceeCTD\u7cfb\u7edf\u8bbe\u8ba1\u8005\u548c\u5f00\u53d1\u8005\u7684\u89d2\u5ea6\u5206\u6790CTD\u548ceCTD\u6587\u6863\u5e38\u89c1\u6280\u672f\u95ee\u9898\u548c\u51fa\u9519\u7684\u6839\u672c\u539f\u56e0\u3002<\/span><\/span><\/p>\n

\u6768\u6587\u9896<\/span><\/strong><\/span><\/p>\n

DXC Technology \u751f\u547d\u79d1\u5b66\u4e1a\u52a1\u7ebf eCTD\u9ad8\u7ea7\u987e\u95ee<\/span><\/span><\/p>\n

\u7231\u601d\u7231\uff08\u5929\u6d25\uff09\u9ad8\u79d1\u6280\u6709\u9650\u516c\u53f8  \u8d44\u6df1\u9879\u76ee\u7ecf\u7406\/\u54a8\u8be2\u987e\u95ee eCTD\u9ad8\u7ea7\u987e\u95ee \u4ece\u4e8b\u836f\u54c1\u6ce8\u518c\u7535\u5b50\u7533\u62a5\u5de5\u4f5c\u5341\u5e74 \u534f\u52a9\u591a\u5bb6\u4e2d\u56fd\u836f\u4f01\u642d\u5efa\u7535\u5b50\u7533\u62a5\u5e73\u53f0\u3001\u7ec4\u5efa\u548c\u57f9\u8bad\u7f16\u8f91\u56e2\u961f\u3001\u5236\u5b9a\u5de5\u4f5c\u6d41\u7a0b\u89c4\u8303\u53ca\u5b8c\u6210\u5728\u6b27\u7f8e\u7684eCTD\u7533\u62a5\u9879\u76ee\u3002<\/span><\/p>\n

\u9648\u6d2a<\/span><\/strong>\u56fd\u5185\u9f99\u5934\u836f\u4f01\u7814\u7a76\u9662\u526f\u9662\u957f<\/span>,\u9886\u5bfc\u548c\u7ba1\u7406\u836f\u7269\u5408\u6210\uff0c\u5236\u5242\u5f00\u53d1\uff0c\u5206\u6790\u7814\u53d1\u548cANDA\u7533\u62a5\u5168\u8fc7\u7a0b\uff1b\u62e5\u670923\u5e74\u5728\u7f8e\u56fdAdolor\u963f\u9053\u7f57\u5236\u836f\uff0c\u7f8e\u56fdJ&J\u5f3a\u751f\u5236\u836f\uff0c\u7f8e\u56fdTeva\u68af\u74e6\u548cNexgen\u5236\u836f\u516c\u53f8\u7b49\u5de5\u4f5c\u7ecf\u9a8c\u3002\u66fe\u5728\u7f8e\u56fd\u9886\u5bfc\u548c\u7ba1\u7406\u4e00\u4e2a\u670911\u4e2a\u804c\u80fd\u56e2\u961f\u7684GMP\u7814\u53d1\u90e8\u652f\u6301\u516c\u53f8\u7684\u4eff\u5236\u836f\uff08Generic Drug\uff09\u836f\u7269\u7814\u53d1\u3002\u719f\u6089\u4e2d\u56fd\u3001\u6b27\u6d32\u53ca\u7f8e\u56fd\u836f\u54c1\u6ce8\u518c\u6d41\u7a0b\u548c\u6280\u672f\u8981\u6c42\u4ee5\u53caICH\u76f8\u5173\u6307\u5bfc\u539f\u5219\u3002\u7ecf\u9a8c\u975e\u5e38\u4e30\u5bcc\u3002\u534f\u4f1a\u7279\u8058\u4e13\u5bb6\u3002<\/span><\/span><\/p>\n


<\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

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\u62a5\u540d\u8d39\u7528<\/span><\/section>\n<\/section>\n
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1. \u4f1a\u52a1\u8d39\uff1a<\/span><\/strong>2200\/\u4eba\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. \u6c47\u6b3e\u65b9\u5f0f\uff1a<\/strong>
\u6237\u540d\uff1a\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<\/span>\u300aeCTD\u6280\u672f\u89c4\u8303\u300b\u548c\u300aeCTD\u9a8c\u8bc1\u6807\u51c6\u300b\u6700\u65b0\u6cd5\u89c4<\/strong><\/span>\u201c<\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

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\u62a5\u540d\u65b9\u5f0f<\/span><\/strong><\/section>\n<\/section>\n


<\/p>\n

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

\"\u300aeCTD\u6280\u672f\u89c4\u8303\u300b\u548c\u300aeCTD\u9a8c\u8bc1\u6807\u51c6\u300b\u6700\u65b0\u6cd5\u89c4\u8981\u6c42\u89e3\u8bfb\" <\/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>
<\/p>\n

  \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


<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

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\u56de\u6267\u8868<\/span><\/strong><\/span><\/strong><\/span><\/section>\n<\/section>\n

\"\u300aeCTD\u6280\u672f\u89c4\u8303\u300b\u548c\u300aeCTD\u9a8c\u8bc1\u6807\u51c6\u300b\u6700\u65b0\u6cd5\u89c4\u8981\u6c42\u89e3\u8bfb\"<\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

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\u5408\u4f5c\u8d5e\u52a9<\/span><\/strong><\/span><\/strong><\/span><\/section>\n<\/section>\n
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\u62db\u52df\u5408\u4f5c\u8d5e\u52a9\u5355\u4f4d\uff0c\u63d0\u4f9b\u4f01\u4e1a\u5c55\u4f4d\u3001\u5f62\u8c61\u5c55\u793a\u7b49\uff0c\u53ef\u5728\u6587\u7ae0\u4e0b\u65b9\u7559\u8a00\u3002<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n


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

\u5357\u4eac-\u201c2019 \u300aeCTD\u6280\u672f\u89c4\u8303\u300b\u548c\u300aeCTD\u9a8c\u8bc1\u6807\u51c6\u300b\u6700\u65b0\u6cd5\u89c4\u8981\u6c42\u89e3\u8bfb\u4e13\u9898\u57f9\u8bad\u73ed\u201d\u7684\u901a\u77e5 \u5bfc &nbsp […]<\/p>\n","protected":false},"author":1,"featured_media":81637,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[1],"tags":[],"_links":{"self":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/81636"}],"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=81636"}],"version-history":[{"count":1,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/81636\/revisions"}],"predecessor-version":[{"id":81640,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/81636\/revisions\/81640"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media\/81637"}],"wp:attachment":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media?parent=81636"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/categories?post=81636"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/tags?post=81636"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}