{"id":35602,"date":"2018-08-27T01:00:00","date_gmt":"2018-09-17T05:54:46","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/2018\/09\/17\/9%e6%9c%8825-27%e6%97%a5-%e4%b8%8a%e6%b5%b72018%e5%9b%bd%e9%99%85%e5%8c%96%e6%b3%a8%e5%86%8c%e4%b8%93%e5%91%98%e6%8a%80%e8%83%bd%e5%9f%b9%e8%ae%ad%e7%8f%ad-2\/"},"modified":"2018-09-17T13:54:47","modified_gmt":"2018-09-17T05:54:47","slug":"9%e6%9c%8825-27%e6%97%a5-%e4%b8%8a%e6%b5%b72018%e5%9b%bd%e9%99%85%e5%8c%96%e6%b3%a8%e5%86%8c%e4%b8%93%e5%91%98%e6%8a%80%e8%83%bd%e5%9f%b9%e8%ae%ad%e7%8f%ad-2","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/35602\/","title":{"rendered":"9\u670825-27\u65e5 \u4e0a\u6d77\u201c2018\u56fd\u9645\u5316\u6ce8\u518c\u4e13\u5458\u6280\u80fd\u57f9\u8bad\u73ed\u201d"},"content":{"rendered":"
\n

\"9\u670825-27\u65e5<\/p>\n

\u5173\u4e8e\u4e3e\u529e\u201c2018\u56fd\u9645\u5316\u6ce8\u518c\u4e13\u5458\u6280\u80fd\u63d0\u5347\u4e13\u9898\u57f9\u8bad\u73ed\u201d\u7684\u901a\u77e5<\/span><\/p>\n

\u5404\u6709\u5173\u5355\u4f4d\uff1a<\/span><\/p>\n

\u81f3\u4ece2017\u5e74\u4e2d\u56fd\u6b63\u5f0f\u52a0\u5165\u4e86ICH\u4ee5\u6765\uff0c\u836f\u54c1\u6ce8\u518c\u6cd5\u89c4\u90fd\u5728\u671d\u7740ICH\u53ca\u6b27\u7f8e\u6807\u51c6\u6539\u9769\uff0c\u5305\u62ecCTD\uff0c\u5230\u4e34\u5e8a\u5907\u6848\u5236\uff0c\u52a0\u4e0a\u4e4b\u524d\u7684\u4e00\u81f4\u6027\u8bc4\u4ef7\u548c\u5173\u8054\u5ba1\u8bc4\u3002\u4ee5\u4e0a\u8fd9\u4e9b\u53d8\u66f4\uff0c\u4e0d\u4ec5\u5bf9\u5f53\u524d\u6b63\u5904\u4e8e\u53d8\u9769\u671f\u7684\u4e2d\u56fd\u836f\u54c1\u6ce8\u518c\u7533\u62a5\u5177\u6709\u6df1\u8fdc\u7684\u5f71\u54cd\uff0c\u4e5f\u5bf9\u836f\u54c1\u6ce8\u518c\u4e13\u5458\u7684\u5de5\u4f5c\uff0c\u63d0\u51fa\u4e86\u672a\u6765\u7684\u53d1\u5c55\u65b9\u5411\u3002<\/span><\/p>\n

\u4f5c\u4e3a\u836f\u54c1\u6ce8\u518c\u7533\u62a5\u4e2d\u7684\u91cd\u8981\u89d2\u8272\uff0c\u6ce8\u518c\u4e13\u5458\u7684\u6280\u80fd\u6c34\u5e73\u80fd\u5426\u6ee1\u8db3\u5f53\u524d\u56fd\u9645\u5316\u7684\u8d8b\u52bf\uff0c\u80fd\u591f\u76f4\u63a5\u63d0\u5347\u5f71\u54cd\u6ce8\u518c\u4e8b\u52a1\u7684\u8d28\u91cf\u4e0e\u7533\u62a5\u8fdb\u7a0b\uff0c\u662f\u5404\u5927\u836f\u4f01\u5747\u5173\u5fc3\u7684\u5185\u5bb9\u3002\u4e3a\u4e86\u5e2e\u52a9\u5236\u836f\u4f01\u4e1a\u63d0\u9ad8\u836f\u54c1\u7814\u53d1\u6ce8\u518c\u6c34\u5e73\uff0c\u5e2e\u52a9\u6211\u56fd\u836f\u54c1\u6ce8\u518c\u4e13\u5458\u66f4\u597d\u5730\u5b66\u4e60\u836f\u54c1\u6ce8\u518c\u76f8\u5173\u653f\u7b56\u6cd5\u89c4\uff0c\u638c\u63e1\u56fd\u5185\u5916\u836f\u54c1\u6ce8\u518c\u7684\u65b0\u52a8\u5411\uff0c\u5168\u9762\u63d0\u5347\u836f\u54c1\u6ce8\u518c\u4e13\u5458\u7684\u5de5\u4f5c\u80fd\u529b\u548c\u804c\u4e1a\u7d20\u517b\uff0c\u5e2e\u52a9\u5927\u5bb6\u6392\u9664\u836f\u54c1\u6ce8\u518c\u5b9e\u9645\u5de5\u4f5c\u4e2d\u79cd\u79cd\u56f0\u60d1\u4e0e\u96be\u9898\uff0c\u4fc3\u8fdb\u6211\u56fd\u836f\u54c1\u6ce8\u518c\u7533\u62a5\u7684\u8d28\u91cf\u548c\u6548\u7387<\/span>,<\/span>\u672c\u5355\u4f4d\u5b9a\u4e8e<\/span>2018\u5e74<\/span><\/strong>9<\/span><\/strong>\u6708<\/span>2<\/span><\/strong>5<\/span><\/strong>\u65e5\u81f3<\/span>2<\/span><\/strong>7<\/span><\/strong>\u65e5\u5728<\/span><\/strong>\u4e0a\u6d77<\/span><\/strong>\u5e02\u4e3e\u529e<\/span>\u201c2018\u56fd\u9645\u5316\u6ce8\u518c\u4e13\u5458\u6280\u80fd\u63d0\u5347\u4e13\u9898\u57f9\u8bad\u73ed\u201d<\/span><\/strong>\uff0c\u9080\u8bf7\u4e1a\u5185\u6743\u5a01\u4e13\u5bb6\u9488\u5bf9\u76f8\u5173\u95ee\u9898\u8fdb\u884c\u6df1\u5165\u89e3\u6790\uff0c\u8bf7\u4f60\u5355\u4f4d\u79ef\u6781\u9009\u6d3e\u4eba\u5458\u53c2\u52a0\u73b0\u5c06\u6709\u5173\u4e8b\u9879\u901a\u77e5\u5982\u4e0b\uff1a<\/span><\/span><\/p>\n

\u4e00\u3001\u4f1a\u8bae\u5b89\u6392<\/span><\/strong><\/span><\/p>\n

\u4f1a\u8bae\u65e5\u671f\uff1a<\/span>2018\u5e749\u6708<\/span>25-27\u65e5<\/span> (25\u65e5\u5168\u5929\u62a5\u5230<\/span>)<\/span><\/p>\n

\u62a5\u5230\u5730\u70b9\uff1a\u4e0a\u6d77\u5e02<\/span>  (\u5177\u4f53\u5730\u70b9\u76f4\u63a5\u53d1\u7ed9\u62a5\u540d\u4eba\u5458)<\/span><\/p>\n

\u4e8c\u3001\u4f1a\u8bae\u4e3b\u8981\u5185\u5bb9<\/span><\/strong><\/span><\/p>\n

\uff08\u8be6\u89c1\u65e5\u7a0b\u5b89\u6392\uff09<\/span><\/p>\n

\u4e09\u3001\u53c2\u4f1a\u5bf9\u8c61<\/span><\/strong><\/span><\/p>\n

\u4ece\u4e8b\u836f\u54c1\u751f\u4ea7\u3001\u7814\u53d1\u4e0e\u5e94\u7528\u7684\u5236\u836f\u4f01\u4e1a\u3001\u7814\u53d1\u516c\u53f8\u3001\u9ad8\u7b49\u9662\u6821\u3001\u79d1\u7814\u9662\u6240\u3001\u533b\u7597\u673a\u6784\u7b49\u76f8\u5173\u4e13\u4e1a\u4eba\u5458\uff1b\u4ece\u4e8b\u836f\u54c1\u6ce8\u518c\u4eba\u5458\u53ca\u7ba1\u7406\u4eba\u5458\u7b49\uff1b\u4f01\u4e1aQA\u548cQC\u7b49\u76f8\u5173\u4eba\u5458\u3002\u3000<\/span><\/p>\n

\u56db\u3001\u4f1a\u8bae\u8bf4\u660e<\/span><\/strong><\/span><\/p>\n

1\u3001\u7406\u8bba\u8bb2\u89e3,\u5b9e\u4f8b\u5206\u6790,\u4e13\u9898\u8bb2\u6388,\u4e92\u52a8\u7b54\u7591\u3002<\/span><\/span><\/p>\n

2\u3001\u5b8c\u6210\u5168\u90e8\u57f9\u8bad\u8bfe\u7a0b\u8005\u7531\u672c\u534f\u4f1a\u9881\u53d1\u57f9\u8bad\u8bc1\u4e66\u3002<\/span><\/span><\/p>\n

3\u3001\u4f01\u4e1a\u9700\u8981\u5185\u8bad\u548c\u6307\u5bfc\uff0c\u8bf7\u4e0e\u4f1a\u52a1\u7ec4\u8054\u7cfb\u3002<\/span><\/span><\/p>\n

\u4e94\u3001\u4f1a\u8bae\u8d39\u7528<\/span><\/strong><\/span><\/p>\n

\u4f1a\u52a1\u8d39\uff1a<\/span>2500\u5143\/\u4eba\uff08\u8d39\u7528\u542b\u4f1a\u52a1\u8d39\u3001\u8d44\u6599\u8d39\u7b49\uff09\u3002\u98df\u5bbf\u7edf\u4e00\u5b89\u6392\uff0c\u8d39\u7528\u81ea\u7406\u3002<\/span><\/p>\n

\u516d\u3001\u5728\u7ebf\u62a5\u540d\uff08\u626b\u63cf\u4e8c\u7ef4\u7801\uff09<\/span><\/strong><\/span><\/p>\n


<\/span><\/strong><\/span><\/p>\n<\/p>\n

\u7b2c\u4e00\u5929\uff1a<\/span><\/p>\n

\u56fd\u9645<\/span><\/span><\/strong>\u5316\u6ce8\u518c\u4eba\u5458\u7684\u8981\u6c42<\/span><\/span><\/strong><\/p>\n


<\/span><\/span><\/strong><\/p>\n

1.<\/span>\u56fd\u5185\u4f01\u4e1a\u6ce8\u518c\u4eba\u5458\u7684<\/span><\/span>\u7ba1\u7406<\/span><\/span><\/p>\n

\u6ce8\u518c\u5de5\u4f5c\u7684\u5212\u5206<\/span><\/span>  <\/span>\u6ce8\u518c\u4eba\u5458\u5e94\u4e86\u89e3\u7684\u6cd5\u89c4\u53ca\u6280\u80fd<\/span><\/span><\/p>\n

\u6b27\u7f8e\u53cc\u62a5\u7684\u4eba\u5458\u53ca\u5de5\u4f5c\u5b89\u6392<\/span><\/span><\/p>\n

2.<\/span>\u5e38\u89c1\u6ce8\u518c<\/span><\/span>\u76f8\u5173\u7684\u6b27\u7f8e\u5b98\u7f51\u53ca<\/span><\/span>\u5e38\u7528<\/span><\/span>\u5de5<\/span><\/span>\u5177<\/span><\/span><\/p>\n

\u653f\u5e9c\u7f51\u7ad9\u53ca\u65f6\u4fe1\u606f\u67e5\u8be2<\/span><\/span> <\/span>\u836f\u5178\u67e5\u8be2<\/span><\/span> <\/span>\u4e13\u5229\u67e5\u8be2<\/span><\/span> <\/span>\u5176\u4ed6\u6709\u7528\u6570\u636e\u5e93<\/span><\/span><\/p>\n


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

\u4f01\u4e1a<\/span><\/span><\/strong>\u6ce8\u518c\u7533\u62a5<\/span><\/span><\/strong>\u6574\u4f53\u5de5\u4f5c\u7684<\/span><\/span><\/strong>\u7ba1\u7406<\/span><\/span><\/strong>\u548c<\/span><\/span><\/strong>\u5b89<\/span><\/span><\/strong>\u6392<\/span><\/span><\/strong><\/p>\n

1.<\/span>\u7814\u53d1\u7533\u62a5\u5982\u4f55<\/span><\/span>\u89c4\u5212<\/span><\/span>\u53ca<\/span><\/span>\u5206\u5de5<\/span><\/span><\/p>\n

\u5982\u4f55\u6839\u636e\u6700\u65b0\u653f\u7b56\u8c03\u6574\u6ce8\u518c\u5de5\u4f5c<\/span><\/span><\/p>\n

\u6ce8\u518c\u5de5\u4f5c\u5982\u4f55\u53ca\u65f6\u8ddf\u8e2a\u7814\u53d1\u8fdb\u5c55<\/span><\/span><\/p>\n

\u5982\u4f55\u5b9e\u65f6\u8ddf\u8e2a\u8fdb\u5ea6\uff0c\u4ee5\u53ca\u7ea0\u504f\u7ea0\u9519<\/span><\/span><\/p>\n

2.<\/span>\u6ce8\u518c<\/span><\/span>\u73b0\u573a\u68c0\u67e5\u7684\u51c6\u5907<\/span><\/span><\/p>\n

3.<\/span>\u6ce8\u518c\u7533\u62a5\u8fc7\u7a0b\u4e2d\u5b9e\u9645\u5de5\u4f5c\u96be\u9898\u4e0e\u56f0\u60d1\u89e3\u6790<\/span><\/span><\/p>\n


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

\u6ce8\u518c\u8fc7\u7a0b\u4e2d\u7533\u62a5\u8d44\u6599\u7684\u51c6\u5907<\/span><\/span><\/strong><\/p>\n

1.<\/span>CTD<\/span>\u8d44\u6599\u64b0\u5199\u548c\u51c6\u5907<\/span><\/span><\/p>\n

ICH CTD<\/span>\u683c\u5f0f\u7684\u7533\u62a5\u8d44\u6599\u8981\u6c42<\/span><\/span> <\/span>\u76f8\u5173\u90e8\u95e8<\/span><\/span>\u5728<\/span><\/span>CTD\u64b0\u5199<\/span>\u5de5\u4f5c\u4e2d\u5982\u4f55\u914d\u5408<\/span><\/span><\/p>\n

\u5982\u4f55\u51c6\u5907\u836f\u5b66\u53ca\u4e34\u5e8a\u7814\u7a76\u8d44\u6599<\/span><\/span> <\/span>\u5982\u4f55\u628a<\/span><\/span>\u5173\u4e34\u5e8a\u548c\u975e\u4e34\u5e8a\u7533\u62a5\u8d44\u6599<\/span><\/span><\/p>\n

2.<\/span>\u6848\u4f8b\u8bb2\u89e3<\/span><\/span>\uff1a\u67d0\u516c\u53f8\u7684<\/span><\/span>CRO\u5de5\u4f5c<\/span>\u7ba1\u7406\uff0c\u5305\u62ec<\/span><\/span>eCTD\u683c\u5f0f<\/span>\u8f6c\u5316\u7684\u5916\u5305\u7ba1\u7406<\/span><\/span><\/p>\n

3.<\/span>\u6848\u4f8b<\/span><\/span>\u8bb2\u89e3\uff1a<\/span><\/span>\u67d0\u56fd<\/span><\/span>\u9645\u53cc<\/span><\/span>\u62a5<\/span><\/span>\u9879\u76ee\u7684<\/span><\/span>CTD\u64b0\u5199<\/span><\/p>\n


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

\u8bb2\u8bfe\u8001\u5e08\uff1a\u52a1\u8001\u5e08<\/span> \u9ad8\u7ea7\u5de5\u7a0b\u5e08<\/span> \u5927\u578b\u533b\u836f\u96c6\u56e2\u6ce8\u518c\u4e8b\u52a1\u90e8\u90e8\u957f<\/span> \u4ece\u4e8b\u56fd\u5185\u5916\u6ce8\u518c\u5de5\u4f5c\u8fd1\u4e8c\u5341\u5e74<\/span> \u7ecf\u9a8c\u4e30\u5bcc<\/span> \u52a1\u8001\u5e08\u66fe\u4f5c\u4e3a\u534f\u4f1a\u7279\u9080\u5609\u5bbe\u4e3b\u8bb2\u4e86\u56db\u671f\u56fd\u5185\u6ce8\u518c\u4e13\u5458\u8bfe\u7a0b\u548c\u5171\u540c\u5ba1\u8bc4\u7684\u4e94\u671f\u8bfe\u7a0b\uff0c\u6536\u5230\u5b66\u5458\u4e00\u81f4\u597d\u8bc4\u3002<\/span><\/span><\/strong><\/p>\n


<\/p>\n

\u7b2c\u4e8c\u5929<\/span><\/p>\n

2018<\/span><\/strong>\u836f\u54c1\u6ce8\u518c\u7ba1\u7406\u6700\u65b0\u653f\u7b56\u89e3\u8bfb<\/span><\/span><\/strong><\/p>\n


<\/span><\/span><\/strong><\/p>\n

1.<\/span>\u6211\u56fd\u6700\u65b0\u836f\u54c1\u6ce8\u518c\u76f8\u5173\u6cd5\u89c4\u56fd\u9645\u5316\u8d8b\u52bf\u8bb2\u89e3<\/span><\/span><\/p>\n

  a) <\/span>\u4eff\u5236\u836f\u4e00\u81f4\u6027\u8bc4\u4ef7<\/span>\u7cfb\u5217<\/span>\u653f\u7b56<\/span><\/p>\n

  b) <\/span>\u65b0\u836f\u54c1\u6ce8\u518c\u5206\u7c7b\u7b80\u6790<\/span>\u53ca<\/span>\u5f02\u540c\u6bd4\u8f83<\/span><\/p>\n

  c) <\/span>\u4e0a\u5e02\u8bb8\u53ef\u6301\u6709\u4ebaMAH\u7cfb\u5217\u5236\u5ea6\u8ba8\u8bba<\/span><\/p>\n

  d) <\/span>\u539f<\/span>\u8f85<\/span>\u5305\u5171\u540c\u5ba1\u8bc4\u5ba1\u6279<\/span>\u7cfb\u5217<\/span>\u653f\u7b56\u8ba8\u8bba<\/span><\/p>\n

2.<\/span>\u672a\u6765<\/span><\/span>\u6cd5\u89c4<\/span><\/span>\u5411<\/span>ICH<\/span>\u7684\u53d8\u5316\u8d8b\u52bf<\/span><\/span><\/p>\n

FDA<\/span>\u548c\u6b27\u76df\u6ce8\u518c\u6cd5\u89c4\u548c\u6d41\u7a0b\u4ecb\u7ecd<\/span><\/span>\u4ee5<\/span><\/span>\u53ca<\/span><\/span>\u672a\u6765<\/span><\/span>\u6211\u56fd\u7684\u501f\u9274<\/span><\/span><\/p>\n


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

\u6ce8\u518c\u7533\u62a5\u8fc7\u7a0b\u5e38\u89c1\u5173\u952e\u95ee\u9898<\/span><\/span><\/strong><\/p>\n

1.<\/span>\u8d44\u6599\u641c\u96c6\u64b0\u5199\u4e2d\u7684\u5e38\u89c1\u95ee\u9898<\/span><\/span><\/p>\n

\u6570\u636e\u5b8c\u6574\u6027\u786e\u4fdd<\/span><\/span>  <\/span>\u4fdd\u969c\u65f6\u95f4\u8fdb\u5ea6\u53ca\u8d44\u6599\u8d28\u91cf<\/span><\/span><\/p>\n

2.<\/span>\u836f\u54c1\u751f\u4ea7\u73b0\u573a\u68c0\u67e5\u7684\u8981\u70b9\u53ca\u7f3a\u9677\u5206\u6790<\/span><\/span><\/p>\n

\u8fd1\u671f\u56fd\u5185\u5916\u4e0d\u5408\u683c\u9879\u76ee\u6c47\u603b\u5206\u6790<\/span><\/span><\/p>\n

3.<\/span>\u4e00\u81f4\u6027\u8bc4\u4ef7<\/span>\/\u5173\u8054\u5ba1\u8bc4<\/span>\/<\/span>\u518d\u6ce8\u518c\u4e2d\u6613\u5ffd\u7565\u7684\u95ee\u9898<\/span><\/span><\/p>\n


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

\u73b0\u573a\u8ba8\u8bba\u4e92\u52a8<\/span><\/span><\/strong><\/p>\n


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

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