{"id":78518,"date":"2019-01-22T00:00:50","date_gmt":"2019-02-01T06:18:19","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/78518\/"},"modified":"2019-02-01T14:18:22","modified_gmt":"2019-02-01T06:18:22","slug":"cd687804d5","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/78518\/","title":{"rendered":"\u3010\u836f\u7814\u30112019\u5206\u6790\u65b9\u6cd5\u8f6c\u79fb\u7684\u56fd\u5185\u5916\u6cd5\u89c4\u4ecb\u7ecd\u4e0e\u6848\u4f8b\u5206\u6790"},"content":{"rendered":"
\n

\"\u3010\u30112019\u5206\u6790\u65b9\u6cd5\u8f6c\u79fb\u7684\u56fd\u5185\u5916\u6cd5\u89c4\u4ecb\u7ecd\u4e0e\u6848\u4f8b\u5206\u6790\"<\/p>\n

\u7814\u7f51\u57f9\u7b2c3\u671f\u66a8\u8bba\u575b\u603b\u7b2c9\u671f<\/span>
<\/p>\n

2019\u5206\u6790\u65b9\u6cd5\u8f6c\u79fb\u6cd5\u89c4\u4ecb\u7ecd\u4e0e\u6848\u4f8b\u5206\u6790<\/span><\/strong><\/strong>
<\/p>\n

\u65f6\u95f4\uff1a2019\u5e7405\u670808–10\u65e5<\/span><\/strong><\/p>\n

\u5f62\u5f0f\uff1a\u7f51\u7edc\u7814\u8ba8\u73ed<\/span><\/strong><\/p>\n


<\/p>\n

\n
\n
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\n
\n
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\n

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


<\/p>\n

\u9080 \u8bf7 \u8f9e<\/span><\/strong><\/span><\/strong><\/strong><\/p>\n

\u5206\u6790\u65b9\u6cd5\u7684\u8f6c\u79fb\u662f\u5206\u6790\u65b9\u6cd5\u5b66\u9a8c\u8bc1\u751f\u547d\u5468\u671f\uff08the Lifecycle f analyticalmethd validatin) \u7684\u6700\u540e\u4e00\u6b65\u3002\u5206\u6790\u65b9\u6cd5\u8f6c\u79fb\u662f\u4fdd\u8bc1\u5df2\u7ecf\u5728R&D\u3001CR\u673a\u6784\u3001API\u751f\u4ea7\u5382\u5bb6\u6240\u5f00\u53d1\u548c\u9a8c\u8bc1\u7684\u5206\u6790\u65b9\u6cd5\uff0c\u5b98\u65b9\u6279\u51c6\uff08\u5728\u7533\u62a5\u8d44\u6599\u4e2d\u63d0\u4ea4\u7684\uff09\u7684\u6807\u51c6\u65b9\u6cd5\uff0c\u4ee5\u53ca\u7ecf\u8fc7\u5168\u9a8c\u8bc1\u7684\u5404\u56fd\u836f\u5178\u65b9\u6cd5\u80fd\u591f\u843d\u5730\u5728\u5236\u5242\u5382QC\u5b9e\u9a8c\u5ba4\u6765\u63a7\u5236\u539f\u8f85\u6599\u7684\u5165\u5382\u68c0\u9a8c\u3001\u836f\u54c1\u653e\u884c\u68c0\u9a8c\u3002\u4ece\u800c\u4fdd\u8bc1\u836f\u54c1\u7684\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\u3002<\/span><\/span><\/p>\n

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<\/p>\n

\u4e3b\u529e\u5355\u4f4d<\/span><\/strong>
<\/span><\/p>\n

\u836f  \u7814<\/span><\/strong><\/p>\n

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

\u5929\u6d25\u5929\u6cb3\u5206\u6790\u4eea\u5668\u6709\u9650\u516c\u53f8<\/span>
<\/p>\n

\u5317\u4eac\u5317\u7814\u79d1\u4eea\u4eea\u5668\u6709\u9650\u8d23\u4efb\u516c\u53f8<\/span>
<\/p>\n

\u676d\u5dde\u79d1\u767e\u7279\u8fc7\u6ee4\u5668\u6750\u6709\u9650\u516c\u53f8<\/span>
<\/p>\n

\u4e0a\u6d77\u535a\u5fd7\u7814\u65b0\u836f\u7269\u6280\u672f\u6709\u9650\u516c\u53f8<\/span><\/p>\n

\u5e7f\u5dde\u4f73\u946b\u533b\u836f\u79d1\u6280\u6709\u9650\u516c\u53f8<\/span>
<\/p>\n

\u91cd\u5e86\u5eb7\u6d32\u5927\u6570\u636e\u6709\u9650\u516c\u53f8<\/span>
<\/p>\n

\u8bfa\u548c\u533b\u836f\u79d1\u6280\u6ca7\u5dde\u6709\u9650\u516c\u53f8<\/span><\/p>\n

\u3010\u6301\u7eed\u62db\u52df\u4e2d\u3011<\/span>
<\/p>\n


<\/p>\n

\n

\u652f\u6301\u5a92\u4f53<\/span><\/strong><\/p>\n

  <\/span><\/p>\n

  \u5dcd\u4fe1<\/span><\/p>\n

\u5c0f\u6728\u866b  \u65b0\u6d6a\u533b\u836f \u65b0\u836f\u6c47<\/span><\/p>\n


<\/p>\n


<\/p>\n

\n
\n
\n
\n
\u4e00<\/strong><\/span><\/section>\n<\/section>\n
\n

\u57f9\u8bad\u5927\u7eb2<\/strong><\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

\n

\u4e0a\u534a\u7a0b\uff1a<\/span>2019\u5e7405\u670808\u65e5\uff08\u5468\u4e09\uff09<\/span><\/strong><\/span>
<\/p>\n

    \n
  1. \n

    \u65b9\u6cd5\u8f6c\u79fb\u5f88\u5bb9\u6613\uff0c\u6211\u4eec\u4e3a\u4ec0\u4e48\u8981\u7ecf\u5386\u6b63\u5f0f\u6d41\u7a0b\uff1f<\/span><\/p>\n<\/li>\n

  2. \n

    \u662f\u5426\u6709\u4efb\u4f55\u7279\u5b9a\u7684ICH\uff0cFDA\uff0cGMP, \u836f\u5178\uff0cWH\u7684\u8981\u6c42\uff1f<\/span><\/p>\n<\/li>\n

  3. \n

    USP1224 \u5bf9\u8f6c\u79fb\u7684\u6307\u5bfc\u548c\u5177\u4f53\u7684\u8981\u6c42<\/span><\/p>\n<\/li>\n

  4. \n

    \u63a5\u6536\u5b9e\u9a8c\u5ba4\u662f\u5426\u5e94\u8fdb\u884c\u5b8c\u5168\u91cd\u65b0\u9a8c\u8bc1\uff1f<\/span><\/p>\n<\/li>\n

  5. \n

    \u63a5\u6536\u5b9e\u9a8c\u5ba4\u5e94\u8be5\u6d4b\u8bd5\u4ec0\u4e48\uff1f<\/span><\/p>\n<\/li>\n

  6. \n

    \u65b9\u6cd5\u8f6c\u79fb\u8fc7\u7a0b\u4e2d\u53ef\u80fd\u51fa\u73b0\u4ec0\u4e48\u95ee\u9898\uff1f<\/span><\/p>\n<\/li>\n

  7. \n

    \u53ea\u505a\u7cfb\u7edf\u9002\u7528\u6027\u6d4b\u8bd5\u662f\u5426\u8db3\u591f\uff1f<\/span><\/p>\n<\/li>\n

  8. \n

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  9. \n

    \u4f55\u65f6\u53ef\u4ee5\u514d\u9664’\u5b98\u65b9’\u65b9\u6cd5\u8f6c\u79fb\uff1f<\/span><\/p>\n<\/li>\n

  10. \n

    \u8f6c\u79fb\u548c\u63a5\u6536\u5b9e\u9a8c\u5ba4\u7684\u804c\u8d23\u662f\u4ec0\u4e48\uff1f<\/span><\/p>\n<\/li>\n

  11. \n

    \u6211\u4eec\u5e94\u8be5\u5982\u4f55\u201c\u6b63\u5f0f\u201d\u8bb0\u5f55\u65b9\u6cd5\u8f6c\u79fb\uff1f<\/span><\/p>\n<\/li>\n

  12. \n

    FDA\u8b66\u544a\u4fe1\u7684\u4f8b\u5b50\u4ee5\u53ca\u5982\u4f55\u907f\u514d\u5b83\u4eec<\/span><\/p>\n<\/li>\n

  13. \n

    \u65b0\u7684FDA\u65b9\u6cd5\u8f6c\u79fb\u6307\u5357\u3002<\/span><\/p>\n<\/li>\n

  14. \n

    \u600e\u4e48\u5236\u5b9a\u5206\u6790\u65b9\u6cd5\u8f6c\u79fb\u6218\u7565<\/span><\/p>\n<\/li>\n

  15. \n

    \u5236\u5b9a\u65b9\u6cd5\u8f6c\u79fb\u7684SP<\/span><\/p>\n<\/li>\n<\/ol>\n


    <\/p>\n

    \u4e0b\u534a\u7a0b\uff1a<\/span>2019\u5e7405\u670810\u65e5\uff08\u5468\u4e94\uff09<\/span><\/strong><\/span><\/p>\n

      \n
    1. \n

      \u8f6c\u79fb\u548c\u63a5\u6536\u5b9e\u9a8c\u5ba4\u7684\u8d23\u4efb<\/span><\/p>\n<\/li>\n

    2. \n

      \u5236\u5b9a\u8f6c\u79fb\u8ba1\u5212\uff1a\u5185\u5bb9\u548c\u6279\u51c6<\/span><\/p>\n<\/li>\n

    3. \n

      \u65b9\u6cd5\u8f6c\u79fb\u9009\u9879<\/span><\/p>\n<\/li>\n

    4. \n

      \u9a8c\u6536\u6807\u51c6\u7684\u91cd\u8981\u6027<\/span><\/p>\n<\/li>\n

    5. \n

      \u6bd4\u8f83\u7814\u7a76<\/span><\/p>\n<\/li>\n

    6. \n

      \u65b9\u6cd5\u8f6c\u79fb\u671f\u95f4\u5f88\u53ef\u80fd\u53d1\u751f\u7684\u95ee\u9898<\/span><\/p>\n<\/li>\n

    7. \n

      \u65b9\u6cd5\u8f6c\u79fb\u8c41\u514d\u6807\u51c6<\/span><\/p>\n<\/li>\n

    8. \n

      \u65b9\u6cd5\u8f6c\u79fb\u65b9\u6848\u548c\u6458\u8981\u62a5\u544a\u4e3e\u4f8b<\/span><\/p>\n<\/li>\n

    9. \n

      \u8f6c\u79fb\u5931\u8d25\u5b9e\u4f8b\u8bf4\u660e<\/span><\/p>\n<\/li>\n

    10. \n

      \u8f6c\u79fb\u6837\u54c1\u7684\u9009\u62e9<\/span><\/p>\n<\/li>\n

    11. \n

      \u51fa\u73b0\u504f\u5dee\u6216\u6ca1\u6709\u8fbe\u5230\u9884\u671f\u8bbe\u5b9a\u7684\u63a5\u53d7\u6807\u51c6\u600e\u4e48\u529e<\/span><\/p>\n<\/li>\n

    12. \n

      \u65f6\u95f4\u7d27\u8feb\u7684\u6761\u4ef6\u4e0b\u65b9\u6cd5\u8f6c\u79fb\u5b9e\u4f8b<\/span><\/p>\n<\/li>\n

    13. \n

      \u5176\u4ed6<\/span><\/p>\n<\/li>\n<\/ol>\n

      \n


      <\/p>\n

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      \u4e8c<\/strong><\/span><\/section>\n<\/section>\n
      \n

      \u8bb2\u5e08\u4ecb\u7ecd<\/strong><\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

       <\/p>\n

      \n
      \n
      \"\u3010\u30112019\u5206\u6790\u65b9\u6cd5\u8f6c\u79fb\u7684\u56fd\u5185\u5916\u6cd5\u89c4\u4ecb\u7ecd\u4e0e\u6848\u4f8b\u5206\u6790\"<\/section>\n
      \n

       <\/span>\u9648\u6d2a <\/span><\/strong><\/span>\u535a\u58eb<\/span><\/strong><\/span>
      <\/p>\n

      \u4ee5\u5cad\u836f\u4e1a\u5316\u7a76\u9662\u9662\u957f\u3001\u539fTeva\u5206\u6790\u603b\u76d1<\/span><\/strong><\/span><\/p>\n

      1991 \u5e74\u8d74\u7f8e\u56fd\u7559\u5b66\uff0c\u540e\u83b7\u5f97\u4e86\u7f8e\u56fd\u514b\u5229\u592b\u5170\u5dde\u7acb\u5927\u5b66\u5206\u6790\u5316\u5b66\u4e13\u4e1a\u535a\u58eb\u5b66\u4f4d\uff0c\u88ab\u7f8e\u56fd\u514b\u5229\u592b\u5170\u533b\u5b66\u4e2d\u5fc3\u8058\u4e3a\u751f\u7269\u533b\u836f\u4e13\u4e1a\u535a\u58eb\u540e\u7814\u7a76\u5458\u3002\u81ea 1998 \u5e74\u5f00\u59cb\u5230 2015\u5e743 \u6708\u4e00\u76f4\u5728\u7f8e\u56fd\u4ece\u4e8b\u836f\u7269\u7814\u53d1\u5de5\u4f5c\u3002\u4ed6\u5148\u540e\u5728\u65b0\u4e00\u4ee3\u5236\u836f\u516c\u53f8\u3001\u5f3a\u751f\u5236\u836f\u548cTeva\u5236\u836f\u516c\u53f8\u7b49\u56fd\u9645\u77e5\u540d\u5236\u836f\u4f01\u4e1a\u7684\u7814\u53d1\u90e8\u95e8\u62c5\u4efb\u5206\u6790\u7814\u53d1\u603b\u76d1\u7b49\u804c\u52a1\uff0c\u4ed6\u9886\u5bfc\u548c\u4e3b\u6301\u5f00\u53d1\u7684\u836f\u7269\u6709 \u5341\u4f59\u4e2a\u901a\u8fc7 FDA \u6279\u51c6\u4e0a\u5e02\uff0c\u8fd8\u6709\u5341\u51e0\u4e2a\u54c1\u79cd\u5728 FDA \u7684\u5ba1\u8bc4\u8fc7\u7a0b\u4e2d\u3002\u5728\u5316\u53d1\u65b9\u9762\uff0c\u4ed6\u5177\u6709\u6df1\u539a\u7684\u7406\u8bba\u77e5\u8bc6\u53ca\u5b9e\u8df5\u3001\u4e30\u5bcc\u7684\u56fd\u9645\u5316\u53d1\u548c\u79d1\u7814\u7ba1\u7406\u7ecf\u9a8c\u3002<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n


      <\/p>\n

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      \u4e09<\/strong><\/span><\/section>\n<\/section>\n
      \n

      \u57f9\u8bad\u4f18\u52bf <\/strong><\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

      \n

      \u603b\u4f53\u6765\u8bb2\uff0c\u5728\u7ebf\u57f9\u8bad\u66f4\u52a0\u6ce8\u91cd\u4e8e\u57f9\u8bad\u5185\u5bb9\u7684\u201c\u4e13\u201d\u548c\u201c\u7cbe\u201d\uff0c\u6bcf\u6b21\u57f9\u8bad\u9009\u62e9\u4e00\u4e2a\u5927\u5bb6\u9700\u6c42\u5ea6\u8f83\u5927\u7684\u4e3b\u9898\u8fdb\u884c\u4e00\u6b21\u6df1\u5165\u57f9\u8bad\uff0c\u65f6\u5e38\u4e0d\u5c11\u4e8e7\u5c0f\u65f6\uff0c\u628a\u4e3b\u9898\u8bb2\u6df1\u3001\u8bb2\u900f\uff01\u6b64\u5916\uff0c\u9664\u9ad8\u6548\u3001\u4fbf\u6377\u3001\u7ecf\u6d4e\u7b49\u4f18\u52bf\u5916\uff0c\u8fd8\u6709\u5176\u4ed6\u4f17\u591a\u4f18\u52bf\uff0c\u8be6\u89c1\u4e0b\u6587\u622a\u56fe\uff1a<\/span>
      <\/p>\n

      \u5907\u6ce8\uff1a\u5bf9\u57f9\u8bad\u65b9\u5f0f\u4e0d\u4e86\u89e3\u7684\u8001\u5e08\uff0c\u4e5f\u53ef\u5148\u884c\u4f53\u9a8c\u540e\u518d\u62a5<\/span><\/strong>\u540d\u3002<\/span><\/strong><\/span><\/p>\n

      \"\u3010\u30112019\u5206\u6790\u65b9\u6cd5\u8f6c\u79fb\u7684\u56fd\u5185\u5916\u6cd5\u89c4\u4ecb\u7ecd\u4e0e\u6848\u4f8b\u5206\u6790\"<\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

      \n
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      \u56db<\/strong><\/span><\/section>\n<\/section>\n
      \n

      \u57f9\u8bad\u65f6\u95f4 <\/strong><\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

      \n

      \u4e0a\u534a\u7a0b\uff1a<\/span><\/strong><\/p>\n

      2019\u5e7405\u670808\u65e5\uff08\u5468\u4e09\uff09\uff0c\u4e0a\u53488:30–12:00\uff08\u542b\u7b54\u7591\uff09<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

      \u4e0b\u534a\u7a0b\uff1a<\/span><\/strong><\/p>\n

      2019\u5e7405\u670810\u65e5\uff08\u5468\u4e94\uff09\uff0c\u4e0a\u53488:30–12:00\uff08\u542b\u7b54\u7591\uff09<\/span><\/p>\n

      \n
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      \n
      \u4e94<\/strong><\/section>\n<\/section>\n
      \n

      \u4f1a\u8bae\u62a5\u540d<\/strong><\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

      \n

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      <\/p>\n

      1<\/strong>.\u62a5\u540d\uff1a\u5201\u8001\u5e08\uff0c15911172616\uff0c\u4e5f\u53ef\u957f\u5b89\u4e0b\u65b9\u4e8c\u7ef4\u7801\u767b\u8bb0\uff0c\u7531\u4f1a\u52a1\u7ec4\u8054\u7cfb\u60a8\u53d1\u9001\u62a5\u540d\u8868\u3002<\/span><\/strong><\/span><\/strong><\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

      \"\u3010\u30112019\u5206\u6790\u65b9\u6cd5\u8f6c\u79fb\u7684\u56fd\u5185\u5916\u6cd5\u89c4\u4ecb\u7ecd\u4e0e\u6848\u4f8b\u5206\u6790\"<\/p>\n

      \u957f\u6309\u4e8c\u7ef4\u7801\u767b\u8bb0<\/span>
      <\/p>\n


      <\/p>\n

      \n

      2<\/span>.\u62a5\u540d\u8d39\u53ca\u4f18\u60e0<\/span><\/strong>
      <\/p>\n<\/section>\n

      \n
      \n
      \n
      \n
      \n

      \u539f\u4ef7\uff1a5500\u5143\/\u8d26\u53f7\u3002\u65e9\u9e1f\u4f18\u60e0<\/span>\u4ef7<\/span>\uff1a<\/span><\/p>\n

      3\u67081\u65e5\u524d\u7f34\u8d39\uff1a48<\/span>00\u5143\/\u8d26\u53f7\uff1b<\/span><\/strong><\/p>\n

      4\u67081\u65e5\u524d\u7f34\u8d39\uff1a5100\u5143\/\u8d26\u53f7\uff1b<\/span><\/strong><\/p>\n

      4\u67082\u65e5\u8d77\u7f34\u8d39\uff1a5500\u5143\/\u8d26\u53f7<\/strong><\/span><\/strong><\/p>\n

      \u5907\u6ce8\uff1a<\/span><\/strong>1.\u540c\u96c6\u56e2\u591a\u4e2a\u5206\u516c\u53f8\u53c2\u52a0\u7684\u5206\u522b\u7ed9\u4e88\u51cf\u514d500\u5143\u4f18\u60e0\u30022.\u7f34\u7eb3\u62a5\u540d\u8d39\u540e\u53d6\u6d88\u53c2\u4f1a\u7684\uff0c4\u670830\u65e5\u524d\u53d6\u6d88\u9000\u8fd8\u5168\u90e8\u8d39\u7528\uff0c5\u67087\u65e5\u524d\u9000\u8fd880%\u3002\u4f1a\u8bae\u5f00\u59cb\u540e\u6055\u4e0d\u518d\u9000\u6b3e\u3002<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

      3.\u7f34\u8d39<\/span><\/strong><\/strong>\u65b9\u5f0f<\/span><\/strong>
      <\/p>\n

      \u6237\u540d\uff1a\u8bfa\u548c\u533b\u836f\u79d1\u6280\u6ca7\u5dde\u6709\u9650\u516c\u53f8<\/span><\/span><\/p>\n

      \u8d26\u53f7\uff1a<\/span>0408<\/span>01080930<\/span>0138975<\/span><\/span><\/strong><\/span><\/p>\n

      \u5f00\u6237\u884c\uff1a\u4e2d\u56fd\u5de5\u5546\u94f6\u884c\u6ca7\u5dde\u798f\u5bbe\u652f\u884c<\/span><\/p>\n

      \u5982\u4e3a\u4e2a\u4eba\u94f6\u884c\u7f51\u94f6\u8f6c\u8d26\uff0c\u8bf7\u5907\u6ce8\u201c\u4ee3XX\u516c\u53f8\u7f34\u7eb3\u62a5\u540d\u8d39\u201d<\/span><\/p>\n

      \u5176\u4ed6\u652f\u4ed8\u65b9\u5f0f\uff1a\u652f\u4ed8\u5b9d\uff0c15911172616<\/span><\/p>\n

      4.\u62a5\u540d\u54a8\u8be2<\/span><\/strong>
      <\/span><\/p>\n

      \u5201\u8001\u5e08\uff1a\u624b\u673a<\/span>15911172616
      <\/span><\/p>\n

      \u90ae\u7bb1\uff1a<\/span>15911172616@qq.com<\/span>
      <\/p>\n

      \u5fae\u4fe1\uff1a<\/span>diaodiao666666<\/span><\/span><\/p>\n


      <\/p>\n

      \"\u3010\u30112019\u5206\u6790\u65b9\u6cd5\u8f6c\u79fb\u7684\u56fd\u5185\u5916\u6cd5\u89c4\u4ecb\u7ecd\u4e0e\u6848\u4f8b\u5206\u6790\"<\/span><\/p>\n

      \n
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      \n
      \u516d<\/strong><\/section>\n<\/section>\n
      \n

      \u96c6\u8d5e\u6d3b\u52a8<\/strong><\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

      \n

      \u51e1\u53c2\u52a0\u672c\u6b21\u57f9\u8bad\u4eba\u5458\uff0c\u5c06\u672c\u57f9\u8bad\u4fe1\u606f\u4e8e<\/span>05\u65e501\u65e5\u524d\u5206\u4eab\u81f3\u670b\u53cb\u5708<\/span>\u96c6\u6ee1<\/span>36\u4e2a\u8d5e\u5e76\u4e0a\u4f20\u81f3\u4e0b\u65b9\u4e8c\u7ef4\u7801<\/span><\/span><\/strong>\uff0c\u53ef\u5728\u4f1a\u540e7\u4e2a\u5de5\u4f5c\u65e5\u5185\u83b7\u8d60\u4e0b\u5217\u7eb8\u8d28\u8d44\u6599\u548c\u5956\u54c1\uff089\u90091\uff09\uff1a<\/span><\/span><\/p>\n

      1.2019\u6700\u65b0\u7248ICHQ1-Q12\u4e2d\u82f1\u6587\u8d44\u6599\u4e00\u5957\uff082\u672c\u7ea6800\u9875\uff09
      <\/span><\/section>\n
      2.2019\u6700\u65b0\u7248ICHM4CTD\u901a\u7528\u6280\u672f\u6587\u6863\u4e2d\u82f1\u6587\u8d44\u6599\u4e00\u5957\uff081\u672c\u7ea6300\u9875\uff09
      <\/span><\/section>\n
      3.2019ICHM7\u57fa\u56e0\u6bd2\u6027\u6742\u8d28\u4e2d\u82f1\u6587\u8d44\u6599\u4e00\u5957\uff081\u672c\u7ea6150\u9875\uff09
      <\/span><\/section>\n
      \n
      4.2019\u8ba1\u7b97\u673a\u5316\u7cfb\u7edf\u9a8c\u8bc1\u548c\u6570\u636e\u5b8c\u6574\u6027\u6307\u5357\u4e2d\u82f1\u6587\u5bf9\u7167\u88c5\u8ba2\u7248\u672c\u5408\u96c6\u4e00\u5957\uff082\u672c\u7ea6500\u9875\uff09<\/span><\/section>\n<\/section>\n<\/section>\n

      \n
      \n
      5.ICH\u672f\u8bed\u53e3\u888b\u4e66-ICH\u7cfb\u5217\u4e2d\u82f1\u6587\u5bf9\u7167\uff08\u5305\u62ecQ,S,E,M\u5404\u90e8\u5206\uff09-A5\u7248\u9762\uff081\u672c260\u591a\u9875\uff09<\/span><\/section>\n<\/section>\n<\/h3>\n
      6.<\/span><\/section>\n
      \n
      2019\u6700\u65b0CEP\/COS\u6b27\u6d32\u836f\u5178\u9002\u7528\u6027\u8ba4\u8bc1\u6307\u5357\u4e2d\u82f1\u5bf9\u7167\u5408\u96c6\u4e00\u5957\uff082\u672c400<\/span>\u591a\u9875<\/span>\uff09
      <\/span><\/section>\n<\/section>\n
      \n
      7.2019\u6700\u65b0OMCL\u5b98\u65b9\u836f\u54c1\u63a7\u5236\u5b9e\u9a8c\u5ba4-\u8d28\u91cf\u7ba1\u7406\u6587\u4ef6\u4e2d\u82f1\u5bf9\u7167\u4e00\u5957\uff082\u672c500<\/span>\u591a\u9875<\/span>\uff09
      <\/span><\/section>\n<\/section>\n
      \n
      8.2018FDA\u836f\u7269CGMP\u73b0\u573a\u68c0\u67e5\u8b66\u544a\u4fe1\u4e2d\u82f1\u5bf9\u7167\u4e00\u5957\uff081\u672c\u7ea6<\/span>400<\/span>\u9875<\/span>\uff09<\/span><\/section>\n<\/section>\n
      \n
      \n
      9.\u8ba2\u5236\u724832G\u4f18\u76d82\u4e2a<\/span><\/section>\n<\/section>\n


      <\/section>\n


      <\/p>\n

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      <\/p>\n

      \"\u3010\u30112019\u5206\u6790\u65b9\u6cd5\u8f6c\u79fb\u7684\u56fd\u5185\u5916\u6cd5\u89c4\u4ecb\u7ecd\u4e0e\u6848\u4f8b\u5206\u6790\"<\/p>\n

      \n
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      \n
      \u4e03<\/strong><\/span><\/section>\n<\/section>\n
      \n

      \u62db\u52df\u5408\u4f5c\u5355\u4f4d<\/strong><\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

      \n

      \u62db\u52df\u5408\u4f5c\u8d5e\u52a9\u5355\u4f4d\/\u57f9\u8bad\u8bb2\u5e08\/\u5ba3\u4f20\u5a92\u4f53\uff0c\u6d3d\u8c08\u7535\u8bdd\uff1a15911172616<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

      \n
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      \n
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      \u516b<\/strong><\/section>\n<\/section>\n
      \n

      \u7b80\u4ecb<\/span><\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

      \n

      <\/span><\/strong>\u662f\u4e00\u4e2a\u836f\u7269\u7814\u53d1\u9886\u57df\u4e13\u4e1a\u7684\u516c\u5171\u54a8\u8be2\u670d\u52a1\u5e73\u53f0\u30022016\u5e74\u6210\u7acb\u4e4b\u521d\u5373\u4e3a\u5e7f\u5927\u5236\u836f\u9886\u57df\u540c\u4ec1\u79ef\u6781\u63d0\u4f9b\u56fd\u5185\u5916\u4e13\u4e1a\u7684\u836f\u7269\u7814\u7a76\u3001\u6ce8\u518c\u4ee5\u53ca\u4eff\u5236\u836f\u4e00\u81f4\u6027\u8bc4\u4ef7\u76f8\u5173\u8d44\u8baf\uff0c\u77ed\u65f6\u95f4\u5185\u83b7\u5f97\u5927\u91cf\u540c\u4ec1\u7684\u9752\u7750\u548c\u5173\u6ce8\u3002\u76ee\u524d\u5236\u836f\u9886\u57df\u5173\u6ce8\u7528\u6237\u7ea63\u4e07\u4eba\uff0c\u56e2\u961f\u7ea620\u4eba\u30022017\u5e74\u5e94\u5e7f\u5927\u5236\u836f\u540c\u4ec1\u63d0\u8bae\u5f00\u59cb\u6d89\u53ca\u7814\u53d1\u9886\u57df\u57f9\u8bad\u4e1a\u52a1\uff0c\u76ee\u524d\u5df2\u7b79\u529e\u591a\u671f\u57f9\u8bad\uff0c\u53e6\u6709\u591a\u573a\u57f9\u8bad\u5c06\u4e8e\u540e\u671f\u53d1\u5e03\u3002\u622a\u81f32018\u5e7412\u6708\u5df2\u4e3a\u5305\u62ec\u626c\u5b50\u6c5f\u836f\u4e1a\u96c6\u56e2\u3001\u77f3\u836f\u96c6\u56e2\u3001\u534e\u6d77\u836f\u4e1a\u3001\u4e3d\u73e0\u96c6\u56e2\u3001\u9999\u6e2f\u6fb3\u7f8e\u3001\u5b9c\u660c\u4e1c\u9633\u5149\u3001\u4e2d\u56fd\u533b\u5b66\u79d1\u5b66\u9662\u3001\u4e2d\u56fd\u79d1\u5b66\u9662\u3001\u4e0a\u6d77\u5f3a\u751f\u3001\u8fdc\u5927\u96c6\u56e2\u3001\u6b63\u5927\u5929\u6674\u3001\u8c6a\u68ee\u836f\u4e1a\u3001\u6d77\u6b63\u836f\u4e1a\u3001\u5929\u58eb\u529b\u96c6\u56e2\u3001\u4ee5\u5cad\u836f\u4e1a\u3001\u534e\u6da6\u7d2b\u7af9\u3001\u534e\u6da6\u53cc\u9e64\u3001\u5317\u4eac\u6cf0\u5fb7\u5236\u836f\u3001\u6c5f\u82cf\u5148\u58f0\u836f\u4e1a\u3001\u5317\u4eac\u97e9\u7f8e\u7b49\u77e5\u540d\u4f01\u4e1a\u5728\u5185\u7684\u8fd1600\u4f01\u4e1a\u548cCRO\u63d0\u4f9b\u4e86\u9ad8\u8d28\u91cf\u7684\u4e13\u4e1a\u5316\u57f9\u8bad\uff0c\u5747\u6536\u5230\u826f\u597d\u6548\u679c\uff0c\u4f1a\u540e\u83b7\u5f97\u53c2\u4f1a\u4f01\u4e1a\u4e00\u81f4\u597d\u8bc4\u3002<\/span><\/p>\n


      <\/p>\n

      \u96441\uff1a\u5f80\u671f\u57f9\u8bad\u76db\u51b5\uff08\u7ebf\u4e0b\u57f9\u8bad\uff09<\/span><\/strong><\/section>\n


      <\/p>\n


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

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      <\/p>\n

      \u7b2c3\u671f\uff1a<\/span>\u3010\u7ec8\u8f6e\u901a\u77e5\u3011\u5236\u5242\u5904\u65b9\u5de5\u827a\u548c\u751f\u7269\u7b49\u6548\u6027\uff08BE\uff09\u8bd5\u9a8c\u7ba1\u7406\u53ca \u4e00\u81f4\u6027\u8bc4\u4ef7\u6ce8\u518c\u7533\u62a5\u53ca\u8fce\u68c0<\/a><\/p>\n

      \u7b2c4\u671f\uff1a<\/span>\u30106\u670823\u65e5\u3011\u738b\u5efa\u82f1\u535a\u58eb\u8385\u4e342018\u6b27\u7f8e\u4eff\u5236\u836f\u548c\u539f\u6599\u836f\u56fd\u9645\u6ce8\u518c\u4f1a\u8bae\u5e76\u4f5c\u4e3b\u65e8\u62a5\u544a<\/a><\/p>\n

      \u7b2c5\u671f\uff1a<\/span>\u70ed\u70c8\u795d\u8d3a\u3010\u8bba\u575b\u7b2c5\u671f \u6ce8\u5c04\u5242\u4e00\u81f4\u6027\u8bc4\u4ef7\u5173\u952e\u6280\u672f\u4e0e\u6848\u4f8b\u5206\u6790\u3011\u53d6\u5f97\u5706\u6ee1\u6210\u529f\uff01\uff01<\/a><\/p>\n

      \u7b2c6\u671f\uff1a<\/span>\u3010\u5706\u6ee1\u843d\u5e55\u30112018\u6ce8\u5c04\u5242\u4e00\u81f4\u6027\u8bc4\u4ef7\u5173\u952e\u6280\u672f\u4e0e\u6848\u4f8b\u5206\u6790<\/a><\/p>\n


      <\/p>\n

      \u5173\u6ce8\uff0c\u968f\u65f6\u4e86\u89e3\u4f1a\u8bae\u6700\u65b0\u5185\u5bb9\uff01<\/span><\/strong>
      <\/p>\n


      <\/p>\n

      \u53ef\u70b9\u51fb\u5de6\u4e0b\u89d2\uff0c<\/span><\/strong>\u201c\u9605\u8bfb\u539f\u6587<\/span><\/strong>\u201d\u9884\u62a5\u540d<\/span><\/strong><\/span><\/em><\/p>\n


      <\/p>\n

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


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

      \u7814\u7f51\u57f9\u7b2c3\u671f\u66a8\u8bba\u575b\u603b\u7b2c9\u671f 2019\u5206\u6790\u65b9\u6cd5\u8f6c\u79fb\u6cd5\u89c4\u4ecb\u7ecd\u4e0e\u6848\u4f8b\u5206\u6790 \u65f6\u95f4\uff1a2019\u5e7405\u670808–1 […]<\/p>\n","protected":false},"author":1,"featured_media":78519,"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\/78518"}],"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=78518"}],"version-history":[{"count":1,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/78518\/revisions"}],"predecessor-version":[{"id":78527,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/78518\/revisions\/78527"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media\/78519"}],"wp:attachment":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media?parent=78518"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/categories?post=78518"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/tags?post=78518"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}