{"id":114930,"date":"2019-06-11T12:15:24","date_gmt":"2019-06-11T04:14:34","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/114930\/"},"modified":"2019-06-11T12:14:44","modified_gmt":"2019-06-11T04:14:44","slug":"8171b76122","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/114930\/","title":{"rendered":"6\u6708\u5f90\u5dde\uff0c\u9080\u60a8\u805a\u7126\u5168\u7403\u836f\u5178\u65b0\u52a8\u6001"},"content":{"rendered":"
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\u4f1a\u8bae\u5c06\u9080\u8bf7\u4e16\u754c\u536b\u751f\u7ec4\u7ec7\uff08WHO\uff09\u3001\u7f8e\u56fdFDA\u9a7b\u534e\u673a\u6784\u3001\u6b27\u6d32\u836f\u54c1\u8d28\u91cf\u7ba1\u7406\u5c40\uff08EDQM\uff09\u3001\u82f1\u56fd\u836f\u5178\u59d4\u5458\u4f1a\uff08BP\uff09\u3001\u7f8e\u56fd\u836f\u5178\u59d4\u5458\u4f1a\uff08USP\uff09\u7b49\u673a\u6784\u8d1f\u8d23\u4eba\uff0c\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\u6709\u5173\u9886\u5bfc\uff0c\u98df\u54c1\u836f\u54c1\u5ba1\u6838\u67e5\u9a8c\u4e2d\u5fc3\u3001\u4e0a\u6d77\u5e02\u836f\u54c1\u5ba1\u8bc4\u67e5\u9a8c\u4e2d\u5fc3\u3001\u6df1\u5733\u5e02\u836f\u54c1\u68c0\u9a8c\u7814\u7a76\u9662\u4ee5\u53ca\u6709\u5173\u4f01\u4e1a\u7684\u4e13\u5bb6\u548c\u4ee3\u8868\u56f4\u7ed5\u4f1a\u8bae\u4e3b\u9898\u8fdb\u884c\u62a5\u544a\uff0c\u5168\u9762\u4ecb\u7ecd\u5404\u56fd\u836f\u5178\u6807\u51c6\u5236\u5b9a\u7684\u6700\u65b0\u52a8\u6001\uff0c\u89e3\u8bfb\u5404\u56fd\u836f\u54c1\u6807\u51c6\u8ba4\u8bc1\u7684\u5ba1\u8bc4\u6d41\u7a0b\u548c\u6280\u672f\u8981\u6c42\uff0c\u8bb2\u89e3WHO\u5b9e\u9a8c\u5ba4\u9884\u8ba4\u8bc1\u7684\u5de5\u4f5c\u6d41\u7a0b\uff0c\u4ea4\u6d41\u836f\u54c1\u73b0\u573a\u68c0\u67e5\u4e2d\u6807\u51c6\u6267\u884c\u7684\u95ee\u9898\uff0c\u5206\u4eab\u5236\u836f\u4f01\u4e1a\u5728\u836f\u54c1\u3001\u539f\u6599\u836f\u3001\u836f\u7528\u8f85\u6599\u7533\u8bf7\u56fd\u9645\u836f\u5178\u673a\u6784\u8ba4\u8bc1\u7684\u7ecf\u9a8c\u3002<\/p>\n


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Zhang Wei has been the Secretary General of Chinese Pharmacopoeia Commission(ChPC) since January 2013. Prior to joining ChPC, he had been the director-general of department of Drug Registration of the State Food and Drug Administration in china from February 2006 to December 2012, the deputy director of Beijing Drug Administration and Director of Beijing Institute of Drug Control, deputy director of Division of Drug Administration of Beijing Bureau of Public Health.<\/p>\n<\/section>\n<\/section>\n<\/section>\n

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Sabine Kopp<\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n

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Sabine Kopp\u662f\u4e16\u754c\u536b\u751f\u7ec4\u7ec7(WHO)\u836f\u54c1\u8d28\u91cf\u4fdd\u8bc1\u5c0f\u7ec4\u7684\u8d1f\u8d23\u4eba\u3002\u5728\u4e16\u536b\u7ec4\u7ec7\u7684\u591a\u4e2a\u804c\u4f4d\u4e2d\uff0c\u5979\u66fe\u62c5\u4efbINN\u9879\u76ee\u79d8\u4e66\u3001\u836f\u54c1\u8d28\u91cf\u4fdd\u8bc1\u548c\u5b89\u5168\u4ee3\u7406\u5c0f\u7ec4\u534f\u8c03\u5458\u3001\u8d28\u91cf\u4fdd\u8bc1\u548c\u6253\u5047\u9879\u76ee\u9879\u76ee\u7ecf\u7406\uff0c\u56fd\u9645\u533b\u7597\u4ea7\u54c1\u9632\u4f2a\u5de5\u4f5c\u7ec4(IMPACT)\u4ee3\u7406\u79d8\u4e66\uff0c\u5e76\u79ef\u6781\u53c2\u4e0e\u4e16\u536b\u7ec4\u7ec7\u6210\u5458\u56fd\u5173\u4e8e\u52a3\u8d28\/\u5047\u5192\/\u5047\u6807\u7b7e\/\u4f2a\u9020\/\u5047\u5192\u533b\u7597\u4ea7\u54c1\u7684\u534f\u8c03\u673a\u5236\u3002<\/p>\n

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Sabine\u535a\u58eb\u662fWHO\u5236\u5242\u89c4\u8303\u4e13\u5bb6\u59d4\u5458\u4f1a\u8d1f\u8d23\u4eba\uff0c\u8d1f\u8d23\u534f\u8c03\u6d3b\u52a8\u7684\u76f8\u5173\u56fd\u9645\u6307\u5357\u7684\u5f00\u53d1\u548c\u7ef4\u62a4\uff0c\u6807\u51c6\u548c\u89c4\u8303\u836f\u54c1\u8d28\u91cf\u4fdd\u8bc1\u548c\u76f8\u5173\u56fd\u9645\u836f\u5178\uff0c\u4ece\u4e8b\u89c4\u8303\u836f\u54c1\u8d28\u91cf\u4fdd\u8bc1\u5de5\u4f5c\uff0c\u89c4\u8303\u4ece\u5f00\u53d1\u548c\u5236\u9020\u5230\u836f\u54c1\u7684\u5206\u9500\u548c\u4f9b\u5e94\u3002\u5979\u8d1f\u8d23\u76d1\u7763\u4e16\u536b\u7ec4\u7ec7\u8d28\u91cf\u63a7\u5236\u5b9e\u9a8c\u5ba4\u5916\u90e8\u8d28\u91cf\u4fdd\u8bc1\u8bc4\u4f30\u8ba1\u5212\uff0cSabine\u535a\u58eb\u62c5\u4efb\u4e16\u754c\u836f\u5178\u56fd\u9645\u4f1a\u8bae\u79d8\u4e66\uff0c\u5e76\u79ef\u6781\u53c2\u4e0e\u4e16\u536b\u7ec4\u7ec7\u65e8\u5728\u4fc3\u8fdb\u5168\u7403\u836f\u7269\u8d28\u91cf\u4fdd\u8bc1\u7684\u534f\u540c\u548c\u878d\u5408\u7684\u5404\u79cd\u6d3b\u52a8\u3002<\/p>\n

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Sabine Kopp is the Lead of the World Health Organization\u2019s (WHO) Medicines Quality Assurance group.  Among the various positions she held in WHO she was Secretary for the International Nonproprietary Names (INN) Programme, Acting Team Coordinator for Quality Assurance and Safety of Medicines, Programme Manager for the Quality Assurance and the Anticounterfeiting programmes, Acting Secretary of the International Medical Products Anti-Counterfeiting Taskforce (IMPACT) and was also actively involved in the WHO Member State mechanism on Substandard\/spurious\/falsely-labelled\/falsified\/counterfeit medical products.  <\/p>\n

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Sabine Kopp is Secretary of the WHO Expert Committee on Specifications for Pharmaceutical Preparations and is responsible for the coordination of WHO’s activities related to the development and maintenance of international guidelines, GXPs, standards and norms related to Medicines Quality Assurance and the International Pharmacopoeia, i.e. the normative work related to Medicines Quality Assurance within WHO, spanning from development and manufacturing to the distribution and supply of the medicines. She is overseeing WHO\u2019s External Quality Assurance Assessment Scheme for quality control laboratories, serving as Secretary the international meetings of world pharmacopoeias and involved in WHO activities aimed at enabling synergies and convergence in medicines quality assurance globally.<\/p>\n


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James Pound \u82f1\u56fd\u836f\u5178\u59d4\u5458\u4f1a\u79d8\u4e66\u957f\uff08\u4e3b\u4efb\uff09\uff0c\u4ed6\u4e8e2008\u5e74\u52a0\u5165\u82f1\u56fd\u836f\u54c1\u4e0e\u4fdd\u5065\u54c1\u7ba1\u7406\u5c40\u3002\u66fe\u5728\u82f1\u56fd\u836f\u5178(BP)\u53ca\u5b9e\u9a8c\u5ba4\u62c5\u4efb\u591a\u4e2a\u804c\u4f4d\uff0c\u5e76\u4e8e2017\u5e74\u664b\u5347\u4e3a\u82f1\u56fd\u836f\u5178\u4f1a\u79d8\u4e66\u957f\uff08\u4e3b\u4efb\uff09\u3002<\/p>\n

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\u4f5c\u4e3a\u82f1\u56fd\u836f\u5178\u7684\u8d1f\u8d23\u4eba\uff0c\u4ed6\u8d1f\u8d23\u836f\u5178\u548c\u8be5\u673a\u6784\u7684\u76d1\u7ba1\u4ee5\u53ca\u5b9e\u9a8c\u5ba4\u68c0\u6d4b\u6d3b\u52a8\u3002James Pound\u62e5\u6709\u5316\u5b66\u8363\u8a89\u5b66\u4f4d\uff0c\u6b64\u524d\u66fe\u5728\u5168\u7403\u5236\u836f\u4f01\u4e1a\u62c5\u4efb\u5206\u6790\u5316\u5b66\u65b9\u9762\u7684\u591a\u4e2a\u804c\u4f4d\u3002<\/p>\n

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James Pound joined the UK\u2019s Medicines and Healthcare Products Regulatory Agency (MHRA) in 2008. He has worked in a variety of roles within the British Pharmacopoeia (BP) & Laboratory Services Group and in 2017 was promoted to the role of Group Manager British Pharmacopoeia & Laboratory Services, and Secretary & Scientific Director of the BP Commission.<\/p>\n

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He is a senior leader within the Agency and has responsibility for both the pharmacopoeia and the Agency\u2019s regulatory laboratory testing activities. He holds an honours degree in Chemistry and has previously worked in a variety of roles focused on analytical chemistry for global pharmaceutical manufacturers.<\/p>\n


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\u8463\u6c5f\u840d\u5973\u58eb\uff0c\u4e3b\u4efb\u836f\u5e08\uff0c\u56fd\u5bb6\u836f\u76d1\u5c40\u98df\u54c1\u836f\u54c1\u5ba1\u6838\u67e5\u9a8c\u4e2d\u5fc3\u526f\u4e3b\u4efb\u3002<\/p>\n


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2000\u5e7410\u6708-2011\u5e7411\u6708\uff0c\u5c31\u804c\u4e8e\u539f\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\u836f\u54c1\u5ba1\u8bc4\u4e2d\u5fc3\uff0c\u5386\u4efb\u836f\u5b66\u4e13\u4e1a\u5ba1\u8bc4\u5458\u3001\u5ba1\u8bc4\u7ba1\u7406\u4e0e\u534f\u8c03\u90e8\u526f\u90e8\u957f\u3001\u4fe1\u606f\u90e8\u90e8\u957f\uff1b2011\u5e7412\u6708\u81f32016\u5e743\u6708\uff0c\u5148\u540e\u5c31\u804c\u4e8e\u539f\u56fd\u5bb6\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\u3001\u539f\u56fd\u5bb6\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u603b\u5c40\u30022016\u5e743\u6708\u81f3\u4eca\u4efb\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\u98df\u54c1\u836f\u54c1\u5ba1\u6838\u67e5\u9a8c\u4e2d\u5fc3\u526f\u4e3b\u4efb\u3002<\/p>\n

 <\/p>\n

 <\/p>\n

Ms. Jiangping Dong, Deputy General Director for CFDI(Center for Food and Drug inspection of NMPA ).<\/p>\n


<\/p>\n

From October 2000 to December 2011, worked in the Drug Evaluation Center as pharmaceutical professional assessor, deputy director of the assessment management and coordination department, director of the information department. From December 2011 to March 2016, worked in the  SFDA and CFDA. Since March 2016, she has been the deputy director of the food and drug inspection center of NMPA.<\/p>\n


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

\n
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\"6\u6708\u5f90\u5dde\uff0c\u9080\u60a8\u805a\u7126\u5168\u7403\u836f\u5178\u65b0\u52a8\u6001\"<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n
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Gabriel Giancaspro<\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n

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

\n
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Giancaspro\u535a\u58eb\u662f\u7f8e\u56fd\u836f\u5178\uff08USP\uff09\u81b3\u98df\u8865\u5145\u5242\u548c\u8349\u836f\u79d1\u5b66\u90e8\u526f\u603b\u88c1\u3002\u4ed6\u7684\u90e8\u95e8\u5411\u8d1f\u8d23\u5236\u5b9a\u7f8e\u56fd\u836f\u5178\u81b3\u98df\u8865\u5145\u5242\u3001\u8349\u836f\u548c\u98df\u54c1\u6210\u5206\u6807\u51c6\u7684\u4e13\u5bb6\u59d4\u5458\u4f1a\u63d0\u4f9b\u652f\u6301\u3002<\/p>\n

 <\/p>\n

\u5728\u6b64\u4e4b\u524d\uff0c\u4ed6\u66fe\u62c5\u4efbUSP\u6587\u732e\u6807\u51c6\u90e8\u81b3\u98df\u8865\u5145\u5242\u4e3b\u7ba1\uff0c\u8d1f\u8d23\u690d\u7269\u548c\u975e\u690d\u7269\u81b3\u98df\u8865\u5145\u5242\u4e13\u8457\u548c\u901a\u5219\u7684\u5f00\u53d1\uff0c\u5b89\u5168\u6027\u8bc4\u4f30\uff0c\u6027\u80fd\u6807\u51c6\u4ee5\u53caUSP\u81b3\u98df\u8865\u5145\u5242\u7eb2\u8981\u7684\u51fa\u7248\u3002<\/p>\n

 <\/p>\n

\u5728\u52a0\u5165USP\u4e4b\u524d\uff0cGiancaspro\u535a\u58eb\u5728\u5e03\u5b9c\u8bfa\u65af\u827e\u5229\u65af\u5927\u5b66\u836f\u5b66\u9662\u8d1f\u8d23\u836f\u7269\u5316\u5b66\u3001\u836f\u7269\u5206\u6790\u548c\u836f\u7269\u7a33\u5b9a\u6027\u7684\u6559\u5b66\u548c\u7814\u7a76\u3002\u4ed6\u8fd8\u62e5\u6709\u4e30\u5bcc\u7684\u884c\u4e1a\u7ecf\u9a8c\uff0c\u66fe\u4efb\u91cc\u683c\u8f9b\u3001\u65bd\u74e6\u8d1d-\u963f\u6839\u5ef7\u548c\u574e\u4f69\u5c14\u9a6c\u8482\u5b89\u516c\u53f8\u6280\u672f\u603b\u76d1\uff0c\u8d1f\u8d23\u76d1\u7ba1\u4e8b\u52a1\u3001\u5206\u6790\u7814\u7a76\u548c\u5f00\u53d1\uff0c\u4ee5\u53ca\u5bf9\u80a0\u5916\u6ce8\u5c04\u7269\u3001\u8349\u836f\u548c\u80bf\u7624\u836f\u7269\u7684\u8d28\u91cf\u63a7\u5236\u3002<\/p>\n


<\/p>\n

Giancaspro\u535a\u58eb\u62e5\u6709\u836f\u5242\u5e08\u5b66\u4f4d\u548c\u963f\u6839\u5ef7\u5e03\u5b9c\u8bfa\u65af\u827e\u5229\u65af\u5927\u5b66\u7684\u836f\u5b66\uff08\u836f\u7269\u5316\u5b66\uff09\u535a\u58eb\u5b66\u4f4d\u3002<\/p>\n

 <\/p>\n

Dr. Giancaspro is the Vice President, Science\u2014Dietary Supplements and Herbal Medicines, for USP. His department provides staff support to Expert Committees responsible for setting USP\u2019s standards for dietary supplements, herbal medicines, and food ingredients.<\/p>\n

 <\/p>\n

Previously, he was the Director for Dietary Supplements in the Documentary Standards Division at USP responsible for the development of monographs and general chapters for botanical and non-botanical dietary supplements, safety evaluations, performance standards, and the publication of the USP Dietary Supplements Compendium.<\/p>\n

 <\/p>\n

Before joining USP, Dr. Giancaspro’s teaching and research experience included medicinal chemistry, drug analysis, and drug stability at the Pharmacy School at the University of Buenos Aires. He also has extensive industrial experience as the former Technical Director of Rigecin, Schwabe-Argentina and Kampel-Martian, in charge of Regulatory Affairs, Analytical Research and Development, and Quality Control of parenterals, herbal medicines, and oncological medicines.<\/p>\n

 <\/p>\n

Dr. Giancaspro holds a Pharmacist degree and a Ph.D. in pharmaceutical sciences (medicinal chemistry) from the University of Buenos Aires, Argentina.<\/p>\n


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

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\"6\u6708\u5f90\u5dde\uff0c\u9080\u60a8\u805a\u7126\u5168\u7403\u836f\u5178\u65b0\u52a8\u6001\"<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n
\n
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Pascale POUKENS-RENWART<\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n

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

\n
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Pascale POUKENS-RENWART \u535a\u58eb\u5728\u6bd4\u5229\u65f6\u5217\u65e5\u5927\u5b66\u5b66\u4e60\u836f\u5242\u5b66\u5e76\u83b7\u5f97\u4e86\u535a\u58eb\u5b66\u4f4d\uff0c\u5e76\u540c\u65f6\u57281988-1994\u5e74\u671f\u95f4\u62c5\u4efb\u7814\u7a76\u52a9\u7406\u3002\u5979\u62c5\u4efb\u7814\u7a76\u52a9\u7406\u3002<\/p>\n

 <\/p>\n

\u4ece1997\u5e74\u52302000\u5e74\uff0c\u5979\u62c5\u4efb\u6bd4\u5229\u65f6\u536b\u751f\u5c40\u7684\u5316\u5b66\u836f\u54c1\u8bc4\u4f30\u5458\uff0c\u8d1f\u8d23\u8d28\u91cf\u90e8\u5206\u7684\u8bc4\u4f30\u9500\u552e\u6388\u6743\u7533\u8bf7\u3002<\/p>\n

 <\/p>\n

2000\u5e74\uff0c\u5979\u52a0\u5165\u4e86\u6b27\u6d32\u836f\u54c1\u8d28\u91cf\u7ba1\u7406\u5c40(EDQM)\u7684\u8ba4\u8bc1\u90e8\u95e8\uff0c\u62c5\u4efb\u8be5\u90e8\u95e8\u7684\u79d1\u5b66\u5b98\u5458\uff0c\u8d1f\u8d23\u65b0\u7533\u8bf7\u7684\u8bc4\u5ba1\u5de5\u4f5c\u3002\u4ece2010\u5e74\u81f32017\u5e74\uff0c\u62c5\u4efb\u4fee\u8ba2\u90e8\u95e8\u4e3b\u4efb\u3002\u81ea2017\u5e74\u81f3\u4eca\uff0c\u62c5\u4efb\u8d28\u91cf\u4fdd\u8bc1\u548c\u8ba4\u8bc1\u90e8\u95e8\u4e3b\u4efb\u3002<\/p>\n

 <\/p>\n

Dr Pascale POUKENS-RENWART studied  Pharmacy  at  the University of Li\u00e8ge, Belgium. She obtained a PhD degree in  Pharmacogosy from the same  university  in 1994  where  she  worked as research assistant (1988-1994).<\/p>\n

 <\/p>\n

From 1997 to 2000 she was chemical-pharmaceutical  assessor  at  the Belgian  Health  Authorities  and  was  in  charge  of  the  evaluation of the quality part of  the  dossiers  for  marketing  authorisation applications.<\/p>\n

 <\/p>\n

Then in 2000, she joined the EDQM (European Directorate for the Quality of Medicines) in the Certification Department, as Scientific Officer in  charge of the assessment of new applications.<\/p>\n

 <\/p>\n

From 2010 to 2017 she was Head of the Revisions Section in the same Department. Since 2017 till now she is the Head of the Quality Assurance and Scientific  Support  Section from  the  Certification  Department.<\/p>\n


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

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\"6\u6708\u5f90\u5dde\uff0c\u9080\u60a8\u805a\u7126\u5168\u7403\u836f\u5178\u65b0\u52a8\u6001\"<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n
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\u6d2a\u5c0f\u6829<\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n

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

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\u6d2a\u5c0f\u6829\uff0c\u4efb\u56fd\u5bb6\u836f\u5178\u59d4\u5458\u4f1a\u4e1a\u52a1\u7efc\u5408\u5904\u5de5\u4f5c\u526f\u5904\u957f\uff0c\u8d1f\u8d23\u7ec4\u7ec72020\u5e74\u7248\u548c2015\u5e74\u7248\u300a\u4e2d\u56fd\u836f\u5178\u300b\u56db\u90e8\u7684\u7f16\u5236\u5de5\u4f5c\uff0c\u5305\u62ec\u51e1\u4f8b\u3001\u68c0\u9a8c\u65b9\u6cd5\u901a\u5219\u3001\u6307\u5bfc\u539f\u5219\u3001\u836f\u7528\u8f85\u6599\u548c\u836f\u5305\u6750\u76f8\u5173\u6807\u51c6\u3002\u5148\u540e\u53c2\u4e0e\u4e86\u300a\u4e2d\u56fd\u751f\u7269\u5236\u54c1\u89c4\u7a0b\u300b2000\u5e74\u7248\u3001\u300a\u4e2d\u56fd\u836f\u5178\u300b\u4e09\u90e82005\u5e74\u7248\u30012010\u5e74\u7248\u30012015\u5e74\u7248\u7684\u5236\u4fee\u8ba2\u5de5\u4f5c\u3002<\/p>\n

 <\/p>\n

 <\/p>\n

Dr. Hong works for the comprehansive department of Chinese Pharmacopoeia Commission and is responsible for developing the Chinese Pharmacopoeia volume IV 2015 and 2020 edition, including the general requirements, general chapter (testing methods), guidelines, pharmaceutical excipients as well as the drug package. worked for the biologics standards department of ChPC and participated the development of Ch.P Vol .III 2000, 2005, 2010 and 2015 edition.<\/p>\n


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

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

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\"6\u6708\u5f90\u5dde\uff0c\u9080\u60a8\u805a\u7126\u5168\u7403\u836f\u5178\u65b0\u52a8\u6001\"<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n
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Stephen W. Andruski<\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n

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

\n
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Steve\u62e5\u6709\u5a01\u65af\u5eb7\u8f9b\u5927\u5b66\u5bc6\u5c14\u6c83\u57fa\u5206\u6821\u5316\u5b66\u5b66\u58eb\u5b66\u4f4d\u3002\u6bd5\u4e1a\u540e\uff0c\u4ed6\u5148\u5c31\u804c\u4e8eAldrich\u5316\u5b66\u516c\u53f8\uff0c\u8d1f\u8d23\u65b0\u589e\u76ee\u5f55\u5316\u5408\u7269\u7684\u5c0f\u89c4\u6a21\u751f\u4ea7\u548c\u5de5\u827a\u5f00\u53d1\u3002\u968f\u540eSteve\u5728\u4e9a\u5229\u6851\u90a3\u5927\u5b66\u83b7\u5f97\u4e86\u6709\u673a\u5316\u5b66\u535a\u58eb\u5b66\u4f4d\u3002\u5728\u582a\u8428\u65af\u5927\u5b66\u5b8c\u6210\u535a\u58eb\u540e\u5de5\u4f5c\u540e\uff0cSteve\u52a0\u5165\u4e86\u5bcc\u7f8e\u5b9e\u516c\u53f8\uff08FMC\uff09\u7684\u5de5\u827a\u7814\u53d1\u7ec4\uff0c\u4ece\u4e8b\u65b0\u578b\u519c\u836f\u7684\u5de5\u827a\u7814\u53d1\uff0c\u652f\u6301\u6cd5\u89c4\u6ce8\u518c\uff0c\u5e76\u9886\u5bfc\u6742\u8d28\u5408\u6210\u5b9e\u9a8c\u5ba4\u3002\u5728FMC\u5de5\u4f5c\u4e86\u8fd1\u5341\u5e74\u540e\uff0cSteve\u52a0\u5165\u4e86\u5965\u5c14\u5df4\u5c3c\u5206\u5b50\u7814\u7a76\u516c\u53f8\uff08AMRI\uff09\u7684\u5316\u5b66\u5f00\u53d1\u5c0f\u7ec4\uff0c\u4e3aGMP\u5408\u6210\u4e34\u5e8a\u8bd5\u9a8c\u539f\u6599\u836f\u5f00\u5c55\u5c0f\u89c4\u6a21\u5b9a\u5236\u5408\u6210\u3001\u5408\u6210\u8def\u7ebf\u63a2\u7d22\u548c\u89c4\u6a21\u5316\u751f\u4ea7\u3002Steve\u968f\u540e\u8fdb\u5165\u5206\u6790\u90e8\u95e8\uff0c\u8d1f\u8d23\u65b9\u6cd5\u5f00\u53d1\u3001\u65b9\u6cd5\u9a8c\u8bc1\u548cGMP\u751f\u4ea7\uff0c\u5728AMRI\u5927\u578bGMP\u751f\u4ea7\u5de5\u5382\u9886\u5bfc\u4e00\u4e2a\u75316\u540d\u5206\u6790\u5e08\u7ec4\u6210\u7684\u56e2\u961f\u3002<\/p>\n

 <\/p>\n

\u5728AMRI\u5de5\u4f5c12\u5e74\u540e\uff0c\u7ed3\u5408\u4e86\u4ed6\u6240\u5177\u5907\u7684\u5408\u6210\u3001\u5de5\u827a\u548c\u5206\u6790\u5316\u5b66\u80cc\u666f\uff0c\u4ee5\u53ca\u4ed6\u5bf9GMP\u6cd5\u89c4\u548c\u8d28\u91cf\u539f\u5219\u7684\u719f\u6089\u7a0b\u5ea6\uff0cSteve\u52a0\u5165USP\u6210\u4e3a\u8ba4\u8bc1\u9879\u76ee\u9ad8\u7ea7\u7ecf\u7406\u3002<\/p>\n

 <\/p>\n

Steve received his BS in Chemistry from the University of Wisconsin \u2013 Milwaukee.  After graduating, he worked at Aldrich Chemical Company doing small-scale production and process development for new catalog compounds.  Steve subsequently obtained his PhD from the University of Arizona in Organic Chemistry.  Following post-doctoral work at the University of Kansas, Steve joined the Process Research group at FMC Corporation performing process R&D on novel pesticides, supporting regulatory registrations and leading lab work on the synthesis of impurities.  After nearly ten years at FMC, Steve left to join the rapidly-growing contract research organization AMRI, initially in the Chemical Development group working on small-scale custom synthesis, route-scouting and scale-up work for the GMP synthesis of clinical trial APIs.  Steve then moved into the Analytical Department performing method development, method validation and support of GMP production, eventually leading a group of six analysts at AMRI\u2019s large-scale GMP manufacturing facility. <\/p>\n


<\/p>\n

After almost twelve years with AMRI, Steve left to join the Verification Program staff at the US Pharmacopeia where he is currently a Senior Manager.  This position combines Steve\u2019s synthetic, process and analytical chemistry background, and his familiarity with GMP regulations and quality principles.<\/p>\n


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\"6\u6708\u5f90\u5dde\uff0c\u9080\u60a8\u805a\u7126\u5168\u7403\u836f\u5178\u65b0\u52a8\u6001\"<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n
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\u6d82\u5bb6\u751f<\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n

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

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\u6d82\u5bb6\u751f\uff0c\u4e2d\u56fd\u836f\u79d1\u5927\u5b66\u836f\u5242\u5b66\u6559\u6388\u3001\u535a\u58eb\u751f\u5bfc\u5e08\uff0c\u56fd\u5bb6\u836f\u5178\u59d4\u5458\u4f1a\u59d4\u5458\u3001\u6267\u884c\u59d4\u5458\uff08\u836f\u7528\u8f85\u6599\u548c\u5305\u6750\u59d4\u5458\u4f1a\u4e3b\u4efb\uff09\u3001\u56fd\u5bb6\u836f\u54c1\u5ba1\u8bc4\u4e13\u5bb6\u3001\u7f8e\u56fd\u836f\u5178\u4f1a\u8f85\u6599\u6b63\u6587\u4e13\u4e1a\u59d4\u5458\u4f1a\u59d4\u5458\u3001\u4e2d\u56fd\u836f\u5b66\u4f1a\u5236\u5242\u59d4\u5458\u4f1a\u59d4\u5458\uff1b\u300a\u836f\u7269\u751f\u7269\u6280\u672f\u300b\u3001Asian Journal of Pharmaceutical Sciences\u3001\u4e2d\u56fd\u65b0\u836f\u6742\u5fd7\u3001\u4e2d\u56fd\u836f\u54c1\u6807\u51c6\u7f16\u59d4\u3002<\/p>\n

 <\/p>\n

\u5148\u540e\u5728\u5317\u4eac\u533b\u79d1\u5927\u5b66\uff081981-1986\uff0c\u83b7\u5b66\u58eb\u5b66\u4f4d\uff09\u3001\u4e2d\u56fd\u836f\u79d1\u5927\u5b66\uff081986-1992\uff0c\u83b7\u535a\u58eb\u5b66\u4f4d\uff09\u5b66\u4e60\u3002\u4e00\u76f4\u5728\u4e2d\u56fd\u836f\u79d1\u5927\u5b66\u4ece\u4e8b\u836f\u5242\u5b66\u6559\u5b66\u3001\u79d1\u7814\u5de5\u4f5c\u3002\u8fd1\u5e74\u6765\uff0c\u4e3b\u6301\u548c\u53c2\u52a0\u79d1\u6280\u90e8\u79d1\u6280\u652f\u6491\u8ba1\u5212\u201c\u6ce8\u5c04\u7528\u836f\u7528\u8f85\u6599\u7684\u5b89\u5168\u6027\u548c\u8d28\u91cf\u201d\u3001\u81ea\u7136\u79d1\u5b66\u57fa\u91d1\u9879\u76ee\u201c\u80bf\u7624\u9776\u5411\u7684SiRNA\u4f20\u9012\u8f7d\u4f53\u7684\u8bbe\u8ba1\u548c\u8bc4\u4ef7\u201d\u3001\u56fd\u5bb6115\u836f\u7269\u5236\u5242\u521b\u65b0\u5e73\u53f0\u201c\u6280\u672f\u5e73\u53f0\u5efa\u8bbe\u201d\u3001\u56fd\u5bb6125\u91cd\u5927\u4e13\u9879\u201cmPEG-PDLLA\u7684\u5e94\u7528\u5173\u952e\u6280\u672f\u201d\u548c\u56fd\u5bb6\u836f\u5178\u59d4\u5458\u4f1a\u836f\u7528\u8f85\u6599\u6807\u51c6\u63d0\u9ad8\u8ba1\u5212\u3001\u56fd\u5bb6\u836f\u54c1\u5ba1\u8bc4\u4e2d\u5fc3\u6280\u672f\u652f\u6491\u8ba1\u5212\u3001\u56fd\u5bb6\u65b0\u836f\u521b\u5236\u91cd\u5927\u4e13\u9879\u201c\u53e3\u670d\u5236\u5242\u8d28\u91cf\u548c\u7597\u6548\u4e00\u81f4\u6027\u201d\u7b49\u7eb5\u5411\u9879\u76ee\u3002\u5e76\u4e3b\u6301\u591a\u9879\u65b0\u836f\u3001\u65b0\u5242\u578b\u7684\u7814\u53d1\u3002<\/p>\n

 <\/p>\n

Jiasheng Tu is the professor of pharmaceutics of China Pharmaceutical University, a supervisor of doctorate students. Dr. Tu has also served as the chair of CHP pharmaceutical excipient committee, an expert committee member of CHP, an expert committee member of pharmaceutical excipient of USP.<\/p>\n

 <\/p>\n

Dr. Tu graduated from Beijing Medical University. He was awarded Ph.D. of pharmaceutics in China Pharmaceutical University at 1992 and did postdoctoral researches in University of the Pacific, CA, during 2001-2003. <\/p>\n

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\u674e\u6c5f\u5b81<\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n

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\u674e\u6c5f\u5b81\uff0c\u6c49\u65cf\uff0c\u4e2d\u5171\u515a\u5458\uff0c\u6267\u4e1a\u836f\u5e08\uff0c\u526f\u4e3b\u4efb\u836f\u5e08\u3002\u4e2d\u56fd\u836f\u79d1\u5927\u5b66\u5fae\u751f\u7269\u5236\u836f\u4e13\u4e1a\u6bd5\u4e1a\uff0c\u5de5\u5b66\u5b66\u58eb\u30022007\u5e74\u83b7\u5916\u4ea4\u5b66\u9662\u6cd5\u5b66\u7855\u58eb\u5b66\u4f4d\uff0c\u56fd\u5bb6\u836f\u54c1GSP\u8ba4\u8bc1\u68c0\u67e5\u5458\uff0c\u56fd\u5bb6\u836f\u54c1GMP\u9ad8\u7ea7\u8ba4\u8bc1\u68c0\u67e5\u5458\uff0c\u66fe\u4efb\u539f\u5317\u4eac\u5e02\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\u6d77\u6dc0\u5206\u5c40\u526f\u5c40\u957f\u3001\u539f\u5317\u4eac\u5e02\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\u836f\u54c1\u533b\u7597\u5668\u68b0\u6d41\u901a\u5904\u5904\u957f\uff0c\u73b0\u4efb\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\u836f\u54c1\u6ce8\u518c\u7ba1\u7406\u53f8\u7efc\u5408\u5904\u5904\u957f\u3002<\/p>\n

 <\/p>\n

\u674e\u6c5f\u5b81\u957f\u671f\u4ece\u4e8b\u836f\u54c1\u548c\u533b\u7597\u5668\u68b0\u76d1\u7ba1\u5de5\u4f5c\uff0c\u81ea2017\u5e74\u5f00\u59cb\u5168\u9762\u53c2\u4e0e\u836f\u54c1\u5ba1\u8bc4\u5ba1\u6279\u5236\u5ea6\u6539\u9769\u5de5\u4f5c\uff0c\u5bf9\u836f\u54c1\u76d1\u7ba1\u5de5\u4f5c\u548c\u836f\u54c1\u5ba1\u8bc4\u5ba1\u6279\u5236\u5ea6\u6539\u9769\u6709\u7740\u8f83\u4e3a\u7cfb\u7edf\u7684\u4e86\u89e3\u3002<\/p>\n

 <\/p>\n

Mr. Jiangning Li, Pharmacist, graduated from China Pharmaceutical University majoring in microorganism pharmacy. In 2007, he received his Master’s degree in law from China Foreign Affairs University.<\/p>\n

 <\/p>\n

He is the national drug GSP certification inspectors, senior national drug GMP certification inspectors. Former Deputy Director of the Drug Administration of Beijing Haidian District and Director of medical equipment of Beijing Drug Administration. His current position is Director of General Office of Drug and Cosmetics Registration Division of NMPA.<\/p>\n


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

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Howard Sklamberg<\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n

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Howard Sklamberg\u5148\u751f\u662fAkin Gump Strauss Hauer & Feld LLP\u5f8b\u6240\u7684\u5408\u4f19\u4eba\u30022014\u5e744\u6708\u81f32017\u5e744\u6708\uff0c\u4ed6\u62c5\u4efb\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u7ba1\u7406\u5c40\u526f\u5c40\u957f\uff0c\u4e3b\u8981\u8d1f\u8d23\u5168\u7403\u76d1\u7ba1\u4e1a\u52a1\u548c\u653f\u7b56\uff0c\u8d1f\u8d23\u76d1\u7ba1\u4e8b\u52a1\u529e\u516c\u5ba4\u548c\u56fd\u9645\u9879\u76ee\u529e\u516c\u5ba4\u3002\u4ed6\u9886\u5bfc\u6216\u5171\u540c\u9886\u5bfc\u4e86\u8bb8\u591a\u8d28\u91cf\u548c\u5b89\u5168\u65b9\u9762\u7684\u5de5\u4f5c(\u5305\u62ec\u836f\u54c1\u68c0\u9a8c\u73b0\u4ee3\u5316\u7b49)\u3001\u6267\u6cd5\u653f\u7b56\u3001\u8c08\u5224\u548c\u5b9e\u65bd\uff0c\u4ee5\u53ca\u8fdb\u53e3\u5b9e\u65bd\u7b49\u3002\u5e76\u9886\u5bfc\u4e86FDA\u7684\u5168\u7403\u548c\u591a\u8fb9\u5408\u4f5c\u53ca\u5176\u6d77\u5916\u529e\u4e8b\u5904\uff0c\u5305\u62ec\u4e2d\u56fd\u529e\u4e8b\u5904\u3002Howard Sklamberg\u5148\u751f\u8fd8\u66fe\u62c5\u4efb\u836f\u7269\u8bc4\u4ef7\u548c\u7814\u7a76\u4e2d\u5fc3\u4e3b\u4efb\u4ee5\u53ca\u76d1\u7ba1\u4e8b\u52a1\u90e8\u526f\u5c40\u957f\u3002<\/p>\n

 <\/p>\n

Howard Sklamberg is a partner at Akin Gump Strauss Hauer & Feld LLP. From 2014-April 2017, Howard served as USFDA\u2019s Deputy Commissioner for Global Regulatory Operations and Policy, where he oversaw the Office of Regulatory Affairs and the Office of International Programs. He led or co-led many quality and safety efforts (including drug inspection modernization and program alignment), enforcement policy, the negotiation and implementation of user fees, and import enforcement. Howard directed FDA\u2019s global and multilateral initiatives and its overseas offices, including its China Office.  Howard also served as Director of the Center for Drug Evaluation and Research\u2019s Office of Compliance and Deputy Associate Commissioner for Regulatory Affairs.<\/p>\n

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\u9648\u6842\u826f<\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n

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 <\/p>\n

Dr. Chen Guiliang is the director of Shanghai Center for Drug Evaluation and Inspection. He is a member of Chinese Pharmacopoeia Commission. He is also an advanced member of the Committee of Pharmaceutical Analysis in China Pharmaceutical Association. Dr. Chen has taken part in edit of 9 separate books. Till now he has had more than 160 research papers published in domestic and foreign journals. He is an editorial member of several Chinese Journals. He has been in charge of several scientific projects of Shanghai Science & Technology Committee and Chinese Pharmacopoeia Commission. Dr. Chen has long been specializing in the research of pharmaceutical quality standard, the establishment of in vitro\/in vivo evaluation of inhalers, drug evaluation and inspection, etc.<\/p>\n


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 <\/p>\n

Wang Xiaowei, Ph.D., Chief Pharmacist, Deputy Director of Shenzhen Institute for Drug Control (SZIDC), Quality Manager. She has been engaged in drugs, medical devices, health food, cosmetics related testing work for 23 years, with a wealth of laboratory management, testing technique and method research experience; She is WHO RSS Medicines Quality Control Laboratories(QCL) Peer Auditor, CNAS and CMA laboratory inspector, GMP inspector; She was invited to join in WHO prequalification team peer audit mission of Zambia Medicines Regulatory Authority(ZAMRA) QCL, Lusaka, Zambia in 2016, and Dalian Institute for Drug Control(DIDC), Dalian, China in 2019, and was invited to attend and address the 4th, the 5th and the 6th WHO Interregional Seminar for QCL involved in the WHO Prequalification.<\/p>\n


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\u4e01\u6069\u5cf0\uff0c\u62c5\u4efb\u4e0a\u6d77\u590d\u661f\u533b\u836f\u4ea7\u4e1a\u53d1\u5c55\u6709\u9650\u516c\u53f8\u526f\u603b\u7ecf\u7406\uff0c\u540c\u65f6\u62c5\u4efbMAH QP\u3002\u5177\u6709\u591a\u5e74\u65e0\u83cc\u5236\u836f\u884c\u4e1a\u5de5\u4f5c\u7ecf\u9a8c\uff0c\u8d44\u6df1\u65e0\u83cc\u5236\u836f\u6280\u672f\u4e13\u5bb6\u3002<\/p>\n

 <\/p>\n

He services as the deputy general manager of Shanghai Fosun Pharmaceutical Industry Development Co., Ltd., and also served as MAH QP.He is senior sterile pharmaceutical technology expert\uff0cand has many years of experience in the aseptic pharmaceutical industry.<\/p>\n


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Ms. XIE Hongyan(Master\u2019s degree for pharmaceutical chemistry&Bachelor\u2019s degree for pharmacology; senior engineer, licensed pharmacist) graduated from Shanghai Medical University in 1994. She worked in production and quality control department from1994 to 1996 and was involved in the construction of QiluAntibioticos Joint Venture from 1996 to 1997. She was trained for drug quality control and management in Antibioticos Italy in 1997. She worked as QC laboratory supervisor(1998~1999) and Quality Assurance Director(1999~2005) in QiluAntibioticos Pharmaceutical Co., Ltd. and was also responsible for the product registration in both China and other countries. Then she worked as Deputy General Manager for Quality(2005~2007)andDeputy General Manager for Overseas Regulatory Affairs(2007~2017) in Qilu Pharmaceutical Co., Ltd. She has been working as Vice President in QiluPharma Group( in charge of overseas regulatory affairs and internal quality audit of Qilu group) since 2018. She has working experiences for quality control and management, overseas registration and inspection for API and finished dosage forms in the pharmaceutical industry. <\/p>\n<\/section>\n<\/section>\n<\/section>\n

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