关于加强药品检查员队伍建设的思考
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摘要
目的探讨加强我国药品检查员队伍建设的方法和路径。方法通过梳理和总结美国FDA药品检查员队伍的情况及启示,结合我国药品检查员相关情况展开一系列调研,深入剖析当前我国药品检查员建设中存在的问题。结果对我国药品检查员队伍建设提供方法和思路。结论我国药品检查员队伍建设应采取远近结合、分步解决的模式。从长远看,职业化是方向;从近期看,在职业化实现之前,检查员建设应以解决专业化为主,走专兼职结合的道路。同时,要突出药品检查的专业性、技术性特点,体现药品"高精尖"技术水平,建设国家、省两级职业化检查员队伍。在检查员队伍人员来源的考虑上,建议将检查员的聘用放眼到系统外第三方,并充分发挥各地药品职业学院作用,从中有针对性地培养检查员潜在队伍。
OBJECTIVE To explore ways and paths to strengthen team building of China's drug inspectors. METHODS By analyzing and summarizing the experience and enlightenment of the US FDA' s drug inspector team,a series of research are launched considering current situation of drug inspectors,and problems in the China's drug inspector team building are analyzed in depth. RESULTS It is to provide approaches and methods for the construction of China's drug inspection team. CONCLUSION The construction of China's drug inspection team should combine both long-term and short-term considerations and solve problems step by step.In the long run,professionalism is the orientation. In the near future,before realization of professionalism,the construction of drug inspectors should focus on specialization and develop full-time and part-time inspectors. At the same time,it is necessary to highlight the professional and technical characteristics of drug inspection,reflect the " high-precision" technical level of drugs,and build a team of professional inspectors at the national and provincial levels. In the consideration of the source of the inspectors,it is recommended that the inspectors to be hired from the third party outside the supervision system,and let local pharmaceutical vocational colleges play great roles to develop potential teams of inspectors.
OBJECTIVE To explore ways and paths to strengthen team building of China's drug inspectors. METHODS By analyzing and summarizing the experience and enlightenment of the US FDA' s drug inspector team,a series of research are launched considering current situation of drug inspectors,and problems in the China's drug inspector team building are analyzed in depth. RESULTS It is to provide approaches and methods for the construction of China's drug inspection team. CONCLUSION The construction of China's drug inspection team should combine both long-term and short-term considerations and solve problems step by step.In the long run,professionalism is the orientation. In the near future,before realization of professionalism,the construction of drug inspectors should focus on specialization and develop full-time and part-time inspectors. At the same time,it is necessary to highlight the professional and technical characteristics of drug inspection,reflect the " high-precision" technical level of drugs,and build a team of professional inspectors at the national and provincial levels. In the consideration of the source of the inspectors,it is recommended that the inspectors to be hired from the third party outside the supervision system,and let local pharmaceutical vocational colleges play great roles to develop potential teams of inspectors.
引文
[1]General office of the cpc central committee.General office of the state council.Opinions on deepening the reform of the review and approval system and encouraging drug and medical device innovation[EB/OL](2018-07-16)[2017-04-18].http://www.gov.cn/xinwen/2017-10/08/content_5230105.htm.
[2]DENG T.Research on countermeasures of construction of the state professional inspector team of drug based on the successful experience of mayo clinic[J].China Licensed Pharm(中国执业药师),2016,(9):33-39.
[3]HUANG W H,TIAN S L,DONG J P,et al.Inspector training system and its enlightenment on the improvement of Chinese drug inspector training system[J].Chin Pharm Aff(中国药事),2017,31(11):1276-1280.
[4]MA Y F,LIANG Y.Discussion on existing problems of GMP inspectors in drugs[J].J China Prescrip Drug(中国处方药),2010,8(4):68-69.
[5]YAN Z G,HAN F.Pharmaceutical inspector system and its enlightenment in Japan[J].J China National School Admin(国家行政学院学报),2018,(1):127-131,152.
[2]DENG T.Research on countermeasures of construction of the state professional inspector team of drug based on the successful experience of mayo clinic[J].China Licensed Pharm(中国执业药师),2016,(9):33-39.
[3]HUANG W H,TIAN S L,DONG J P,et al.Inspector training system and its enlightenment on the improvement of Chinese drug inspector training system[J].Chin Pharm Aff(中国药事),2017,31(11):1276-1280.
[4]MA Y F,LIANG Y.Discussion on existing problems of GMP inspectors in drugs[J].J China Prescrip Drug(中国处方药),2010,8(4):68-69.
[5]YAN Z G,HAN F.Pharmaceutical inspector system and its enlightenment in Japan[J].J China National School Admin(国家行政学院学报),2018,(1):127-131,152.