全过程视角的疫苗安全影响因素分析

发布时间：2018-01-19 06:01

本文关键词： 全过程疫苗安全影响因素监管对策　出处：《南京中医药大学》2013年硕士论文　论文类型：学位论文

【摘要】：近年来,生物医药产业发展迅速,从其发展趋势来看,产业化进程明显加快。我国的生物制品产业发展同样快速,尤其是疫苗产业发展,取得了令人瞩目的成绩。但随着一系列有关疫苗安全的事件相继曝出,疫苗安全被推到舆论的风口浪尖,表明疫苗在研制、审批、生产、流通、使用、上市后不良反应监测等环节存在着突出问题,反映出当前疫苗市场混乱局面,同时也反映出疫苗监管工作存在着某些方面的漏洞。如监管部门职能定位不准确、人员专业性不够、监管制度设计不合理等因素,可以以此为契机探讨引发导致疫苗不安全现象的一些关键原因。文章以全过程视角中各环节疫苗安全影响因素为研究对象,通过文献法、专家咨询法、问卷调查法以及数据分析方法对疫苗安全影响因素进行收集、筛选、统计、分析,还将国内外疫苗安全监管的特点进行了比较,得出我国疫苗安全影响因素主要为人员和制度因素。本文研究视角以及研究方法具有一定创新性,从全过程视角出发,用实证研究的方法对疫苗安全影响因素进行分析,但由于样本数量的局限以及评价者因素,本研究尚有不足之处需要弥补。
[Abstract]:In recent years, the biopharmaceutical industry has developed rapidly, from its development trend, the industrialization process has been accelerated obviously. The biological products industry in China has also developed rapidly, especially the vaccine industry. Remarkable achievements have been made, but with the revelation of a series of incidents concerning vaccine safety, vaccine safety has been pushed to the forefront of public opinion, indicating that vaccines are being developed, approved, produced, circulated and used. There are outstanding problems in the monitoring of adverse reactions after listing, which reflects the current chaotic situation in the vaccine market, and also reflects the loopholes in some aspects of vaccine supervision, such as the inaccurate functional positioning of the regulatory authorities. Some factors, such as lack of professional personnel and unreasonable design of supervision system, can be used as an opportunity to explore some key reasons that lead to the unsafe phenomenon of vaccine. This article takes the whole process perspective of vaccine safety factors as the research object, through the literature method, expert consultation method, questionnaire survey and data analysis methods to collect and screen the vaccine safety factors. Statistics, analysis, and comparison of the characteristics of domestic and foreign vaccine safety supervision, the main factors affecting vaccine safety in China are personnel and institutional factors. This research perspective and research methods are innovative. From the point of view of the whole process, the factors affecting vaccine safety are analyzed by the method of empirical research. However, due to the limitation of sample size and the factors of evaluator, there are still some deficiencies in this study.
【学位授予单位】：南京中医药大学
【学位级别】：硕士
【学位授予年份】：2013
【分类号】：F203;F426.72

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