本文關(guān)鍵詞： 全過程 疫苗安全 影響因素 監(jiān)管對策　出處：《南京中醫(yī)藥大學(xué)》2013年碩士論文　論文類型：學(xué)位論文

【摘要】：近年來,生物醫(yī)藥產(chǎn)業(yè)發(fā)展迅速,從其發(fā)展趨勢來看,產(chǎn)業(yè)化進程明顯加快。我國的生物制品產(chǎn)業(yè)發(fā)展同樣快速,尤其是疫苗產(chǎn)業(yè)發(fā)展,取得了令人矚目的成績。但隨著一系列有關(guān)疫苗安全的事件相繼曝出,疫苗安全被推到輿論的風(fēng)口浪尖,表明疫苗在研制、審批、生產(chǎn)、流通、使用、上市后不良反應(yīng)監(jiān)測等環(huán)節(jié)存在著突出問題,反映出當(dāng)前疫苗市場混亂局面,同時也反映出疫苗監(jiān)管工作存在著某些方面的漏洞。如監(jiān)管部門職能定位不準確、人員專業(yè)性不夠、監(jiān)管制度設(shè)計不合理等因素,可以以此為契機探討引發(fā)導(dǎo)致疫苗不安全現(xiàn)象的一些關(guān)鍵原因。 文章以全過程視角中各環(huán)節(jié)疫苗安全影響因素為研究對象,通過文獻法、專家咨詢法、問卷調(diào)查法以及數(shù)據(jù)分析方法對疫苗安全影響因素進行收集、篩選、統(tǒng)計、分析,還將國內(nèi)外疫苗安全監(jiān)管的特點進行了比較,得出我國疫苗安全影響因素主要為人員和制度因素。本文研究視角以及研究方法具有一定創(chuàng)新性,從全過程視角出發(fā),用實證研究的方法對疫苗安全影響因素進行分析,但由于樣本數(shù)量的局限以及評價者因素,本研究尚有不足之處需要彌補。
[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.
【學(xué)位授予單位】：南京中醫(yī)藥大學(xué)
【學(xué)位級別】：碩士
【學(xué)位授予年份】：2013
【分類號】：F203;F426.72

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本文編號：1442906