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论文编号：	15173
作者编号：	2320224043
上传时间：	2024/12/11 13:45:20
中文题目：	Z公司原料药国际注册项目风险管理研究
英文题目：	Research on Risk Management on API International Registration of Z Company
指导老师：	程莉莉
中文关键字：	原料药；国际注册；风险管理；风险识别；风险评估
英文关键字：	APIs, International Registration, Risk Management, Risk Identification, Risk Assessment
中文摘要：	当前，中国已成为全球原料药生产和出口领域的领头羊。面对国际市场需求的持续膨胀，国内原料药企正积极拓展海外市场，原料药国际注册的竞争亦随之日趋激烈，这一现状对国内企业而言，既是机遇更是挑战。与其他行业相比，制药领域因其产品的特殊性，在市场准入和行业监管上存在更多独特性，导致企业承受的风险水平更高。2005年，国际注册协调会议（ICH）将风险管理纳入药品GMP管理体系，发布了《Q9质量风险管理》指南，为药品全生命周期中的风险识别、评估及控制提供了系统性指导。查阅文献显示，关于药品国际注册的研究，多数集中于对比中国药政法规及GMP现状与海外法规的异同，然而，针对风险管理进行深度探讨并将项目风险管理理论实际应用于原料药国际注册项目的研究则甚少。随着原料药国际注册项目的不断增多，对该领域项目风险管理的深入研究需求日益迫切。 本文在综合分析项目风险管理相关理论知识的基础上，以Z公司原料药的国际注册项目为研究对象，对原料药国际注册项目的风险管理进行了分析和探索。首先对Z公司原料药的国际注册情况进行了简单介绍，根据作者的工作经验，对原料药国际注册项目中的风险进行识别，并通过对调查问卷的数据分析得到了原料药国际注册项目各风险因素的风险水平，进而利用层次分析法对原料药国际注册项目进行评价，进而推算出该项目的风险水平。最后从预防风险、规避风险、转移风险、减轻风险、接受风险等风险管理应对策略对部分风险因素进行了分析。 本文的研究结果证明，在Z公司原料药国际注册项目管理中的风险识别和管理分析的方案，可以提高原料药国际注册项目风险管理的质量，有效的把控项目的进度。同时，针对Z公司原料药国际注册项目管理中的风险识别与管理分析改进，具有很强的现实意义和指导作用，对于Z公司其他项目以及其他公司的项目的风险管理提升也有借鉴的意义。
英文摘要：	At present, China has become the world's most important API producer and exporter, the growing international demand will drive China's API companies to further develop the international market, and the international registration competition of APIs is also intensifying, which is both an opportunity but also a challenge for domestic API companies. Compared with other industries, as a special type of commodity, pharmaceutical companies face higher risks due to the particularity of drug market access and pharmaceutical industry management. In 2005, ICH formally incorporated risk management into the drug GMP regulatory system, and promulgated the "Q9 Quality Risk Management", which provides guidelines for the identification, evaluation and control of risks throughout the drug life cycle. A review of the literature found that the most research on the international registration of drugs in China is to compare the current status of China's pharmaceutical regulations and GMP supervision with those in foreign markets, but there are very few studies on risk management and the application of project risk management theory to the international registration of APIs. With the increasing number of international API registration projects, the demand for risk management research on API international registration projects is also increasing. Based on the comprehensive analysis of the theoretical knowledge related to project risk management, this thesis analyzes and explores the risk management of the international registration of API in Company Z with the international registration of API as the research object. Firstly, the international registration of API in Company Z was briefly introduced, and the risks of the international registration project of API were identified according to the author's work experience, and the risk level of each risk factor of the international registration project of API was obtained through the data analysis of the questionnaire, and then the international registration project of API was evaluated by analytic hierarchy process, and then the risk level of the project was calculated. Finally, some risk factors are analyzed from the risk management response strategies such as risk prevention, risk avoidance, risk transfer, risk mitigation, and risk acceptance. The results of this thesis prove that the risk identification and management analysis scheme in the management of the international registration project of company Z can improve the quality of risk management of the international registration project of the API and effectively control the progress and cost of the project. At the same time, the improvement of risk identification and management analysis in the management of the international registration project of Company Z's API has strong practical significance and guiding effect, and also has reference significance for the improvement of risk management of other projects of Company Z and other companies' projects.
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