A公司药品CMO技术转移中进度管理和风险管理

发布时间：2019-02-24 12:12

【摘要】：近年来,全球大多数制药企业都面临着专利药物到期、新药研发难度增加、成功率低、进度缓慢等问题,世界制药业巨头大多采取技术转移的方式来降低成本维持利润率。这些专利药物大多在欧美日等发达国家进行生产,将这些产品的生产转移到成本较低的发展中国家,提高净利润。中国由于具有制药规模大、成本较低以及巨大的医药市场潜力等优势,正成为制药巨头们进行技术转移的乐土。世界卫生组织(WHO)、国际制药工程协会(ISPE)等也为此出版了关于药品技术转移的指南,目前国内还没有一套成熟完整的关于药品技术转移的指南文件和实践指导。本文通过分析国内外技术转移状况差异,应用项目管理中的进度管理和风险管理工具对技术转移进行过程管理,并结合大型跨国制药企业在药品技术转移方面的实际经验,建立科学的药品技术转移模型,识别药品技术转移过程中的风险点,并制定相应的降低风险措施,确保项目的顺利进行并通过市场GMP认证和市场准入,确保企业能够科学的控制成本,并保证产品的质量稳定性。通过本文研究,希望提出的药品技术转移模型能够为我国制药企业实施产品转移项目所用,并帮助更多的中国制药企业适应市场需求,走向国际市场。
[Abstract]:In recent years, most pharmaceutical enterprises in the world are facing the problems of patent drug expiration, increasing difficulty of new drug research and development, low success rate, slow progress and so on. Most of the world pharmaceutical giants adopt technology transfer to reduce the cost and maintain profit margin. Most of these patented drugs are produced in developed countries such as Europe, America and Japan, shifting their production to lower-cost developing countries and increasing net profits. Because of the advantages of large scale, low cost and huge potential of pharmaceutical market, China is becoming a good place for pharmaceutical giants to transfer technology. The World Health Organization (WHO),) International Pharmaceutical Engineering Association (ISPE) has also published a guide on drug technology transfer. At present, there is not a complete set of guidelines and practical guidance on drug technology transfer in China. Based on the analysis of the differences of technology transfer situation at home and abroad, this paper applies the project management and risk management tools to the process management of technology transfer, and combines the practical experience of large multinational pharmaceutical enterprises in drug technology transfer. Establish a scientific model of drug technology transfer, identify the risk points in the process of drug technology transfer, and formulate corresponding risk reduction measures to ensure the smooth progress of the project and pass the market GMP certification and market access. Ensure that the enterprise can control the cost scientifically and ensure the quality stability of the product. Through the research of this paper, it is hoped that the proposed drug technology transfer model can be used by Chinese pharmaceutical enterprises to implement product transfer projects, and help more Chinese pharmaceutical enterprises to adapt to the market demand and to move to the international market.
【学位授予单位】：华东理工大学
【学位级别】：硕士
【学位授予年份】：2015
【分类号】：F426.72;F273

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