新药合同研发（CRO）中的GMP风险管理

发布时间：2017-12-27 10:40

本文关键词：新药合同研发（CRO）中的GMP风险管理　出处：《华东理工大学》2015年硕士论文　论文类型：学位论文

【摘要】：制药业具有重要的经济和社会价值。作为制药业健康发展的推动力,新药研发决定了行业的未来,但其周期长、投入大、风险高的特点一直是业内外人士津津乐道的话题。新药研发的风险具体包括财务风险、技术风险、管理风险、生产风险、市场风险和环境风险。作为最重要的发展中国家和最大的新兴医药市场,中国也将制药业放在一个举足轻重的地位,并对新药研发提供了各种扶持政策。我国的新药研发水平在资金、制度、人才、管理等各方面都落后于欧美日等发达国家,尤其是项目管理能力欠缺,造成了资源浪费、人才流失、进度拖沓等一系列严重后果。作为制药行业的一个新兴领域,合同研究组织(CRO)从欧美兴起,并进入中国,成为国内制药公司新药研发方面的重要支持。企业与CRO之间如何相互协作,从而降低项目风险,成为新药研发参与者需要面临的新课题。药品的质量是设计、生产和检验的过程,质量源于设计也是业内的共识,因此在研发过程中要始终融入GMP精神。本文分析了制药企业在新药研发过程中面临的各种风险,以及如何利用CRO的优势规避或降低研发风险,并通过实际案例具体说明在各个阶段需要重点关注的研发风险以及如何应对。该项目在当今行业中属于典型案例,取得了阶段性成果,为其他类似项目提供借鉴作用。
[Abstract]:The pharmaceutical industry has an important economic and social value. As the driving force for the healthy development of the pharmaceutical industry, the development of new drugs determines the future of the industry, but its long cycle, large investment and high risk are always the topic of interest both inside and outside the industry. The risks of new drug development include financial risk, technical risk, management risk, production risk, market risk and environmental risk. As the most important developing country and the largest emerging pharmaceutical market, China has also placed the pharmaceutical industry in a pivotal position, and has provided various supporting policies for the development of new drugs. The level of new drug development in China is lagging behind the developed countries such as Europe, America and Japan in terms of capital, system, talent and management. Especially the lack of project management has resulted in a series of serious consequences, such as waste of resources, brain drain and slow progress. As a new field of pharmaceutical industry, contract research organization (CRO) has emerged from Europe and America, and has entered China. It has become an important support for new drug development in domestic pharmaceutical companies. How enterprises and CRO cooperate with each other to reduce project risk has become a new topic for new drug R & D participants. The quality of drugs is the process of design, production and inspection. The quality of the drug is also the common understanding in the industry. Therefore, the spirit of GMP should always be integrated in the process of R & D. This paper analyzes the risks faced by pharmaceutical companies in the process of new drug development, and how to take advantage of CRO to avoid or reduce R & D risks, and illustrates the risk of R & D at various stages and how to deal with them. The project is a typical case in today's industry, and has achieved some stage results and provides a reference for other similar projects.
【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】：F407.72;F273.1

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