新药研发外包中的风险控制  

Risk control of the new drug R&D outsourcing

作　　者：佟笑[1] 陈玉文[1] 

机构地区：[1]沈阳药科大学工商管理学院,辽宁沈阳110016

出　　处：《沈阳药科大学学报》2015年第11期887-891,共5页Journal of Shenyang Pharmaceutical University

基　　金：科技部"十二五"重大新药创制国家科技重大专项"辽宁省国家重大新药创制综合平台―基于信息管理的新药研发风险控制技术"(2013ZX09301305)

摘　　要：目的探讨如何控制新药研发外包中可能出现的风险。方法主要分析了新药研发外包各阶段可能存在主要的风险及危害。结果与结论有针对性地采取风险控制措施:如建立科学的外包服务商选择评估体系;制定严谨、灵活的合作合同;建立利益共享、风险共担机制;建立有效的信息反馈、绩效测评机制等。都将有效实现对研发外包潜在风险的控制,使企业研发外包收益最大化。Objective To discuss howto control the potential risks in the RD outsourcing of the newdrugs.Methods Potential risks and its danger in the RD outsourcing of the newdrugs in different phase were analyzed. Results and Conclusion The risk control methods should be put into use targetedly,such as bringing in outsourcing service providers＇ competitive mechanism,enacting flexible cooperating compact,establishing benefit and risk sharing mechanism,setting up effective information feedback and performance evaluation mechanism and so on. All these methods can control the potential risks in the RD outsourcing effectively,and maximize the profits of the enterprises＇ RD outsourcing.

关 键 词：风险管理 研发外包 运用 探讨 

分 类 号：R951[医药卫生—药学]