基于药品研发周期构建多向风险管理机制  

Constructing pharmaceutical R&D cycle-based multi-directional risk management mechanism

作　　者：李章明[1] 朱文良[2] 刘兰茹[1] 朱虹[1] 

机构地区：[1]哈尔滨医科大学人文社会科学学院药事管理教研室,哈尔滨150081 [2]哈尔滨医科大学附属第二医院药学部,哈尔滨150001

出　　处：《中国新药杂志》2015年第7期737-740,共4页Chinese Journal of New Drugs

基　　金：黑龙江省教育厅2013年度人文社会科学面上项目(12532215)

摘　　要：通过分析药品研发周期风险因素,利用文献资料采取综述的方法,构建药品研发多向风险管理机制,从而提高新药研发的成功率,最大程度地降低医药企业承担的研发风险,使新药研发周期达到良性循环,将合作是多赢的风险管理战略理念应用于药品研发周期中,以增强药品研发管理机制的科学性与张力,进一步改善药品研发风险管理,保障公众用药安全。By analyzing the risk factors for pharmaceutical R＆D cycle and summarizing the literature data, we constructed the mechanism of multi-directional risk management in order to improve the success rate of drug R＆D, minimize pharmaceutical R＆D risk for pharmaceutical companies, and achieve a virtuous cycle. The con- cept that cooperation is a win-win situation should he taken as a risk management strategy in pharmaceutical R＆D cycle in order to enhance the scientificity and tension of pharmaceutical R＆D management mechanism, further im- prove pharmaceutical R＆D risk management and ensure the safety of the public drug use.

关 键 词：药品研发 研发周期 风险管理 合作 机制 

分 类 号：R95[医药卫生—药学]