2013年9月北京大学医学部整合公共卫生学院、药学院、北京大学第三医院，联手成立“北京大学医学部药品上市后安全性研究中心”。以《国家药品安全“十二五”规划》为指导方针，在国家药品监督管理局的领导下，中心先后承担国家药监局、北京市药监局的多项药品安全性研究课题，开展药品安全监管研究，对于药品安全监管的效果评价、指标设计以及执行改进、药物安全性研究等方面积累了丰富理论与实践经验，发表相关论文近百篇。     

研究领域：药品安全相关政策研究、循证宏观医疗卫生决策、药物流行病学、药事管理、药物安全性评价。

研究方向：1）提供政策咨询，向卫计委、药监局、发改委等中央与地方政府部门提供咨询；2）方法学研究，开展药物流行病学方法学研究，如数据库挖掘和安全信号的检出和分析等3）方法学指南， 开发药品上市后研究方法学指南，为国家制定相关政策提供依据；4）药品评价，创新药物、基本药物、中药注射剂、高风险药品的安全性评价：接受国家和企业的委托，开展相关评价。

   研究团队：1）詹思延教授团队在国内率先开展药物流行病学研究和教学，一直是国家药品安全监管部门的技术咨询机构，承担了大量药品上市后安全评价研究课题。2）史录文教授团队一直围绕药品政策与医药产业发展策略、医药卫生体制改革与医药事业发展策略、药事法规与监管技术、医院药事管理、药物经济学、药物信息体系等开展相关研究，极大促进了该行业的发展。3）翟所迪教授团队完成了数十项国内外包括生物药品、化学药品、中药一类新药一期的耐受性、药代动力学研究及生物等效性研究，成为国内一个重要的临床药理研究平台，为药物上市遴选和质量提高提供支撑。

   硬件设施：1）分子流行病学和药学实验室，能够广泛开展药物分子遗传流行病学实验，体内药物测定、小分子生物标识物和遗传药理学实验工作；2）拥有进行安全合理用药培训的模拟药房及药学信息中心，能够开展药品安全评价、数据挖掘工作。

    研究奖项：第十七届吴阶平-保罗？杨森医学药学奖、《2015全国药物流行病学学术年会暨学科发展20周年回顾》“中国药物流行病学学科开创工作者”、北京市科学技术奖三等奖、华夏医学科技奖二等奖、中华预防医学会科学技术三等奖、中国要学会科学技术三等奖。

詹思延教授主持国家级、省部级和国际合作课题数十项，以第一或责任作者发表SCI文章60余篇。主编出版了《临床流行病学》、《药物流行病学》等著作。任中国药学会流行病学专业委员会主任委员、药物流行病学杂志主编等。史录文教授以课题负责人身份承担了国家卫生和计划生育委员会、国家食品药品监督管理总局、美国中华医学基金会等科研机构资助的课题。以第一作者/责任作者SCI 论文40 余篇，获2012 年科学中国人年度人物等。翟所迪教授主持科技部863 计划、国家科技重大专项、卫生部国家临床重点专科建设项目等省部级以上课题10 余项，以第一或责任作者发表SCI文章40余篇。曾任中国医师协会循证医学专业委员会循证药学组等学术组织主委。

机构负责人：詹思延

联系人：孙凤

邮箱：sunfeng@hsc.pku.edu.cn

电话：010-82801191转1055

地址：北京市海淀区学院路38号北京大学公共卫生学院519室

网址链接：http://cpse.bjmu.edu.cn/

 

 

Center of Postmarketing Safety Evaluation PUHSC

In September 2013, Peking University of Health Science Center (PUHSC)has integrated the school of public health, the school of medicine and the Third Hospital of Peking University to jointly establish the " Center of Postmarketing Safety Evaluation (CPSE) PUHSC". Given the guidance of the 12th Five Year Plan for national drug safety and the leadership of the State Drug Administration, the center has successively finished a number of drug safety research projects of the National Medical Products Administration and Beijing Medical Products Administration, and accumulated large mounts of research experiences and abundant theoretical knowledges on the drug safety supervision, the effectiveness evaluation, index construction, quality improvement, etc, and has published nearly 100 related papers.

Research Fields: Pharmacoepidemiology, Evidence-based harmacy, Pharmaceutical policy study and Pharmacoeconomics.

 Research Scheme: 1) Provide consultations for central and local governments, including Ministry of Health, SFDA and NDRC; 2) Methodology Study: Carry out methodology researches of pharmacoepidemiology, for instance database mining, safety signals detection and analysis and so on; 3) Make methodology guideline of Post-Marketing Study to provide the basis for government’s policy-making; 4) Conduct safety evaluation of innovative drugs, essential drugs, Chinese medicine injections and high-risk drugs on commission of state and enterprise.

Research Team:1) Prof. Siyan Zhan has been a pioneer and initiated the research and teaching work of pharmacoepidemiology in China, has offered methodology consultation to National Medical Products Administration for drug safety surveillance, and has completed a large number of post marketing safety evaluation research for drugs. 2) Prof. Luwen Shi has dedicated to the research relating to the policy and development strategy of pharmaceutical industry, pharmaceutical regulations and regulatory technology, pharmaceutical management, pharmaceutical economics, pharmaceutical information system, etc. 3) Prof. Suodi Zhai has been in charge of dozens of phase I trials of demastic or abroad new drugs, including drug tolerance, pharmacokinetics and bioequivalence studies, which became one of critical clinical pharmacology research platform in China.

Research hardware: 1) the melecular epidemiology and pharmacology laboratories can undertake experiments of genetic and molecualr epidemiology of drug utility, determination of internal drug, small molecule biomarkers and pharmacogenetics experiments. 2) the simulation pharmacies and pharmaceutical information center can train for rational drug usage and do data mining for drug safety evaluation.

  Research Reward:  the 17th Wu Jieping Paul Yang Sen Medical Pharmacy award, "Chinese pioneer of pharmacoepidemiology" in 2015 National Academic Conference on pharmacoepidemiology and review of the 20th anniversary of discipline development, the third prize of Beijing Science and Technology Committee, the second prize of Huaxia Medical Science and Technology Committee, the third prize of science and technology award of China Preventive Medicine Association, and the third prize of Science and Technology Committee of China Key Society.

Professor Zhan Siyan presided over dozens of national, provincial and ministerial level and international cooperation projects, and published more than 60 SCI articles as the first or corresponding author, and has published the books of clinical epidemiology, pharmacoepidemiology, etc. She served as chairman of the epidemiology Committee of the Chinese Pharmaceutical Association and chief editor of the Chinese Journal of Pharmacoepidemiology.

Professor Shi Luwen undertaken the projects foundating by the National Health and Family Planning Commission, the National Food and Drug Administration, the Chinese Medical Foundation of the US, etc, and published more than 40 SCI papers as the first author or corresponding author, and also was awarded the Scientific Chinese Person of the 2012 year.

Professor Zhai Suodi presided over more than 10 provincial level projects, such as the 863 Program of the Ministry of Science and Technology, the Major National Science and Technology project, the National Key Clinical Specialty Construction project of the Ministry of Health, and published more than 40 SCI articles as the first or corresponding author, and used to be the chairman of evidence-based pharmacy group of evidence-based medicine professional committee of Chinese Medical Doctor Association.

 

Director: Siyan Zhan

Contact: Feng Sun

Email: sunfeng@hsc.pku.edu.cn

TEL: (+86)10-82801191-1055

Address: Room 519, School of Public Health Building Peking University Health Science Center, 38 Xue Yuan Road, Beijing, China.

Website：http://cpse.bjmu.edu.cn/