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Research Center for Pharmaceutical Information and Engineering

Mission

To elevate the science-based approach to pharmaceutical quality regulation, R&D and manufacturing by means of education and applied research

 

Vision

A pioneer in applied research and education in pharmaceutical quality management and a proponent for modernization of China’s pharmaceutical regulation and industry

A dialog platform of global partnerships in academia, government and industry

A catalyst in attracting sponsors to support applied research of practical value

An info resource base for the global community and regional development in China

 

Initiatives

Integrating education, research and dialog activities for government, industry and academia, domestic and abroad, to identify research topics, collaborators and customers

Established a master’s degree program in international pharmaceutical engineering management (IPEM) to provide leadership training to government and industry

Established an international dialog platform for government, industry and academia to promote the international quality standard and good practices

Initiated a comprehensive mathematical modelling and database research program to quantitatively characterize the quality risks of drug manufacturers and suppliers 

 

Accomplishments

CIPER has demonstrated the value of its mission, the achievability of its vision, the timeliness of its initiatives and the sustainability of its operation

Built China’s first program for teaching the international quality standard and good practices, with a curriculum co-designed by US FDA and a world class faculty team

Organized 30 international workshops and meetings on topics ranging from drug quality and safety and efficacy to government policy and legal framework

Provided China’s regulatory agencies with original research reports on regulatory systems for pharmaceutical quality, safety and efficacy

Developed China’s first quantitative quality risk model for drug manufacturers, which includes a database with built-in alerts, decision support and display tools

 

About CPIER

Established in 2006, CPIER has ten full-time staff members. Its director, Dr. Qiang Zheng, is on faculty in the Department of Industrial Engineering and Management in the College of Engineering and has 20 years of experience in mathematical modelling, drug R&D, software development, and quality management systems

Major funding sources for CPIER are the tuition income of the IPEM program and the Peking University Education Fund

Major partners include SFDA, US FDA, Beijing and Shanghai FDAs, Hisun, CSPC, Anbison Lab, Merck, Pfizer, Amgen, Lilly, Gilead, J&J, Agilent, RDPAC and ISPE