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北京大学英语新闻网/Peking University News
New area of cooperation started
between PKU and FDA
PKU NEWS 2007--06--06
http://ennews.pku.edu.cn/news.php?s=181134607
Peking University, Beijing, June 6th, 2007: On the afternoon of June 1, the
commencement ceremony for PKU international medicine ME programme was
formally opened in the main hall of Linhu Xuan, together with the high-level dialogue
and a media meeting between the United States Food and Drug Administration
(FDA) and enterprises.
This meeting was hosted by Dr. Zheng Qiang, director of Center for Pharmaceutical
and Engineering Research as well as prof. of College of Engineering. Dr. Moheb
Nasr, director of FDA Office of New Drug Quality Accreditation and Mr. Joseph
Famulare, vice director of FDA Enforcement Office attended it, discussion of this
meeting focusing on the theme of ‗Quality by Design‘.
In fact, almost 3 years have passed since PKU and FDA first worked together. In
December 2005, a FDA cGMP training programme was held jointly by PKU, FDA
and the International Drug Association (ISPE) while in April 2006, the FDA cGMP
China Forum was held at PKU. These two activities attracted more than 500
participants from more than 200 enterprises and Drug Administration Bureaus of not
only China, but also some neighboring countries. However, to improve the quality
management system of Chinese pharmaceutical industry and its supervision
management fundamentally, three main parties of these two activities realized that
these short-term training alone was far from enough. And it was FDA that first
proposed this international medicine ME programme should be set up at PKU.
The curriculum of PKU international medicine ME programme, designed under the
guidance of Mr. Joseph Famulare, vice director of FDA enforcement office, is the
embodiment of contemporary concepts and authoritative views on the international
pharmaceutical engineering management. In this programme, FDA officials will
personally give students lectures on quality management system and FDA
regulations. At the same time, China's relevant government authorities and experts
will participate in lectures and seminars as well. It is without doubt that this ME
programme stands for a new area of cooperation between PKU and FDA.
Edited By : Liu Qin
Translated By : Li Shuang
Source : PKU news (Chinese)
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