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作者: 文章来源:  点击数:10991  发布时间:2012-05-16

Xie Mufeng, Shanghai Institute for Food and Drug Control

1990 ~ 1995 Shenyang Pharmaceutical University, majored in Japanese Pharmaceutical Science, Bachelor’s Degree

1995 ~ 1998 Shenyang Pharmaceutical University, majored in Pharmaceutical Analysis, Master’s Degree

1998~Now Working in the Chemical Department of Shanghai Institute for Food and Drug Control,

Responsible for reviewing new chemical drugs, conducting methodology research, drafting pharmacopeia and developing quality standard etc

August, 2003 ~ February, 2004

Engaged in advanced studies in the Pharmaceutical Department of Japanese National Institute of Health Sciences (Japanese National Institute for Drug Control);

Understood in details the key points of drug examination and evaluation and technical requirements in developed countries, conducted in-depth study of implementation and technical application of Japanese Drug Quality Re-evaluation Project, mastered the methods and means for using dissolution rate technique to evaluate intrinsic quality of solid preparations, and gained an intimate understanding of specific measures and means for improving and controlling intrinsic quality of drugs in developed countries.

November, 2008 ~ January, 2009

Temporarily transferred to National Institute for Food and Drug Control to draft 2010 Version Pharmacopeia the Guiding Principles for Dissolution Rate Testing

Ø Until now,published many articles concerning methodology and thinking, especially many monographs focusing on dissolution rate which have attracted wide attention in the industry

Ø Since 2004 Serving as special editorial board member of Chinese Journal of Pharmaceuticals

Ø 2006~Now Teacher of Training Center of State Food and Drug Administration, teaching the quality of chemical drugs; focusing on quality evaluation of generic drugs, the roles of dissolution rate testing technique in evaluating intrinsic quality of solid preparations, research and control of relevant substances, process scale-up and evaluation etc.

Ø Since 2007 Gave more than 50 special lectures on “Embodiment of High Pharmaceutical Technology - Dissolution Rate” and keynote speeches on “How to Outperform Among Numerous Pharmaceutical Enterprises by Relying on Technology” nationwide (research institutes, institutions of higher learning, manufacturers), arousing wide attention from industrial insiders.

Ø January, 2009 Created the Dissolution Rate Research column on the Pharmaceutical Analysis webpage of domestic most famous pharmaceutical website——; so far, such content has become essential manual for domestic research and development personnel.

Ø May, 2009~Now Serving as Expert Advisor of Market Supervision Office of State Food and Drug Administration, responsible for guiding on national evaluation and sampling inspection and fully introducing the philosophy of Applying In Vitro Dissolution Curve to Evaluate Intrinsic Quality Gap of Solid Preparations for the first time, producing significant effect.

Ø Since 2010 Advisor of National Center for Drug Evaluation, directing compilation of Japanese Orange Book and Japanese Series Guiding Principles for Bioequivalence Test of Generic Drugs etc

Ø Since 2010 Editorial board member of Journal of Drug Evaluation (Hospital Version)

Ø March, 2012 Participated in launching the Team of China Drug Quality Re-evaluation Project …

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