谢沐风,上海市食品药品检验所

1990年 ~ 1995年 沈阳药科大学 日语药学专业 本科毕业

1995年 ~ 1998年 沈阳药科大学 药物分析专业 硕士研究生毕业

1998年~至今 上海市食品药品检验所 化学室工作

从事化学药品新药复核、方法学研究、药典起草、质量标准制订等工作。

2003年8月 ~ 2004年2月

赴日本国立医药品食品卫生研究所(为该国国家药品检验所)药品部进修。

详细了解了发达国家对于药品的审评要点与技术要求;深入学习了“日本药品品质再评价工程”实施与技术应用，掌握了“如何采用溶出度技术评价固体制剂内在品质”方法与手段，深谙了发达国家提高和控制药品内在品质的具体措施与手段。

2008年11月 ~ 2009年1月

借调至国家药品检验所(即中检所)起草2010年版药典《溶出度试验指导原则》。

Ø 截止目前，发表了多篇方法类、思路类文章;尤多篇溶出度专著引起业内关注。

Ø 2004年起、担任《中国医药工业杂志》特约编委。

Ø 2006年起~至今 担任国家药品监督局培训中心“化学药质量方面”授课教师。着重讲述仿制药质量评价、溶出度检测技术在固体制剂内在质量评价中的作用、有关物质的研究与制御、工艺放大与评价等内容。

Ø 2007年起、在全国范围内(科研院所、大专院校、生产企业等)作了近50多场“药品高科技的体现——溶出度专题讲座”和“如何依靠技术从众多药企中脱颖而出”主题演讲，引起业内人士广泛共鸣。

Ø 2009年1月、在国内最为知名的药学网站——丁香园“药物分析版”创立“溶出度研究”子版，截止目前，该内容已成为国内研发人员的必读手册。

Ø 2009年5月起~至今 任国家食品药品监督管理局市场监督办公室专家顾问 负责指导度“全国评价性抽验工作”，并首次全面引入“如何利用体外溶出曲线评价固体制剂内在品质差距”理念，收到显著效果。

Ø 2010年起 担任国家药监局新药审评中心顾问，主持编译了《日本橙皮书》和《日本仿制药生物等效性试验系列指导原则》等。

Ø 2010年起 担任《药品评价杂志(医院版)》编委。

Ø 2012年3月 已参与到《中国药品品质再评价工程》小组启动工作中……

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——www.dxy.cn; 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 …