基本信息
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个人简介
Twenty years of experience (eighteen years for Chinese Regulatory Authorities and two years of international experience at WHO headquarters) in Chemical Manufacture and Control (CMC) for biological products including biotherapeutics and vaccines, expertise in quality control and reference substances development at both national and international level; lead/coordinate the development of regulations, pharmacopeia and technical guidelines in the area of expertise for Chinese Regulatory Authorities as well as for WHO.
PROFESSIONAL TITLE AND QUALIFICATION
1) Senior Assessor, Office of Pharmaceutical Science of Biological Products, Centre for Drug Evaluation/ China Food and Drug Administration(CFDA);
2) Member of Expert Committee on Biopharmaceutical Standardization of Chinese Pharmacopoeia Commission;
3) GMP Inspector of Centre of Food and Drug Inspection, CFDA (overseas inspection qualified);
4) Member of National Drug Reference Standards Committee;
5) CFDA focal point with WHO and Coalition for Epidemic Preparedness Innovations(CEPI) Working Group on Norms and Standards;
6) Membership of WHO Expert Committee
− Expert Advisory Panel on International Pharmacopoeia and Pharmaceutical Preparations;
− Biologics Advisor of WHO International Nonproprietary Name for Pharmaceutical Substances (INN);
− Member of WHO Biosimilar Working Group;
7) Member of regulatory panel, American Society of Gene Therapy and Cell Therapy (ASGCT).
PROFESSIONAL TITLE AND QUALIFICATION
1) Senior Assessor, Office of Pharmaceutical Science of Biological Products, Centre for Drug Evaluation/ China Food and Drug Administration(CFDA);
2) Member of Expert Committee on Biopharmaceutical Standardization of Chinese Pharmacopoeia Commission;
3) GMP Inspector of Centre of Food and Drug Inspection, CFDA (overseas inspection qualified);
4) Member of National Drug Reference Standards Committee;
5) CFDA focal point with WHO and Coalition for Epidemic Preparedness Innovations(CEPI) Working Group on Norms and Standards;
6) Membership of WHO Expert Committee
− Expert Advisory Panel on International Pharmacopoeia and Pharmaceutical Preparations;
− Biologics Advisor of WHO International Nonproprietary Name for Pharmaceutical Substances (INN);
− Member of WHO Biosimilar Working Group;
7) Member of regulatory panel, American Society of Gene Therapy and Cell Therapy (ASGCT).
研究兴趣
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