Our Team

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  Professor Doctoral Supervisor

  Graduated from West China Center of Medical Sciences, Shenyang Pharmaceutical University, Doctor of Science, Dr. Wu worked in CDE for 19 years, and engaged in the theoretical and practical research on drug registration management, technology evaluation, drug risk management and drug policy for 9 years. He successively served as secretary, chief pharmaceutical reviewer, director of General Office, director of Review Management And Coordination Department, deputy director of CDE (in charge of work), dean, professor and doctoral supervisor of school of business administration, Shenyang Pharmaceutical University.

   

  As the leading draftsman and participant, Dr. Wu participated in the construction of laws and regulations on national drug administration from 1990 to 2008. He led the change of national drug evaluation institution, established a series of regulations and technical specifications which are led by technical evaluation procedure, presided over the enaction and amendment more than 50 drug research technical guidelines, finished the evolution of drug technical evaluation from the secretary organization to technical institution.

  
  Dr. Wu is a national drug registration management and the main technical evaluation system builder. Guided by the handling of large security cases, he organized the reform of national drug evaluation (post-marketing assessment) and adverse drug reaction monitoring institutions, in the form of national project, preliminarily created the working mechanisms and information system of drug monitoring and warning on medical apparatus, establish a series of regulations and technical specifications which are led by the post-marketing re-assessment, laid a solid foundation for the development, is one of the main designers of the national drug post-marketing management and technical review system.

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  General Manager

  Graduated from Beijing Jiaotong University with a bachelor's degree and EMBA from the University of Hong Kong.

  
  He successively served as the director of the Review Management and Coordination Department of the CDE and the deputy minister of the Information Department, and the deputy general manager of Shijiazhuang No.4 Pharmaceutical Co., LTD. From 2000 to 2008, he worked in the drug registration administration department, participated in the drafting and revision of previous and existing regulations including current drug registration regulations, as well as the design of the drug review system and process. From 2008 to 2011, he worked in Shijiazhuang No.4 Pharmaceutical Co., LTD., a well-known large infusion enterprise in China ⸺where he accumulated rich practical experience in enterprise management.

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  Deputy General Manager

  Pharmaceutical chemistry research and pharmaceutical R&D at Institute of Materia Medica, Chinese Academy of Medical Sciences & Peking Union Medical College.

   

  A senior and proficient reviewer and administrator of CDE, worked successively as the Head of Pilot Work Team, Vice Minister of 5th Evaluation Dept., Deputy Head (Chairman) of 1st Chemical Drug Evaluation Dept., etc. of CDE, NMPA. Reviewed and approved nearly 40,000 applications of drug registration when working at CDE. Led to complete the drafting of more than 30 drug registration technology guidelines, technical standards and draft more than 10 guidelines and technical standards in person or as the technical leader. Led to readjust the concept of R&D and review of generic chemical drugs in China, plan and organize the implementation of ICH CTD format in China. Led to implement the adjustment of the evaluation strategy of chemical drugs, the changing the evaluation mode of chemical drugs innovation and the promotion of its technical requirements to be in line with international standards. Participated in the drafting, discussion and modification of pharmaceutical registration related regulations and laws after 2002.

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  Deputy General Manager

  Deputy General manager Xiaohong Zhang is in charge of Clinical Operation Department ; Master of Shenyang Pharmaceutical University;

   

  With strong project management skills, 20years' experience on clinical research;

   

  In charge of or involved in over 100 projects of new drug study in Chiatai Tianqing in oncology, endocrinology, and hepatinica, etc.
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  Deputy General Manager

  Deputy General manager Haiyan Huang is in charge of Business Development Department & Medical Affairs Department ; Master of China Pharma, Univ.;

   

  
  Studied the related courses of Translational Medicine in the School of Medicine of Tsinghua University.

   

  Used to be the Deputy GM of Nanjing Changao, mainly in charge of clinical research and regulatory affiars.

   

  With more than 20 years of working experience,  presided over or participated in dozens of Phase I to Phase III clinical research projects , involving digestive and infectious areas,  innovative drugs and imported drugs. In addition, she also participated in the more than 30 BE projects.