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张哲峰 | Zhang Zhefeng


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张哲峰

博士,北京培优创新医药生物科技有限公司科学总监、首席咨询师;培优药学苑药学部主任。中国医药教育协会药物创新与临床研究分会名誉主任委员;中国药学会抗生素专业委员会委员;科技部“新药创制重大专项”评委会成员;北京市及河北省科技成果评审专家;海南国际医药创新联合基金会名誉主任委员;国家“十三五”重点出版物《中华医学百科全书》编委;沈阳药科大学“药品注册与技术评价”专题学者;中国药科大学硕士生导师;北京理工大学硕士导师;《中国药学杂志》、《全球药讯》、《药物与临床》、《药品评价》等杂志编委。曾获全军科技进步二等奖和三等奖各一项。主编《新版药品注册管理办法解读》、《新版药品生产监督管理办法解读》。
在国家药品审评中心工作期间参与起草了《化学药物杂质研究技术指导原则》、《化学药品变更研究技术指导原则》、《合成多肽研究技术指导原则》、《化学仿制药CTD格式申报资料撰写要求》等9项技术指导原则和审评指南。
承担“科技部“新药创制重大专项”课题”-“药品注册标准数据库及应用查询系统建立”、“药品杂质数据库建立与应用”、“常用药用辅料数据库及应用查询系统”、“常用药用辅料数据库及应用查询系统”、“抗感染、抗肿瘤和心血管药物临床试验对照药品示范研究”等课题研究。


Zhang Zhefeng

Phd, scientific director and chief consultant of Beijing Peiyou innovation Pharmaceutical Biotechnology Co., Ltd; Director of Pharmacy Department of Peiyou pharmaceutical Academy. Honorary chairman of drug innovation and clinical research branch of China Medicine Education Association; Member of antibiotic Professional Committee of Chinese Pharmaceutical Association; Member of the jury of "major new drug creation project" of the Ministry of science and technology; The expert in the evaluation of scientific and technological achievements in Beijing and Hebei Province; Honorary chairman of Hainan International Union Foundation for Healthcare Innovation; Editorial board member of the national key publication "Encyclopedia of Chinese medicine" in the 13th five year plan; Professor of "drug registration and technology evaluation" of Shenyang Pharmaceutical University; Master supervisor of China Pharmaceutical University; Master supervisor of Beijing Institute of technology; Editorial board members of Chinese Journal of pharmacy, global pharmaceutical news, drugs and clinic, drug evaluation and other magazines.He won the second prize and the third prize of the army's scientific and technological progress. He edited the interpretation of the new measures for the administration of drug registration and the interpretation of the new measures for the supervision and administration of drug production.
During the work in Center for Drug Evaluation,NMPA, he participated in the drafting of 9 technical guiding principles and review guidelines, such as the technical guiding principles for the research of chemical drug impurities, the technical guiding principles for the research of chemical drug changes, the technical guiding principles for the research of synthetic peptides, and the requirements for the writing of CTD format declaration data of chemical generic drugs.
Undertake the "major special project for new drug creation" of the Ministry of science and technology - "establishment of drug registration standard database and application query system", "establishment and application of drug impurity database", "common pharmaceutical excipients database and application query system", "common pharmaceutical excipients database and application query system" "Demonstration study of controlled drugs in clinical trials of anti infective, anti-tumor and cardiovascular drugs".

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