特聘教授 国家药品监督管理局药品评价中心（CDE，NMPA）药物化学与临床评价专家 Visiting Professor of Practice Pharmaceutical CMC Evaluation Expert, National Medical Products Administration Center for Drug Evaluation (CDE, NMPA)
Dr. Zhang Xingyi is a pharmaceutical scientist with 20 years of experience in drug research and development/CMC technology evaluation and regulatory science. He is familiar with drug regulatory policies and technical requirements in China, the European Union/United States, and Japan.
Dr. Zhang is an EWG expert in the ICH Quality Control Working Group and the head of the ICH Q1 Stability Group.
He is the scientific leader of NMPA CDE in the evaluation of complex generic drugs such as local, ophthalmic, nasal drugs, and devices. He was selected for the official study abroad program at Kyoto University in Japan organized by the Sasagawa Foundation and the Ministry of Health of the People’s Republic of China, and is proficient in conducting academic exchanges in fluent English and Japanese.
He has conducted pharmacokinetic research at the Pharmacy Department of Peking University and pursued further studies in the Economics Department of Guanghua School of Management at Peking University, enabling him to track and analyze the profound impact of constantly changing regulatory changes and economic situations on the pharmaceutical industry not only from the perspective of pharmaceutical science, but also from the perspectives of finance and economics. He has published over 20 academic research papers and patents in the fields of drug technology review, digital modeling, and economic research, possessing extensive knowledge in various fields ranging from pharmaceutical investment to artificial intelligence.
张星一博士
特聘教授
国家药品监督管理局药品评价中心（CDE，NMPA）药物化学与临床评价专家
Visiting Professor of Practice
Pharmaceutical CMC Evaluation Expert, National Medical Products Administration Center for Drug Evaluation (CDE, NMPA)
Dr. Zhang Xingyi is a pharmaceutical scientist with 20 years of experience in drug research and development/CMC technology evaluation and regulatory science. He is familiar with drug regulatory policies and technical requirements in China, the European Union/United States, and Japan.
Dr. Zhang is an EWG expert in the ICH Quality Control Working Group and the head of the ICH Q1 Stability Group.
He is the scientific leader of NMPA CDE in the evaluation of complex generic drugs such as local, ophthalmic, nasal drugs, and devices. He was selected for the official study abroad program at Kyoto University in Japan organized by the Sasagawa Foundation and the Ministry of Health of the People’s Republic of China, and is proficient in conducting academic exchanges in fluent English and Japanese.
He has conducted pharmacokinetic research at the Pharmacy Department of Peking University and pursued further studies in the Economics Department of Guanghua School of Management at Peking University, enabling him to track and analyze the profound impact of constantly changing regulatory changes and economic situations on the pharmaceutical industry not only from the perspective of pharmaceutical science, but also from the perspectives of finance and economics. He has published over 20 academic research papers and patents in the fields of drug technology review, digital modeling, and economic research, possessing extensive knowledge in various fields ranging from pharmaceutical investment to artificial intelligence.