Shuangmin Ji, PhD, Associate Director of Clinical Pharmacology and Modelling Simulation Department, GSK China. She graduated from School of Pharmacy, Peking University in 2016, then worked for Center for Drug Evaluation, National Medical Products Administration as a reviewer and associate professor from 2016 to 2022. She successively served as a reviewer in the Clinical Department of Biological Products and the Department of Statistics and Clinical Pharmacology, mainly engaged in the clinical evaluation of biological products in New Drug Applications, and technical review of clinical pharmacology-related contents. She led and finalized several guidance, e.g., Guidance of Population Pharmacokinetics, Guidance of Clinical Trials of Recombinant Human Coagulation Factor VIII.

博士，GSK中国临床药理及建模模拟部门副总监。2016年毕业于北京大学药学院，2016年至2022年期间就职于国家药品监督管理局药品审评中心任审评员、副研究员，先后在生物制品临床部、统计与临床药理学部担任审评员，分别主要从事药品注册申报中生物制品的临床评价工作、临床药理学相关内容的技术审评，并主笔起草完成了《群体药代动力学研究技术指导原则》、《重组人凝血因子Ⅷ临床试验技术指导原则》等多个技术指南。