主講人：Linda (Ruimei) Li

時間：2018年12月17日 9:30

地點：科研樓五層報告廳

報告題目：Clinical Trial Program Management: Dos & Don'ts

主講人簡介：

Linda (Ruimei) Li, M.D., Ph.D., GCP, CCRA CEO of GCP Clinica Service.

Dr. Li obtained M.D. in Epidemiology and M.Sc. in Public Health from Shandong Medical University, Ph.D. in Pathology from National University of Singapore, completed postdoctoral fellowship at NIH, USA.

Dr. Li is a seasoned medical professional with 20+ years of experience and increasing responsibility and leadership roles at investigator site (MD Anderson Cancer Center), CRO industry (ICON PLC), large pharmaceutical company(Gilead), and small biotech companies(NANTKWEST, ASTEX Pharma, etc.), US government (NIH) and CDC subsidiary in China. Thorough knowledge and understanding of FDA and EMEA, PMDA, and CFDA Regulations, ICH Guidelines, and GCPs/GVPs governing the conduct of clinical trials. Lead over 40 global clinical trials with focuses on oncology, virology and inflammation. Contributed to 10 new drug/vaccine approvals in USA, EU, China, and NDA filing of Epclusa for HCV in Japan, etc. Developed global clinical programs in combination therapy of multiple investigational products from proof of concept to late stage development. Supervised all levels of clinical study teams. Proven capability to evaluate and translate complex scientific/clinical data, identify safety and efficacy signals, prepare and review all regulatory and clinical documents. Built up and maintained active connections with over 600 principal investigators (oncologists, rheumatologist and nephrologists) in North America and Asia, and over 300 HIV principal investigators globally.

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