“Dushu Lake Prize”Selection of China Pharmaceutical Innovation Brand“Dushu Lake Prize”Selection of China Pharmaceutical Innovation Brand

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Li Kexin

Director of Beijing Hospital Clinical Trial Research Center (BJH-CTC) 


Prof, Head of Beijing Hospital Clinical Trial Center. National New Drug Review Expert, National Inspector of GCP and GLP, Reviewer of China National Accreditation Service(CNAS)for Conformity Assessment.

2011-2013,working in Center for food and drug inspection of CFDA, Key responsible for supervision Phase 1 trial and other relevant task, leading drafter of Chinese“Phase 1 trial laboratory accreditation criteria”,“ Bio-analytical laboratory accreditation criteria”, and “Inspection criteria of phase1 clinical trial program”, organizing and conducting pilot inspection to first Phase 1 trial laboratory and bio-analytical laboratory nationwide, 2013 national special inspection of bioequivalence studies etc. Member of core expert panel of National clinical study data inspection, participated in inspector training, on-site inspection and reviewing of inspection results.

2006-2008, Visiting scholar, Vanderbilt Center for Neuroscience Drug Discovery Vanderbilt University Medical Center, USA

2000-2001, working in Center for Drug Evaluation, CFDA.

Participated in compilation of“Technical guidelines for studies using pharmacokinetic parameter as endpoint to evaluate bioequivalence of chemical generic drugs”,“ Technical guidelines for chemical bioavailability and bioequivalence studies” ,“Technical guidelines for Clinical pharmacokinetics technics”, “Technical guidelines forestimating themaximumsafe startingdose inadulthealthy volunteers” ,“Technical guidelines fornon-clinical pharmacokinetics technics” “Policies regarding TQT trials”, and establishment of other Chinese technical guidelines.

As PI, in charge of about a hundred phase 1 trials including Fist in human trial, pharmacokinetics studies, bioequivalence trials etc. and experienced in risk management of new drug development.



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