杨焕 研究员

  • 国家食品药品监督管理局


机构:国家食品药品监督管理局

职称:医学博士

职务:临床医学研究员

简介:

自2002年以来在国家食品药品监督管理总局(CFDA)的药品审评中心(CDE)进行化学药品和生物制品的临床专业审评工作。目前是生物制品临床部的高级审评员和临床专业主审人,从事疫苗、血液疾病、基因和细胞治疗等新药临床专业技术审评。还参加CFDA/CDE的多项与药物注册审评审批相关的政策法规、临床指导原则制定及国家课题研究。同时承担十一届药典委员会委员、第一届国家免疫规划专家咨询委员会成员,及《中国新药杂志》编委等工作。


Huan YANG

Huan YANG, M.D., Senior Reviewer from Center for Drug Evaluation, CFDA. 

Since 2002, she has conducted a clinical professional review of chemicals and biologicals at the Center for Drug Evaluation (CDE) of the China Food and Drug Administration (CFDA). She is a senior reviewer and clinical expert advocate in the clinical department of biological products, engaging in the clinical professional technical review of new drugs such as vaccines, blood diseases, gene and cell therapy. Also participated in the CFDA/CDE a number of drug registration review and approval of relevant policies and regulations, clinical guidelines and national research projects. At the same time bear the eleventh Pharmacopoeia Commission, the first member of the Advisory Committee of National Immunization Planning Member, and the Editorial Board of China New Drug. 

She engages in technical review of vaccine and investigational new drugs of blood diseases, gene and cell therapy.