唐轶 博士

  • 世界卫生组织驻华代表处(北京)


机构:世界卫生组织驻华代表处(北京)

职务:扩大免疫计划组项目官员

简介:

唐轶博士自2014年4月开始至今于扩大免疫计划组任项目官员。作为在世界卫生组织驻华代表处的工作职责,唐轶博士在世卫总部预认证审评团队的支持下启动了中国疫苗预认证推动项目,并在过去四年多的时间里协助中国研发和生产的疫苗进行准备和提交世卫组织预认证申请相关的工作,其中包括:对疫苗开展调查,帮助疫苗生产厂家制定战略规划以及技术路线图,定期协调和安排待申报疫苗向世卫预认证审评团队进行技术咨询,在技术上支持并跟进预认证申请准备和提交的进度,跟进和确认预认证通过后落实有关技术承诺,以及协调世卫组织与中国国家监管机构的沟通与协作,开展信息分享,同时参与世卫组织与中国国家药监职能部门的技术合作,参与并协调国家监管体系在包括疫苗在内的医药制品监管的强化及与国际规范接轨的建设。

加入世卫组织驻华代表处之前,唐轶博士在一家国际非政府组织北京代表处担任项目官员,工作时间七年,期间负责该组织与中国开展合作的疫苗相关项目,其中包括中国首个通过世卫预认证的疫苗项目,即中国生物技术集团公司成都生物制品研究所有限责任公司生产的乙脑疫苗。

更早之前,唐轶博士曾在多家合资和国内医药企业工作十年左右,工作范围涉及化学药物和生物制剂的临床试验,注册研究,医学事务和注册事务等领域。

唐轶博士于1997年获得首都医科大学心血管内科专业的临床医学博士学位,早先分别在1991年和1994年完成首都医科大学医学本科和内科学临床医学硕士研究生的学习和研究,并且在北京朝阳医院完成五年的全日制临床医学硕士和博士研究生培养和训练以及担任内科临床医生和心血管内科医生工作。

Bio for Yi Tang, M. D.

Dr Yi Tang has been working in EPI team of WHO China office as a National Professional Officer for vaccine prequalification since April 2014.

When carrying out his duties in WHO China office, Dr Tang initiated the WHO prequalification advancing project for Chinese vaccines with direct support from WHO vaccine prequalification assessment team in WHO Headquarters; the project supported and facilitated preparing for and submitting WHO prequalification for vaccine products developed and manufacture from China during the past four years, this include investigation to potential Chinese vaccine candidates for WHO prequalification submission, strategic planning and technical roadmap defining with vaccine manufacturers for the candidate vaccines, coordinate and facilitate periodic technical consultation for the candidate vaccines with WHO vaccine prequalification assessment team, technical support to and also follow up with progress of the prequalification submission preparation, follow up and confirm technical commitments for prequalified vaccines, coordinate the communication and collaboration between WHO vaccine prequalification assessment team with China national regulatory authorities (NRA) on vaccine, information sharing with institutions and international organizations; Dr Tang was also involved in the technical collaboration between WHO and China NRA, coordinate and participate the strengthening of NRA functions in regulation of medical products including vaccines and standardization with international operations.

Before working in WHO China office, Dr Tang worked as a program officer in an international NGO Beijing office for 7 years, and was responsible for vaccine projects that collaborating with Chinese partners; one of his responsibilities was working in the project of SA 14-14-2 live attenuated Japanese Encephalitis vaccine which was the first WHO prequalified Chinese vaccine, manufactured by Chengdu Institute of Biological Products Company Limited (CDIBP) affiliated China National Biotech Group (CNBG) submitting WHO prequalification.

Dr Tang worked in several joint venture and local pharmaceutical companies for another 10 years before he worked in the NGO, he was in charge of the registration clinical studies and regulatory affairs.

Dr Tang graduated from Capital University of Medical Sciences in 1997 as a Medical Doctor in clinical Cardiology, before which time he studied in the same University for 11 years and graduated in 1991 for Medical Bachelor’s degree and 1994 for Medical Master’s degree in internal clinical medicine, respectively; Dr Tang has completed the five years full-time studying and training of both medical Master’s and Doctor’s degree in Beijing Chaoyang Hospital while working in the general internal department and department of cardiovascular diseases of the hospital as a physician.