郭翔 博士

中国统计负责人/执行总监，百济神州

郭翔博士毕业于美国北卡州立大学（NCSU）统计系，目前是百济神州中国统计负责人，执行总监。加入百济之前，郭翔博士于2013-2017年担任默沙东实验室生物统计亚太负责人，高级总监，领导默沙东中国位于北京和上海的生物统计团队。在加入默沙东中国之前，郭翔博士曾于赛诺菲美国研发中心和中国研发中心担任高级统计经理以及来得时（LANTUS）项目统计负责人。 郭博士的研究兴趣主要集中在缺失数据的统计方法，适应性临床研究设计和国际多中心研究设计与分析等研究领域。郭博士目前是药物信息协会（DIA）中国统计分会主席，DIA 中国顾问委员会成员，中国临床研究统计专家组（CCTS）成员和北京生物统计和数据管理研究会（BBA）秘书长。

宇山佳明 博士

日本药品与医疗器械管理局医学信息学和流行病学部部长

Director, Office of Medical Informatics and Epidemiology, Pharmaceuticals and Medical Devices Agency Dr. Uyama is currently Director, Office of Medical Informatics and Epidemiology, Pharmaceuticals & Medical Devices Agency, Japan. He received his PhD degree and became a research fellow for the promotion of science within Japanese society. He was a post-doctoral fellow at the University of Calgary (Canada) from 1994 – 1995 and researcher in the Tokyo Metropolitan Institute of Medical Science from 1995 – 1998). Dr. Uyama joined the Ministry of Health and Welfare (now the Ministry of Health, Labour and Welfare) as a technical officer in 1998. In 2001, he started new drug review in the Pharmaceuticals and Medical Devices Evaluation Center of National Institute of Health Science, and has continued his career in drug review for the Pharmaceuticals and Medical Devices Agency since April 2004. His extensive experience in the review and safety assessment of new drugs includes serving as the Review Director (2007 – 2010); International Conference on Harmonisation Technical Coordinator (2004 – 2009); ICH E15 and E16 topic leader (2011 – 2012); Division Director for Regulatory Science Research (2011 – 2012); Division Director of Review Planning and Pharmaceutical Affairs Consultation (2012 –2013); Director, Division of Epidemiology (2014); and as Rapporteur of the International Conference on Harmonisation E17 Expert Working Group (2014). Dr. Uyama received his PhD degree from the Nagoya City University in 1994.

陈刚 博士

诺思格（北京）医药科技股份有限公司首席科学官，高级副总裁 北京大学临床研究所客座教授

陈博士于1992-2016年分别在制药工业，监管机构和学术界/临床研究机构任职。在FDA肿瘤药物评审中心生物统计部门任负责人近8年。2003-2013年在强生公司任肿瘤药物研发统计部负责人。2013-2016任强生公司中国研发定量科学部负责人。2013-2016任强生公司中国研发定量科学部负责人。过去6年里同监管部门，工业界及学术界生物统计学部的同事一起在MRCT、一致性研究、桥接试验方面做了大量的研究工作并发表很多重要论文。陈刚博士以其药物研发审评人和申办方双重角色的经历，在药物研发过程中积累了丰富的理论和实践经验。

Inger MOLLERUP

瑞士诺和诺德公司CMR药政顾问

More than 25 years’ experience in Drug Development and more than 12 years Regulatory Affairs experience with global regulatory responsibility for a number of drug development projects. Experienced in developing and leading regulatory strategy and implementation toward the NDA approval and life-cycle management. Has in that capacity overseen a number of license application and approval projects with multiple agency interactions in several regions of the world including USA (incl. Advisory Committee preparations), EU, Japan, China, Canada, India, Latin America and Southeast Asia. Has also held the project leadership responsibility for conducting a CVOT interim analysis to support regulatory decisions. Internationally recognized expert in biologics including biosimilars and represents Novo Nordisk in scientific and regulatory questions on biosimilar products. Has in that capacity been active in science-based policy engagement with regulators, legislators and industry trade organizations (including EMA/WHO/IABS/HC/FDA/US Congress with presentations at EMA and WHO workshops as well as testifying to the US Government Oversight and Reform Committee) and presented in numerous scientific conferences as well as agency led meetings and workshops. Broad leadership experience covering line management as well as global project management encompassing both quality, nonclinical and clinical areas.

王涛

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