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分会场0506-2:随机对照还是真实世界–监管决策中的临床证据:第二部分

(二层, 203CD)

时间: 05 月 25 日 10:30 - 12:00
内容介绍:

分会场主持人


戴鲁燕 博士

和铂生物医药临床开发执行总监


随着真实世界证据(RWE)理念和技术的发展,关于RWE的利用,尤其是RWE如何支持随机对照试验的讨论日益激烈。随机对照试验(RCT)中最核心的内容是什么?RWE能够帮助甚至取代RCT吗?监管决策中对RWE的考量是什么?在本分会(第二部分)中,我们将重点关注监管决策中真实世界数据的使用,以及RWE在中国的现实状态,机遇和挑战。


真实世界数据和药物安全评估– PMDA指南和经验


宇山佳明 博士

日本药品与医疗器械管理局(PMDA)医学信息学和流行病学部部长


中国真实世界数据现状,机遇和挑战


谢洋

IQVIA大中华区真实世界洞察负责人,管理咨询资深总监


嘉宾讨论 – 随机对照试验和真实世界数据结合中的考量


讨论嘉宾


分会场0505-2及0506-2全体讲者

日程嘉宾
2018第十届DIA中国年会
戴鲁燕 博士
勃林格殷格翰泛亚太生物统计负责人
Dr. Luyan Dai is currently heading the Asia statistics group overseeing both teams in China and Japan and contributing to the global development at BI. She was relocated to Asia in 2012 to build up the statistics team in Shanghai for Boehringer Ingelheim. Prior to this, she worked at Boehringer Ingelheim in USA. Dr. Luyan Dai received her PhD in statistics at the University of Missouri-Columbia, USA.
2018第十届DIA中国年会
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.
2018第十届DIA中国年会
谢洋
IQVIA大中华区真实世界洞察负责人,管理咨询资深总监
Dr. Xie leads the Real-World Evidence and Health Economics and Outcomes Research work at IQVIA (f.k.a. QuntilesIMS) for Greater China. He has more than 15 years of experience teaching and conducting research in real-world evidence, health economics and health policy research. Before IQVIA, Dr. Xie had been in different roles in research consulting, MNC Pharma and academia. He had served as General Manager for Pharmerit Chima, Regional Head of Real-World Evidence for MSD Asia Pacific and Emerging Markets, and Assistant Professor for Health Services Research at University of Iowa. Dr. Xie has published more than 20 manuscripts and book chapters in health services research, health economics and health policy. He had also been invited as guest speaker at Harvard University, University of Michigan, Peking University and China Pharmaceutical University. Dr. Xie holds PhD in Economics and MPH from State University of New York at Stony Brook.