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1005 | 全球视角的患者参与

时间: 05 月 23 日 08:30 - 10:00
内容介绍:

分会场主持人

David YOSHII

精鼎全球Site Solutions高级总监


加强患者在证据生成中的相关性 - EMA视角

Agnes SAINT-RAYMOND 医学博士

EMA国际事务及Portfolio Board负责人


实施以患者为中心的创新举措: 患者数据访问倡议和全球试验发现者

李俊

强生公司亚太区合规总监


以患者为中心的研究设计

David YOSHII

精鼎全球Site Solutions高级总监


日程嘉宾
2019 DIA中国年会/ 2019 DIA China Annual Meeting
David Yoshii
Senior Director, Global Site Solutions PAREXEL International
David Yoshii is the Senior Director for Global Site Solutions, covering feasibility, patient recruitment, site alliances, and other site related strategies for PAREXEL’s valued clients. His career spans over 20 years in drug development in various global leadership roles in the United States and Asia. He joined PAREXEL in 2011, and is currently based in Tokyo.
2019 DIA中国年会/ 2019 DIA China Annual Meeting
Agnes Saint-Raymond
EMA国际事务及Portfolio Board负责人
Head of International Affairs (ad interim), Head of Portfolio Board MD and qualified Paediatrician. Chef de Clinique in Paed. in Necker-Enfants-Malades Hospital (Paris, 1985-1990). Joined French Agency for medicines (now ANSM) in 1995 as Head of a Pharmaco-Toxico-Clinical Assessment Unit. Joined EMA in 2000. Head of Special Areas for Human Medicines (Paediatric Medicines, Orphan Medicines, Scientific Advice, SME Office, and Scientific Support & Projects) until 2013. Head of Portfolio Board since Aug 2013. Head of International Affairs (a.i.) since Nov 2016.
2019 DIA中国年会/ 2019 DIA China Annual Meeting
李俊
Asia Pacific Director of Regulatory Compliance,BioResearch Regulatory Compliance, J&J
• Dr. Jun Li, APAC Director of Regulatory Compliance, Johnson & Johnson (Johnson & Johnson Pte Ltd., 2 Science Park Drive, #07-13 Ascent, Singapore Science Park 1, Singapore 118222 Tel: 9732 4390) • Current key responsibilities: - o Managing health authority inspections o Providing consultation and advice on quality & compliance • Previous work experience etc.: - o Worked for GSK in Clinical Development QA as Mgr., primarily responsible for the QA audit program implementation, and quality consultation and advice o Worked for Novartis in Clinical QA as Site Head, primarily responsible for the QA audit program strategy and implementation, and quality/compliance consultation, training and advice o Worked for Royal Free Hospital School of Medicine as Post-doc. Research Fellow, primarily responsible for research work and some teaching • Outside designation: - o Chairman of South East Asia Regional Forum, Research Quality Association (RQA) • Educational background: - o PhD in Child Health, University of London, UK o MSc in Public Health, University of London, UK o MMedSc in Paediatrics, Tongji Medical University, China o BSc in Paediatrics, Tongji Medical University, China