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0101 | 监管科学的新进展

时间: 05 月 22 日 08:30 - 10:00
内容介绍:

分会场主持人

苏岭 博士

沈阳药科大学教授,礼来亚洲基金风险合伙人


监管科学旨在研究应用于评价药品疗效、安全性、质量的新工具、新方法、新标准,对促进新药研发和提高监管水平起到极大的作用。近年来,国际主要药品监管机构在药品监管科学上的研究和成果应用引入注目,应对科学技术的飞速发展,加快新药审批,确保药品上市后

的风险获益。本分会场将邀请美、欧、日药品监管机构和我国国家药监局分享其在药品监管科学研究、合作与应用上的新进展,共同探讨如何提升监管能力和加强国际间合作。


美国FDA视角

Leigh VERBOIS 博士

美国FDA全球政策与战略办公室,全球运行办公室主任


欧盟EMA视角

Agnes SAINT-RAYMOND 医学博士

EMA国际事务及Portfolio Board负责人


日本PMDA视角

佐藤淳子 博士

PMDA国际项目办公室主任


日程嘉宾
2019 DIA中国年会/ 2019 DIA China Annual Meeting
苏岭
沈阳药科大学教授 礼来亚洲基金风险合伙人
苏岭博士在药品法规及注册审评管理、新药研发策略和管理、临床研究、药物安全和药物警戒、药物流行病学等领域拥有丰富经验。曾任职于原卫生部药政管理局和美国FDA,担任药物信息协会 (DIA) 全球理事会主席等职。先后在默沙东、罗氏、惠氏、诺华等多家跨国制药企业从事临床研究和药物研发的高级管理工作
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
佐藤淳子
日本PMDA国际项目办公室主任
Dr. Junko Sato is an Office Director of Office of International Program at Pharmaceuticals and Medical Devices Agency (PMDA). She joined Regulatory Agency in 1998. She became a review director of Office of New Drug in 2004 and moved to Office of Safety in 2009 to develop a new risk management system through life cycle of drugs. During the period, she visited U.S.FDA as a guest reviewer from September 2002 to March 2003. From May 2012 to April 2014, she was dispatched to EMA as MHLW/PMDA Liaison. She enhanced collaboration between EMA and MHLW/PMDA and brought a huge success as the liaison. She contributed to some global harmonization activities, for example, ICH, CIOMS etc. She also contributes many DIA activities. She received DIA Outstanding Service Award 2010. She led the activities of PMDA Asia Training Center for Pharmaceuticals and Medical Devices Regulatory Affairs (PMDA-ATC) including planning/conduct of all the trainings, and contributes to building stronger bilateral relationship with ASEAN countries by playing the role as the contact point. She also works for AMR project like EMA-FDA-PMDA tripartite meeting to discuss convergence on approaches for the evaluation of antibacterial drugs. She is an Infection Control Doctor certificated by The Japanese Association of Infectious Disease.