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.

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.

谭凌实

缔脉生物医药科技（上海）有限公司董事长兼首席执行官 DIA全球董事会董事

Leigh VERBOIS

美国FDA全球政策与战略办公室，全球运行办公室主任

何如意

清华大学医学院教授 清华大学医学院医药监管科学研究中心学术委员会主任 国投创新医药健康首席科学家