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0106 | 海外监管热点话题

时间: 05 月 23 日 10:30 - 12:00
内容介绍:

分会场主持人

赵岩松

罗氏药品临床研发注册副总监


EMA PRIME项目 - 背后考量及案例分享

Agnes SAINT-RAYMOND 医学博士

EMA国际事务及Portfolio Board负责人


FDA实时肿瘤回顾及评估

高蓉

诺华药政事务部药政信息和能力建设负责人


数字化医疗中的产品信息 - 药物电子标签和AI辅助注册决策的作用

Karl GRAHAM-SIEGENTHALER

罗氏个性化健康全球注册总监


日程嘉宾
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
Karl Graham-Siegenthaler
罗氏个性化健康全球注册总监
Karl Graham-Siegenthaler is a Swiss-Canadian protein biochemist who brings over 25 years of research and healthcare industry experience to his role as Group Director for Personalized Healthcare in the Pharmaceutical Regulatory department at F. Hoffmann - La Roche Ltd. He has served in a variety of roles and functions with a focus on contributing drug development, diagnostic and regulatory innovation and delivering improved patient outcomes based on personalized molecularly-guided approaches to healthcare solutions. Karl has led the development and/or regulatory strategy for multiple major cancer therapies, is contributing to Roche’s strategy for Clinical Decision Support and is leading Roche’s exploration of how digital and AI-based regulatory approaches could help more effectively translate personalized healthcare insights into better patient care and health.