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分会场0901:从监管部门和生产企业角度如何改善临床试验中的安全性报告

(三层, 305CD)

时间: 05 月 24 日 08:30 - 10:00
内容介绍:

分会场联席主持人


林钦

默沙东研发(中国)有限公司药物安全部中国区负责人、总监


张轶菁

拜耳中国药物警戒中国区负责人


药物临床试验期间重要安全性数据管理,保障受试者安全,推动药品临床试验标准国际接轨,临床试验中药物安全报告和监测问题越来越受到重视。本分会场邀请到来自国家药监机构和生产企业的专家,分别从不同的视角和实践经验分享如何更好的进行临床试验中安全性数据报告和监测。


大型制药企业在执行美国FDA关于个案病例快速报告规则中的经验分享


Nina STUCCIO

默克实验室医学安全审评和临床试验安全报告副总裁


临床试验中安全性监测


任曙光

拜耳医药保健有限公司国际药品安全行政总监

日程嘉宾
2018第十届DIA中国年会
林钦
默沙东研发(中国)有限公司药物安全部中国区负责人、总监
Qin Lin has 15 years of experience in the biopharmaceutical industry and is currently the China PV lead at MSD. As internist and cardiologist, she worked in the hospital for three years. With clinical experience she joined in the clinical operation team in CMIC in 2003. During her 5 years at CMIC, she took CRA, CPM and CQM roles to successfully complete several clinical trials. And in 2008, she joined MSD China PV team and is responsible for local PV actives in China. Qin is MSD China PV lead for four years.
2018第十届DIA中国年会
Nina STUCCIO
默克实验室医学安全审评和临床试验安全报告副总裁
Nina Stuccio, D.O. has over 15 years of experience in the biopharmaceutical industry and is currently the Global Head of Medical Safety Review and Clinical Trial Safety Reporting at MSD. An internist and nephrologist, with experience as a clinical trial investigator and emergency medicine, she joined the biopharmaceutical industry in 2002 as a Medical Safety Review physician at Janssen/Johnson & Johnson. During her 11 years at Amgen, she provided medical safety support for marketed and late development products as Executive Medical Director, Therapeutic Area Head and Global Safety Officer, General Medicine and Bone prior to leading the successful implementation of a new global safety database. She was then Head of Quality Management for Global Regulatory Affairs and Safety at Amgen prior to joining MSD in 2014 as Global Head of Medical Safety Review and Clinical Trial Safety Reporting. Nina was the Clinical Safety & Risk Management Oncology Therapeutic Area Lead for two years prior to returning to her current role.
2018第十届DIA中国年会
任曙光
拜耳医药保健有限公司国际药品安全行政总监
任曙光 (Dawn Ren): 目前职位:拜耳制药,国际药品安全行政总监 (Global Safety Leader) 1995年毕业于哈尔滨医科大学。在妇产科临床工作8年。2005年进入制药行业,先后在默沙东、罗氏及拜耳从事临床试验数据管理和药物警戒工作。至今在药物警戒领域工作11年,其中7年在药品安全风险管理领域(risk management),负责在研药物和上市后药物的获益风险评估 (benefit risk assessment),发现新药的安全性特性(safety profile), 对已上市药物进行信号探测 (signal detection),制定风险管理计划 (risk management plan) 和风险最小化措施 (risk minimization measures)等。