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0906 | 药物警戒中的真实世界数据

时间: 05 月 23 日 10:30 - 12:00
内容介绍:

分会场主持人

周凌芸

赛诺菲全球药物警戒部亚太区药物警戒负责人, 总监


中国真实世界安全性评价的经验和实例

詹思延

北京大学公共卫生学院流行病和生物统计系主任


真实数据中的药物安全评估

陈建炜

台大医院医学研究部主任


美国和欧盟使用真实世界的数据来评估的风险最小化干预措施

莫京平 医学博士

辉瑞全球安全和法规流行病学高级总监


日程嘉宾
2019 DIA中国年会/ 2019 DIA China Annual Meeting
周凌芸
赛诺菲中国及亚太区安全负责人
周凌芸在赛诺菲拥有超过20年的业内经验,其中17年致力于中国及公司全球范围的药物警戒领域工作。她曾担任产品经理、内科及心血管治疗领域医学事务部经理、临床安全官、中国药物警戒负责人,国际药物警戒亚太区协调员和全球药物安全官。 周凌芸于1993年毕业于交通大学医学院,在加入制药行业之前曾担任外科医生。她还于2003年获得了中国执业药师证书,并于2012年取得了复旦大学公共卫生硕士学位。此外,周凌芸还是中国研发中心制药协会委员会药物警戒工作组成员、2014和2018年国际药物警戒协会年会科学委员会成员,及国际药物警戒协会中国分会主要成员。
2019 DIA中国年会/ 2019 DIA China Annual Meeting
詹思延
北京大学公共卫生学院流行病和生物统计系主任
教授、博导,北京大学公卫学院流行病与卫生统计学系主任,北医三院临床流行病学研究中心主任。中国药学会常务理事、药物流行病学专委会主任委员;中华预防医学会流行病学分会副主任委员。担任《药物流行病学杂志》主编、《中华流行病学杂志》副主编、《流行病学》统编教材第7、8版主编、长学制《临床流行病学》第2版主编。近年来承担科技部、国自然等多项课题,作为第一完成人获多项省部级奖励。2016年获第17届吴杨奖、2017年获北京市优秀教师称号。
2019 DIA中国年会/ 2019 DIA China Annual Meeting
陈建炜
台大医院医学研究部主任
Dr. Chan is a physician epidemiologist with 30 years of global research experience in academia and private sector, with a primary focus on post-marketing evaluation of pharmaceutical agents and vaccines. He received medical training at NTU in Taipei (MD-equivalent, 1987) and advanced training in epidemiology at Harvard School of Public Health (Doctor of Science, 1992). He served on the faculty at NTU (1993-1998) and Harvard School of Public Health (1998 - 2005) and joined the private industry in 2005, subsequently became the Chief Scientist of the Epidemiology Unit at Optum. Dr. Chan returned to NTU in 2013 and is currently a professor at NTU College of Medicine, Director of the NTU Health Data Research Center, and Director of Medical Research Department at NTU Hospital. In addition to scientific research, he has provided consulting input to Taiwan Food and Drug Administration and related health authority for more than 20 years. Dr. Chan has authored or co-authored more than 100 peer-reviewed articles and co-edited one of the two widely used English textbook on pharmacoepidemiology
2019 DIA中国年会/ 2019 DIA China Annual Meeting
莫京平
医学博士
 Peking University, Master degree in Bio-statistics; Tongji Medical College of HUST, Bachelor degree in Preventive Medicine  15 years biometric experience  Rich experience in DM work of many multi-regional clinical trials  Rich experience in the management of EDC/paper projects conduction, IWRS/drug supply system, and third-party vendors including Central Lab, ePRO, ERT, Central Reading etc.  Served for Covance, Pfizer, and Chiltern as the DM lead  Speaker for DIA seminar and CFDA training course