颜崇超 博士

恒瑞临床数据科学中心负责人

颜崇超，DIA（中国）顾问委员会委员,中国临床数据管理学组（CDMC）成员，现任上海恒瑞临床数据科学中心副总经理。曾是辉瑞（中国）研发中心数据服务部的技术运营负责人，并在上海医药临床研究中心数据管理部任高级总监。先后在美国勃林格殷格翰从事临床研究数据管理工作，以及在意大利高级卫生研究院，美国亚利桑那大学医学院和纽约大学医学院从事医学研究。在国内外期刊上发表过40余篇学术论文。《医药临床研究中的数据管理》书作者，北京，科学出版社，2011。

唐雪

辉瑞中国药物安全团队亚太区负责人

Jan PETRACEK 医学博士

英国PrimeVigilance公司首席执行官

Jan Petracek, MD, MSc • CEO • European Pharminvent Services, Czech Republic Dr. Jan Petracek qualified as a physician from Charles University in Prague and holds a Master of Science with Distinction in Quality and Safety in Healthcare from Imperial College London. Jan has over 15 years of experience in all areas of pharmacovigilance, being former Head of Risk Management Section at European Medicines Agency, Head of Pharmacovigilance in the Czech Republic, Head of Strategy and Development of the Czech National Authority, and member of CHMP Pharmacovigilance Working Party. He has established guidelines and registries for PASS at national level back in 2003, and since then he was involved in development of standards and regulations surrounding non-interventional studies in safety areas.

祝蓉 医学博士

缔脉生物医药科技有限公司 药物安全与药物警戒部门负责人

祝蓉博士是缔脉生物医药科技有限公司药物安全与药物警戒部门负责人，负责为生物医药企业提供药物警戒法规咨询、体系搭建和战略规划，领导团队提供全面的不良事件报告处理、安全性数据评估和风险管理、上市后药物安全性监测等一体化药物警戒解决方案。 祝蓉于复旦大学上海医学院（原上海医科大学）获得临床医学博士学位。 加入缔脉前，祝蓉就职于辉瑞公司全球药物安全部，安全评估与报告部门，担任药物安全医学总监。在此职位上她主要负责肿瘤治疗领域相关产品的安全性数据评估，包括个例安全报告的医学审核、定期汇总性安全报告的审阅、做为所负责产品的风险管理委员会成员进行安全信号评价和风险评估。 在进入医药行业之前，祝蓉先后在上海市第一人民医院和上海市中山医院从事临床和科研工作。

Sonja BRAJOVIC 医学博士

美国FDA监管科学医学官

Sonja Brajovic is a Medical officer in the Office of Surveillance and Epidemiology (OSE), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA). She is responsible for coordination of projects related to the Medical Dictionary for Regulatory Activities (MedDRA), including monitoring MedDRA coding quality of reports in the FDA Adverse Event Reporting System (FAERS). Sonja serves as the Regulatory Chair on the ICH* MedDRA Points to Consider workgroup and she is the FDA representative on the CIOMS** Implementation workgroup on Standardised MedDRA Queries (SMQs). Sonja obtained her medical degree in former Yugoslavia. --ICH: International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use --CIOMS: Council for International Organisations for Medical Sciences