1Institute of Clinical Pharmacology, Central South University, Changsha 410078, Hunan, China; 2Anhui Provincial Center for Drug Clinical Evaluation, Yijishan Hospital of Wannan Medical College, Wuhu 241001, Anhui, China; 3Barton Cobert, President BLCMD Associates, LLC Westfield, NJ USA
About author:Barton Cobert MD, FACP, FACG, FFPM E-mail:bcobert@blcmd.com www.blcmd.com. Barton Cobert, has had a long, distinguished career in pharmacovigilance, drug safety and risk mangement. He was senior director pharmacovigilance for Schering-Plough Research Institute and held similar positions for Novartis Consumer Health Inc. and Medidata Solutions. He has represented his company and PhRMA at many international meetings and organizations including ICH. Dr. Cobert received his MD from New York University School of Medicine in Manhattan. He haswritten and lectured extensively on pharmacovigilance. He has written three books on drug safety including theManual of Drug Safety and Pharmacovigilance which is used as a textbook in courses on drug safety. Dr. Cobert is president of BLCMD Associated LLC, a drug safety and pharmacovigilance consulting company inWestfield, NJ.
XIE Hai-tang, BARTON Cobert, SUN Rui-yuan. Drug safety registries-are they useful?[J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2009, 14(1): 1-4.
[1] 国家食品药品监督管理局.药品注册管理办法(局令第28 号) [S]. 2007-07-10.药品注册管理办法(局令第28 号) [S]. 2007-07-10.http://www.sda.gov.cn/WS01/CL0053/24529.html. [2] Moore TJ, CohenMR, Furberg CD.Serious adverse drug events reported to the Food and Drug Administration, 1998-2005[J]. Arch InternMed, 2007, 167(16):1752-1759. [3] EURAP Study Group.Seizure control and treatment in pregnancy:observations from the EURAP epilepsy pregnancy registry[J]. Neurology, 2006, 66(3):354-360. [4] 刘桂英, 徐立欣, 刘世梅, 等.肿瘤病人注册和数据管理系统的建立与应用[J]. 护理管理杂志, 2002, 2(2):13, 23. [5] Simon T, Verstuyft C, Mary-Krause M, et al. Genetic determinants of response to clopidogrel and cardiovascular events[J]. N Engl JMed, 2009, 360(4):363-375.
