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Chinese Journal of Clinical Pharmacology and Therapeutics ›› 2009, Vol. 14 ›› Issue (1): 1-4.

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Drug safety registries-are they useful?

XIE Hai-tang1,2, BARTON Cobert3, SUN Rui-yuan2   

  1. 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
  • Received:2009-01-31 Revised:2009-02-05 Online:2009-01-26 Published:2020-10-27
  • 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.

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Abstract: The collection of adverse drug events (ADE) represents one of the inherent attributes of qualified (approved) drugs. The awareness of drug safety problems, the evaluation of the impact of adverse factors, and thus the formulation of corresponding preventive measures will minimize the risk of taking medications. We introduce drug safety registries in referring to some of the latest information on the understanding of the concept of drug safety and related laws and regulations.

Key words: drug safety, registries, adverse drug events

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