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A call to incorporate systems theory and human factors into the existing investigation of harm in clinical research involving healthcare products.
Edwards, Brian D; Bégaud, Bernard; Daemen, Esther; Dokas, Ioannis; Fishbein, Jonathan M; Greenberg, Howard E; Hochberg, Alan; Le Louet, Hervé; Lyngvig, Jytte; Mogles, Nataliya; Owen, Kathryn; Prendergast, Christine; Rejzek, Martin; Trantza, Sophia; Webb, David J; Whalen, Matthew; Whiteley, Simon.
Afiliação
  • Edwards BD; Principal Consultant NDA Regulatory Science Ltd and Vice-President Alliance Clinical Research Excellence & Safety, Leatherhead, UK.
  • Bégaud B; Département de Pharmacologie Médicale, Université de Bordeaux, France.
  • Daemen E; Clinical Research Professional, TRIUM Clinical Consulting NV, Ghent, Belgium.
  • Dokas I; Civil Engineering Department, Democritus University of Thrace, Xanthi, Greece.
  • Fishbein JM; Safety and Commercialization Services at PRA Health Sciences, Philadelphia, USA.
  • Greenberg HE; Janssen Research and Development, LLC, Titusville, NJ, USA.
  • Hochberg A; Pharmacology & Experimental Therapeutics, Thomas Jefferson University, Philadelphia, USA.
  • Le Louet H; F. Hoffmann-La Roche Ltd., Basel, Switzerland.
  • Lyngvig J; Head of Pharmacovigilance Fédération Assistance Publique Hôpitaux de Paris, President of Council for International Organizations of Medical Sciences, Past President of International Society of Pharmacovigilance, Pharmacovigilance Risk Assessment Committee (PRAC) member, Paris, France.
  • Mogles N; Past Senior Vice President and Managing Director Europe, Middle East and Africa, Drug Information Association, Past Executive Director, Danish Medicines Agency, Copenhagen, Denmark.
  • Owen K; Research Associate Department of Computer Science University of Bath, Bath, UK.
  • Prendergast C; Fellow of the Faculty of Pharmaceutical Medicine, Managing Director of Owen Clinical Consulting Ltd., Manchester, UK.
  • Rejzek M; Marketed Product Safety Services, Quintiles IMS, Dublin, Ireland.
  • Trantza S; Deputy Head of the Safety-Critical Systems Research Lab, Zurich University of Applied Sciences (ZHAW), Zurich, Switzerland.
  • Webb DJ; Department of Adverse Reactions, Division of Clinical Trials, National Medicines Agency (EOF), Athens, Greece.
  • Whalen M; Clinical Pharmacology Unit, University of Edinburgh, Edinburgh, UK.
  • Whiteley S; Alliance for Clinical Research Excellence and Safety (ACRES), Baltimore, USA.
Br J Clin Pharmacol ; 83(11): 2339-2342, 2017 Nov.
Article em En | MEDLINE | ID: mdl-28681444
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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Teoria de Sistemas / Atenção à Saúde / Melhoria de Qualidade / Farmacovigilância / Experimentação Humana Idioma: En Ano de publicação: 2017 Tipo de documento: Article
Texto completo
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XML
PubMed Links
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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Teoria de Sistemas / Atenção à Saúde / Melhoria de Qualidade / Farmacovigilância / Experimentação Humana Idioma: En Ano de publicação: 2017 Tipo de documento: Article