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dc.creatorAltavilla, Annagraziaen
dc.date.accessioned2016-01-09T00:35:25Zen
dc.date.available2016-01-09T00:35:25Zen
dc.date.created2011-01en
dc.date.issued2011-01en
dc.identifierdoi:10.1163/157180911X546129en
dc.identifier.bibliographicCitationEuropean journal of health law 2011 Jan; 18(1): 65-75en
dc.identifier.urihttp://worldcatlibraries.org/registry/gateway?version=1.0&url_ver=Z39.88-2004&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&atitle=Ethical+standards+for+clinical+trials+conducted+in+third+countries:+the+new+strategy+of+the+European+Medicines+Agency.&title=European+journal+of+health+law+&volume=18&issue=1&date=2011-01&au=Altavilla,+Annagraziaen
dc.identifier.urihttp://dx.doi.org/10.1163/157180911X546129en
dc.identifier.urihttp://hdl.handle.net/10822/1019051en
dc.description.abstractClinical trials increasingly occur on a global scale as industry and government sponsors in wealthy countries move trials to low- and middle-income countries. The globalization of clinical research raises important questions about the economical and ethical aspects of clinical research and the translation of trial results to clinical practice: which ethical standards are applied? Are trials results accurate and valid, and can they be extrapolated to other settings? This article provides an overview of the strategy approved by the European Medicines Agency (EMA) to clarify ethical standards for clinical research conducted outside the European Economic Area (EEA) and included in Marketing Authorization Applications. Reference to the EMA Reflection paper is made.en
dc.formatArticleen
dc.languageenen
dc.sourceeweb:337010en
dc.subjectClinical Trialsen
dc.subjectClinical Researchen
dc.subjectGovernmenten
dc.subjectIndustryen
dc.subjectMarketingen
dc.subjectResearchen
dc.subjectStandardsen
dc.subject.classificationResearch on Foreign Nationalsen
dc.titleEthical Standards for Clinical Trials Conducted in Third Countries: The New Strategy of the European Medicines Agencyen
dc.provenanceCitation prepared by the Library and Information Services group of the Kennedy Institute of Ethics, Georgetown University for the ETHXWeb database.en
dc.provenanceCitation migrated from OpenText LiveLink Discovery Server database named EWEB hosted by the Bioethics Research Library to the DSpace collection EthxWeb hosted by DigitalGeorgetown.en


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