Titlebook: Clinical Trials in Latin America: Where Ethics and Business Clash; Nuria Homedes,Antonio Ugalde Book 2014 Springer International Publishin

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A Review and Critique of International Ethical Principles,nalyzes the different ethical codes that have been accepted by governments and professional associations in Latin American countries. After describing how the different international ethical research codes were drafted, have been changed and are being applied, the authors characterize the reasons wh

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Globalization and Clinical Research in Latin America,option of the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) and the approval of the Good Clinical Practice Guidelines from the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH GCP)..This chapter de

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The Regulatory Framework and Case Studies from Argentina,s and the responsibility for clinical trials rests in the provinces. Nevertheless the federal Ministry of Health and the regulatory agency (ANMAT) have a number of regulations and the country can be characterized as having an uneven but evolving legal infrastructure. This chapter describes the regul

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