Referencia Curso:
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British Association of Research Quality Assurance (BARQA) (2003) Good Clinical Laboratory Practice Version 1 (available as World Health Organization (2009) Good Clinical Laboratory Practice) 19 March 2015
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Division of AIDS (DAIDS) (2013) DAIDS Guidelines for Good Clinical Laboratory Practice Standards: 19 March 2015
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European Medicines Agency (EMA) Good Laboratory Practice Compliance: 19 March 2015
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Global Health Technologies Coalition, 'Database for Regulatory Requirements':19 March 2015
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International Air Transport Association (IATA) (2015) Dangerous Goods Regulations (DGR): 19 March 2015
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International Conference on Harmonisation (1996) Harmonised Tripartite Guideline for Good Clinical Practice E6 (R1):19 March 2015
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International Conference on Harmonisation (2000) Harmonised Tripartite Guideline, Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients (Q7): 29 May 2015
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International Organization for Standardization (ISO): ISO/IEC 17025:2005 (BS EN ISO/IEC 17025:2005) - General Requirements for the Competence of Testing and Calibration Laboratories: 30 May 2015
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International Organization for Standardization (ISO): ISO 15189:2012 (BS EN ISO 15189:2012) - Medical Laboratories - Requirements for Quality and Competence: 30 May 2015
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Office for Human Research Protections (2015) International Compilation of Human Research Standards: 19 March 2015
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Organisation for Economic Co-operation and Development (OECD) (1998) Principles of Good Laboratory Practice and Compliance Monitoring: 19 March 2015
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Research Quality Association (RQA) (2012) Good Clinical Laboratory Practice (GCLP) Version 2: 19 March 2015
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Sarzotti-Kelsoe, M et al (2009) Evaluation and Recommendations on Good Clinical Laboratory Practice Guidelines for Phase I-III Clinical Trials. PLoS Med DOI: 10/journal.pmed.1000067: 19 March 2015
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The CRA Training Institute: Countries that follow ICH-GCP Guidelines for Clinical Trials: 19 March 2015
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US Food and Drug Administration (FDA) (2014) Good Laboratory Practice for Non Clinical Laboratory Studies: 19 March 2015
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Westgard, J. (2008) Basic Method Validation 3rd Edition: 30 May 2015
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World Health Organization (WHO) (2009) Handbook for Good Laboratory Practice (GLP) 2nd Edition: 19 March 2015
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World Health Organization (WHO) (2002) Handbook for Good Clinical Research Practice (GCP): 29 May 2015
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World Health Organization (WHO) (2003) Guidelines on good manufacturing practices for blood establishments (GMP): 30 May 2015
- World Health Organization (WHO) (2012) Guidance on regulations for the Transport of Infections Substances 2013-2014: 29 May 2015
Otros Recursos:
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Cancer Research UK Manchester Institute (2015) Challenges of the GCLP Environment: 29 May 2015
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European Commission for Public Health (2001) Clinical Trials Directive 2001/20/EC: 29 May 2015
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European Medicines Agency, Science Medicines Health. Good Clinical Practice Compliance: 29 May 2015
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Pharmacelsus Contract Research Organisation. GCLP: 19 March 2015
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Westgard et al (2010), Basic QC Practices, 3rd Edition: 30 May 2015
Materiales Donados:
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International Partnership for Microbicides (IPM) – ‘Good Clinical Laboratory Practice (GCLP) – Introduction to GCLP’ – Training materials
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Ken Awondo – Kenya Medical Research Institute (KEMRI) / Wellcome Trust Research Programme - GCLP training materials
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Pharmaceutical Product Development, LLC (2012) – GCLP traning materials
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Simon N Buhalata – ‘Minimum Requirements for Good Clinical Laboratory Practice – Good Clinical Laboratory Practices in Developing Settings’ – NIMR- Mwanza 13th June 2012