Referencia Curso:

  1. 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

  2. Division of AIDS (DAIDS) (2013) DAIDS Guidelines for Good Clinical Laboratory Practice Standards: 19 March 2015

  3. European Medicines Agency (EMA) Good Laboratory Practice Compliance: 19 March 2015

  4. Global Health Technologies Coalition, 'Database for Regulatory Requirements':19 March 2015

  5. International Air Transport Association (IATA) (2015) Dangerous Goods Regulations (DGR): 19 March 2015

  6. International Conference  on Harmonisation (1996) Harmonised Tripartite Guideline for Good Clinical Practice E6 (R1):19 March 2015

  7. International Conference  on Harmonisation (2000) Harmonised Tripartite Guideline, Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients (Q7): 29 May 2015

  8. 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

  9. International Organization for Standardization (ISO): ISO 15189:2012 (BS EN ISO 15189:2012) - Medical Laboratories - Requirements for Quality and Competence: 30 May 2015

  10. Office for Human Research Protections (2015) International Compilation of Human Research Standards: 19 March 2015

  11. Organisation for Economic Co-operation and Development (OECD) (1998) Principles of Good Laboratory Practice and Compliance Monitoring: 19 March 2015

  12. Research Quality Association (RQA) (2012) Good Clinical Laboratory Practice (GCLP) Version 2: 19 March 2015

  13. 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

  14. The CRA Training Institute: Countries that follow ICH-GCP Guidelines for Clinical Trials: 19 March 2015

  15. US Food and Drug Administration (FDA) (2014) Good Laboratory Practice for Non Clinical Laboratory Studies: 19 March 2015

  16. Westgard, J. (2008) Basic Method Validation 3rd Edition: 30 May 2015

  17. World Health Organization (WHO) (2009) Handbook for Good Laboratory Practice (GLP) 2nd Edition: 19 March 2015

  18. World Health Organization (WHO) (2002) Handbook for Good Clinical Research Practice (GCP): 29 May 2015

  19. World Health Organization (WHO) (2003) Guidelines on good manufacturing practices for blood establishments (GMP): 30 May 2015

  20. World Health Organization (WHO) (2012) Guidance on regulations for the Transport of Infections Substances 2013-2014: 29 May 2015

 

Otros Recursos:

  1. Cancer Research UK Manchester Institute (2015) Challenges of the GCLP Environment: 29 May 2015

  2. European Commission for Health and Consumers Directorate General (2013) The Rules Governing Medicinal Prodycst in the European Union (vol. 10) Guidance Documents applying to Clinical Trials: 29 May 2015

  3. European Commission for Public Health (2001) Clinical Trials Directive 2001/20/EC: 29 May 2015

  4. European Commission for Public Health (2014) Clinical Trials – Regulations EU No 536/2014: 29 May 2015

  5. European Medicines Agency, Science Medicines Health. Good Clinical Practice Compliance: 29 May 2015

  6. Medicines and Healthcare Products Regulatory Agency (MHRA) (2014) Good Clinical Practice for Clinical Trials:  29 May 2015

  7. Medicines and Healthcare Products Regulatory Agency (MHRA) (2014) Good Clinical Practice: Guidance and Inspections: 19 March 2015

  8. Pharmacelsus Contract Research Organisation. GCLP: 19 March 2015

  9. Todd C et al (2014): Implementation of Good Clinical Laboratory Practice within the External Quality Assurance Program Oversight Laboratory (EQAPOL): Journal of Immunological Methods Vol 409 pp91-98:  19 March 2015

  10. University of Liverpool Institute of Translational Medicine. Liverpool GCLP Facility: Good Clinical Laboratory Practice: 19 March 2015

  11. Westgard et al (2010), Basic QC Practices, 3rd Edition: 30 May 2015

 

Materiales Donados:

  1. International Partnership for Microbicides (IPM) – ‘Good Clinical Laboratory Practice (GCLP) – Introduction to GCLP’ – Training materials

  2. Ken Awondo – Kenya Medical Research Institute (KEMRI) / Wellcome Trust Research Programme - GCLP training materials

  3. Pharmaceutical Product Development, LLC (2012) – GCLP traning materials

  4. Simon N Buhalata – ‘Minimum Requirements for Good Clinical Laboratory Practice – Good Clinical Laboratory Practices in Developing Settings’ – NIMR- Mwanza 13th June 2012