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Quality and Safety: Medicines

Quality Assurance

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Titre:	13th International Conference of Drug Regulatory Authorities (ICDRA) Berne, Switzerland, 16-19 September 2008. ICDRA: Medicines Agencies Decide Future Action
Sujets:	Quality and Safety: Medicines > Quality Assurance Quality and Safety: Medicines > Regulatory Support
An:	2008 Pages: 19
Éditeurs:	WHO Headquarters in Geneva
Liens associés:	http://www.who.int/medicines/areas/quality_safety/regulation_legislation/icdra/en/index.html
Régions:	Global

Titre:	14th International Conference of Drug Regulatory Authorities(ICDRA), Singapore 30 November - 3 December 2010
Sujets:	Quality and Safety: Medicines > Quality Assurance Quality and Safety: Medicines > Regulatory Support
An:	2011 Pages: 16
Éditeurs:	WHO Headquarters in Geneva
Liens associés:	http://www.who.int/medicines/areas/quality_safety/regulation_legislation/icdra/en/index.html

Titre:	Accelerated Stability Studies of Widely Used Pharmaceutical Substances Under Simulated Tropical Conditions
Sujets:	Quality and Safety: Medicines > Quality Assurance
An:	1986 Pages: 119
Éditeurs:	WHO Headquarters in Geneva
Régions:	Global

Titre:	Additional Guidance for Organizations Performing in Vivo Bioequivalence Studies. WHO Technical Report Series, No. 937, 2006, Annex 9
Sujets:	Quality and Safety: Medicines > Quality Assurance Prequalification of Medicines > WHO-UNICEF-UN Project
An:	2006 Pages: 23
Éditeurs:	WHO Headquarters in Geneva
Documents similaires:	WHO Expert Committee on Selection and Use of Essential Medicines - WHO Technical Report Series, No. 850, Annex 3 (Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products) - Sixth Report Proposal to Waive in Vivo Bioequivalence Requirements for WHO Model List of Essential Medicines Immediate-release, Solid Oral Dosage Forms. WHO Technical Report Series, No. 937, 2006, Annex 8
Régions:	Global

Titre:	Antimalarial Medicines in Kenya. Availability, Quality and Registration Status. A Baseline Study Undertaken Prior to Nationwide Distribution of Artemether-Lumefantine (AL) in Kenya
Sujets:	Medicine Information and Evidence for Policy > Medicines Policy Quality and Safety: Medicines > Quality Assurance
An:	2007 Pages: 41
Éditeurs:	WHO Country Office in Kenya Kenya Ministry of Health Health Action International - Africa
Régions:	EAC East African Community
Pays:	Kenya

Titre:	Application of Hazard Analysis and Critical Control Point (HACCP) Methodology to Pharmaceuticals. WHO Technical Report Series, No. 908, 2003, Annex 7
Sujets:	Quality and Safety: Medicines > Quality Assurance Quality and Safety: Medicines > Regulatory Support
An:	2003 Pages: 14
Éditeurs:	WHO Headquarters in Geneva
Régions:	Global

Titre:	Basic Tests for Drugs - Pharmaceutical Substances, Medicinal Plant Materials and Dosage Forms [French] [Spanish]
Sujets:	Quality and Safety: Medicines > Quality Assurance
An:	1998 Pages: 100
Éditeurs:	WHO Headquarters in Geneva
Régions:	Global

Titre:	Basic Tests for Pharmaceutical Substances [French] [Spanish]
Sujets:	Quality and Safety: Medicines > Quality Assurance
An:	1986 Pages: 216
Éditeurs:	WHO Headquarters in Geneva
Régions:	Global

Titre:	Considerations for Requesting Analysis of Drug Samples. WHO Technical Report Series, No. 902, 2002, Annex 4
Sujets:	Quality and Safety: Medicines > Quality Assurance
An:	2002 Pages: 4
Éditeurs:	WHO Headquarters in Geneva
Documents similaires:	Model Certificate of Analysis. WHO Technical Report Series, No. 902, 2002, Annex 10
Régions:	Global

Titre:	Development of Paediatric Medicines: Points to Consider in Formulation. WHO Technical Report Series, No. 970, 2012, Annex 5
Sujets:	Quality and Safety: Medicines > Quality Assurance
An:	2012 Pages: 29
Éditeurs:	WHO Headquarters in Geneva
Documents similaires:	WHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 970 - Forty-sixth Report (Geneva, 10–14 October 2011)
Liens associés:	http://www.who.int/medicines/areas/quality_safety/quality_assurance/guidelines/en/index.html http://www.who.int/childmedicines/en/
Régions:	Global

Titre:	Drug Quality Control Laboratories
Sujets:	Quality and Safety: Medicines > Quality Assurance
An:	1999 Pages: 42
Éditeurs:	World Health Organization - Regional Office for Africa (WHO/AFRO)
Documents similaires:	Report of a Meeting on the Optimal Use of Regional Drug Quality Control Laboratories in Africa
Régions:	Afrique (AFRO)

Titre:	Drug Quality Screening in Developing Countries: Establishment of an Appropriate Laboratory in Swaziland
Sujets:	Quality and Safety: Medicines > Quality Assurance
Auteur:	Kenyon, A.S.; Kenyon, T.A.; Sibiya, T.
An:	1994 Pages: 6
Éditeurs:	WHO Headquarters in Geneva
Pays:	Swaziland

Titre:	Série de Recherche [French] [Spanish]
Sujets:	Medicine Access and Rational Use > Financing Medicine Access and Rational Use > Rational Use Quality and Safety: Medicines > Quality Assurance
Éditeurs:	WHO Headquarters in Geneva

Titre:	Ensuring Quality Medicines: A Decade of Prequalification
Sujets:	Quality and Safety: Medicines > Quality Assurance Prequalification of Medicines > WHO-UNICEF-UN Project
Auteur:	van Zyl, A. J.
An:	2011 Pages: 9
Éditeurs:	WHO Headquarters in Geneva
Régions:	Global

Titre:	Framework for Implementation of Equivalence Requirements for Pharmaceutical Products. PANDRH Technical Report Nº 8, Pan American Network on Drug Regulatory Harmonization
Sujets:	Quality and Safety: Medicines > Quality Assurance
An:	2011 Pages: 38
Éditeurs:	World Health Organization - Regional Office for the Americas (WHO/AMRO/PAHO)
Régions:	Global; Amériques (AMRO)

Titre:	Good Manufacturing Practices for Biological Products. In: WHO Expert Committee on Biological Standardization. Forty-second Report. Geneva, World Health Organization, 1992 (WHO Technical Report Series, No. 822), Annex 1; and WHO Expert Committee on Specifications for Pharmaceutical Preparations. Thirty-second Report. Geneva, World Health Organization, 1993 (WHO Technical Report Series, No. 834), Annex 3
Sujets:	Quality and Safety: Medicines > Blood Products and Related Biologicals Quality and Safety: Medicines > Quality Assurance
An:	1992 Pages: 11
Éditeurs:	WHO Headquarters in Geneva
Documents similaires:	WHO Expert Committee on Biological Standardization - WHO Technical Report Series, No. 822 - Forty-second Report WHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 834 - Thirty-third Report
Liens associés:	http://www.who.int/medicines/areas/quality_safety/quality_assurance/production/en/index.html
Régions:	Global

Titre:	Good Manufacturing Practices: Supplementary Guidelines for the Manufacture of Investigational Pharmaceutical Products for Clinical Trials in Humans. WHO Technical Report, Series No. 863 , 1996, Annex 7
Sujets:	Quality and Safety: Medicines > Quality Assurance
An:	1996 Pages: 16
Éditeurs:	WHO Headquarters in Geneva
Liens associés:	http://www.who.int/medicines/areas/quality_safety/quality_assurance/production/en/index.html
Régions:	Global

Titre:	Good Manufacturing Practices: Supplementary Guidelines for the Manufacture of Pharmaceutical Excipients. WHO Technical Report Series, No. 885, 1999, Annex 5
Sujets:	Quality and Safety: Medicines > Quality Assurance
An:	1999 Pages: 22
Éditeurs:	WHO Headquarters in Geneva
Documents similaires:	WHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 885 - Thirty-fifth Report
Liens associés:	http://www.who.int/medicines/areas/quality_safety/quality_assurance/production/en/index.html
Régions:	Global

Titre:	Good Practices for Selecting and Procuring Rapid Diagnostic Tests for Malaria
Sujets:	Medicine Access and Rational Use > Supply Management Quality and Safety: Medicines > Quality Assurance
An:	2011 Pages: 109
Éditeurs:	WHO Headquarters in Geneva
Régions:	Global

Titre:	Good Procurement Practices for Artemisinin-Based Antimalarial Medicines
Sujets:	Medicine Access and Rational Use > Supply Management Quality and Safety: Medicines > Quality Assurance
An:	2010 Pages: 128
Éditeurs:	WHO Headquarters in Geneva
Régions:	Global

Titre:	Good Trade and Distribution Practices for Pharmaceutical Starting Materials. WHO Technical Report Series, No. 917, 2003, Annex 2
Sujets:	Quality and Safety: Medicines > Quality Assurance
An:	2003 Pages: 19
Éditeurs:	WHO Headquarters in Geneva
Documents similaires:	WHO Pharmaceutical Starting Materials Certification Scheme (SMACS): Guidelines on Implementation. WHO Technical Report Series, No. 917, 2003, Annex 3
Régions:	Global

Titre:	Guidance for Inspection of Drug Distribution Channels. WHO Technical Report Series, No. 885, 1999, Annex 6
Sujets:	Quality and Safety: Medicines > Quality Assurance Quality and Safety: Medicines > Regulatory Support
An:	1999 Pages: 21
Éditeurs:	WHO Headquarters in Geneva
Liens associés:	http://www.who.int/medicines/areas/quality_safety/quality_assurance/inspections/en/index.html
Régions:	Global

Titre:	Guidance on Good Manufacturing Practices (GMP): Inspection Report. WHO Technical Report Series, No. 908, 2003, Annex 6
Sujets:	Quality and Safety: Medicines > Quality Assurance
An:	2003 Pages: 5
Éditeurs:	WHO Headquarters in Geneva
Liens associés:	http://www.who.int/medicines/areas/quality_safety/quality_assurance/inspections/en/index.html
Régions:	Global

Titre:	Guidance on the Selection of Comparator Pharmaceutical Products for Equivalence Assessment of Interchangeable Multisource (Generic) Products. WHO Technical Report Series, No. 902, 2002, Annex 11
Sujets:	Quality and Safety: Medicines > Quality Assurance Quality and Safety: Medicines > Regulatory Support
An:	2002 Pages: 20
Éditeurs:	WHO Headquarters in Geneva
Liens associés:	http://www.who.int/medicines/areas/quality_safety/quality_assurance/regulatory_standards/en/index.html
Régions:	Global

Titre:	Guidance on Variations to a Prequalified Product Dossier. WHO Technical Report Series, No. 943, 2007 Annex 6
Sujets:	Quality and Safety: Medicines > Quality Assurance Prequalification of Medicines > WHO-UNICEF-UN Project
An:	2007 Pages: 50
Éditeurs:	WHO Headquarters in Geneva
Régions:	Global

Titre:	Guide to Good Storage Practices for Pharmaceuticals. WHO Technical Report Series, No. 908, 2003, Annex 9
Sujets:	Medicine Access and Rational Use > Supply Management Quality and Safety: Medicines > Quality Assurance
An:	2003 Pages: 12
Éditeurs:	WHO Headquarters in Geneva
Régions:	Global

Titre:	Guidelines for Registration of Fixed-dose Combination Medicinal Products. WHO Technical Report Series, No. 929, 2005, Annex 5
Sujets:	Quality and Safety: Medicines > Quality Assurance Quality and Safety: Medicines > Regulatory Support Prequalification of Medicines > WHO-UNICEF-UN Project
An:	2005 Pages: 49
Éditeurs:	WHO Headquarters in Geneva
Régions:	Global

Titre:	Guidelines for the Preparation of a Procurement Agency Information File. WHO Technical Report Series, No. 917, 2003, Annex 7
Sujets:	Quality and Safety: Medicines > Quality Assurance Quality and Safety: Medicines > Regulatory Support Prequalification of Medicines > WHO-UNICEF-UN Project
An:	2003 Pages: 4
Éditeurs:	WHO Headquarters in Geneva
Régions:	Global

Titre:	Guidelines on Active Pharmaceutical Ingredient Master File Procedure. WHO Technical Report Series, No. 948, 2008, Annex 4
Sujets:	Quality and Safety: Medicines > Quality Assurance Prequalification of Medicines > WHO-UNICEF-UN Project
An:	2008 Pages: 10
Éditeurs:	WHO Headquarters in Geneva
Documents similaires:	Guidelines on Submission of Documentation for a Multisource (Generic) Finished Pharmaceutical Product for the WHO Prequalification of Medicines Programme: Quality Part. WHO Technical Report Series, No. 970, 2012, Annex 4
Régions:	Global

Titre:	Guidelines on Evaluation of Similar Biotherapeutic Products (SBPs). WHO Expert Committee on Biological Standardization, 19-23 October 2009 [Portuguese] [Spanish]
Sujets:	Quality and Safety: Medicines > Blood Products and Related Biologicals Quality and Safety: Medicines > Quality Assurance
An:	2009 Pages: 34
Éditeurs:	WHO Headquarters in Geneva
Régions:	Global

Titre:	Guidelines on Good Manufacturing Practices for Radiopharmaceutical Products. WHO Technical Report Series, No. 908, 2003, Annex 3
Sujets:	Quality and Safety: Medicines > Quality Assurance
An:	2003 Pages: 10
Éditeurs:	WHO Headquarters in Geneva
Documents similaires:	WHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 908 - Thirty-seventh Report
Liens associés:	http://www.who.int/medicines/areas/quality_safety/quality_assurance/production/en/index.html
Régions:	Global

Titre:	Guidelines on Packaging for Pharmaceutical Products. WHO Technical Report Series, No. 902, 2002, Annex 9
Sujets:	Quality and Safety: Medicines > Quality Assurance
An:	2002 Pages: 38
Éditeurs:	WHO Headquarters in Geneva
Liens associés:	http://www.who.int/medicines/areas/quality_safety/quality_assurance/regulatory_standards/en/index.html
Régions:	Global

Titre:	Guidelines on Submission of Documentation for a Multisource (Generic) Finished Pharmaceutical Product for the WHO Prequalification of Medicines Programme: Quality Part. WHO Technical Report Series, No. 970, 2012, Annex 4
Sujets:	Quality and Safety: Medicines > Quality Assurance Prequalification of Medicines > WHO-UNICEF-UN Project
An:	2012 Pages: 76
Éditeurs:	WHO Headquarters in Geneva
Documents similaires:	Pharmaceutical Development of Multisource (Generic) Finished Pharmaceutical Products – Points to Consider. WHO Technical Report Series, No. 970, 2012, Annex 3 Guidelines on Submission of Documentation for a Multisource (Generic) Finished Product. General Format: Preparation of Product Dossiers in Common Technical Document Format. WHO Technical Report Series, No. 961, 2011, Annex 15 Guidelines on Submission of Documentation for Prequalification of Innovator Finished Pharmaceutical Products Approved by Stringent Regulatory Authorities. WHO Technical Report Series, No. 961, 2011, Annex 11 Guidelines on Active Pharmaceutical Ingredient Master File Procedure. WHO Technical Report Series, No. 948, 2008, Annex 4
Régions:	Global

Titre:	Guidelines on Submission of Documentation for a Multisource (Generic) Finished Product. General Format: Preparation of Product Dossiers in Common Technical Document Format. WHO Technical Report Series, No. 961, 2011, Annex 15
Sujets:	Quality and Safety: Medicines > Quality Assurance Prequalification of Medicines > WHO-UNICEF-UN Project
An:	2011 Pages: 12
Éditeurs:	WHO Headquarters in Geneva
Documents similaires:	Guidelines on Submission of Documentation for a Multisource (Generic) Finished Pharmaceutical Product for the WHO Prequalification of Medicines Programme: Quality Part. WHO Technical Report Series, No. 970, 2012, Annex 4 Guidelines on Submission of Documentation for Prequalification of Innovator Finished Pharmaceutical Products Approved by Stringent Regulatory Authorities. WHO Technical Report Series, No. 961, 2011, Annex 11
Régions:	Global

Titre:	Guidelines on Submission of Documentation for Prequalification of Innovator Finished Pharmaceutical Products Approved by Stringent Regulatory Authorities. WHO Technical Report Series, No. 961, 2011, Annex 11
Sujets:	Quality and Safety: Medicines > Quality Assurance Prequalification of Medicines > WHO-UNICEF-UN Project
An:	2011 Pages: 2
Éditeurs:	WHO Headquarters in Geneva
Documents similaires:	Guidelines on Submission of Documentation for a Multisource (Generic) Finished Pharmaceutical Product for the WHO Prequalification of Medicines Programme: Quality Part. WHO Technical Report Series, No. 970, 2012, Annex 4 Guidelines on Submission of Documentation for a Multisource (Generic) Finished Product. General Format: Preparation of Product Dossiers in Common Technical Document Format. WHO Technical Report Series, No. 961, 2011, Annex 15
Régions:	Global

Titre:	Guiding Principles to Ensure Injection Device Security
Sujets:	Quality and Safety: Medicines > Quality Assurance Quality and Safety: Medicines > Safety and Efficacy
An:	2003 Pages: 2
Éditeurs:	WHO Headquarters in Geneva

Titre:	Handbook: Good Laboratory Practice (GLP). Quality Practices for Regulated Non-clinical Research and Development - 2nd Ed.
Sujets:	Quality and Safety: Medicines > Quality Assurance Prequalification of Medicines > WHO-UNICEF-UN Project
An:	2009 Pages: 328
Éditeurs:	WHO/TDR - World Health Organization Special Programme for Research and Training in Tropical Diseases WHO Headquarters in Geneva The World Bank (WB) United Nations Children's Fund (UNICEF) United Nations Development Programme (UNDP)
Documents similaires:	Handbook: Non-Clinical Safety Testing
Régions:	Global

Titre:	Improving Quality for Better Treatment and Greater Access
Sujets:	Medicine Access and Rational Use > Pricing Quality and Safety: Medicines > Quality Assurance Quality and Safety: Medicines > Regulatory Support Prequalification of Medicines > WHO-UNICEF-UN Project
An:	2012 Pages: 7
Éditeurs:	WHO Headquarters in Geneva
Régions:	Global

Titre:	Inspection of API Manufacturing Sites
Sujets:	Quality and Safety: Medicines > Quality Assurance Prequalification of Medicines > WHO-UNICEF-UN Project
An:	2011 Pages: 4
Éditeurs:	WHO Headquarters in Geneva
Régions:	Global

Titre:	Joint FIP/WHO Guidelines on Good Pharmacy Practice: Standards for Quality of Pharmacy Services. WHO Technical Report Series, No. 961, 2011, Annex 8
Sujets:	Quality and Safety: Medicines > Quality Assurance Quality and Safety: Medicines > Safety and Efficacy
An:	2011 Pages: 14
Éditeurs:	WHO Headquarters in Geneva
Régions:	Global

Titre:	Malaria Microscopy Quality Assurance Manual. Version 1
Sujets:	Quality and Safety: Medicines > Quality Assurance
An:	2009 Pages: 149
Éditeurs:	WHO Headquarters in Geneva
Régions:	Global

Titre:	Mechanism to Combat Substandard/Spurious/Falsely-labelled/ Falsified/Counterfeit Medical Products (WHO Drug Information, Vol 27, No. 1, 2013)
Sujets:	Medicine Information and Evidence for Policy > Information and Publications Quality and Safety: Medicines > Counterfeit Medicines Quality and Safety: Medicines > Quality Assurance Prequalification of Medicines > WHO-UNICEF-UN Project
An:	2013 Pages: 2
Éditeurs:	WHO Headquarters in Geneva
Documents similaires:	WHO Drug Information Vol. 27, No. 1, 2013 - Recommended International Nonproprietary Names, List 69
Régions:	Global; Afrique (AFRO)

Titre:	Model Certificate of Analysis. WHO Technical Report Series, No. 902, 2002, Annex 10
Sujets:	Quality and Safety: Medicines > Quality Assurance
An:	2002 Pages: 4
Éditeurs:	WHO Headquarters in Geneva
Documents similaires:	Considerations for Requesting Analysis of Drug Samples. WHO Technical Report Series, No. 902, 2002, Annex 4
Régions:	Global

Titre:	Model Certificate of Good Manufacturing Practices. WHO Technical Report Series, No. 908, 2003, Annex 5
Sujets:	Quality and Safety: Medicines > Quality Assurance
An:	2003 Pages: 4
Éditeurs:	WHO Headquarters in Geneva
Liens associés:	http://www.who.int/medicines/areas/quality_safety/quality_assurance/inspections/en/index.html
Régions:	Global

Titre:	Model Guidance for the Storage and Transport of Time and Temperature-sensitive Pharmaceutical Products. WHO Technical Report Series, No.961, 2011, Annex 9
Sujets:	Quality and Safety: Medicines > Blood Products and Related Biologicals Quality and Safety: Medicines > Quality Assurance
An:	2011 Pages: 49
Éditeurs:	WHO Headquarters in Geneva
Liens associés:	http://www.who.int/medicines/areas/quality_safety/quality_assurance/distribution/en/index.html
Régions:	Global

Titre:	A Model Quality Assurance System for Procurement Agencies - Recommendations for Quality Assurance Systems Focusing on Prequalification of Products and Manufacturers, Purchasing, Storage and Distribution of Pharmaceutical Products [French]
Sujets:	Medicine Access and Rational Use > Supply Management Quality and Safety: Medicines > Quality Assurance Prequalification of Medicines > WHO-UNICEF-UN Project
An:	2007 Pages: 140
Éditeurs:	WHO Headquarters in Geneva
Régions:	Global

Titre:	Multisource (Generic) Pharmaceutical Products: Guidelines on Registration Requirements to Establish Interchangeability. WHO Technical Report Series, No. 937, 2006, Annex 7
Sujets:	Quality and Safety: Medicines > Quality Assurance Quality and Safety: Medicines > Regulatory Support
An:	2006 Pages: 44
Éditeurs:	WHO Headquarters in Geneva
Liens associés:	http://www.who.int/medicines/areas/quality_safety/quality_assurance/regulatory_standards/en/index.html
Régions:	Global

Titre:	Pharmaceutical Development of Multisource (Generic) Finished Pharmaceutical Products – Points to Consider. WHO Technical Report Series, No. 970, 2012, Annex 3
Sujets:	Quality and Safety: Medicines > Quality Assurance Prequalification of Medicines > WHO-UNICEF-UN Project
An:	2012 Pages: 29
Éditeurs:	WHO Headquarters in Geneva
Documents similaires:	Guidelines on Submission of Documentation for a Multisource (Generic) Finished Pharmaceutical Product for the WHO Prequalification of Medicines Programme: Quality Part. WHO Technical Report Series, No. 970, 2012, Annex 4
Régions:	Global

Titre:	Prequalification of Quality Control Laboratories. Procedure for Assessing the Acceptability, in Principle, of Quality Control Laboratories for Use by United Nations Agencies. WHO Technical Report Series, No. 961, 2011, Annex 12 [French]
Sujets:	Quality and Safety: Medicines > Quality Assurance Prequalification of Medicines > WHO-UNICEF-UN Project
An:	2011 Pages: 10
Éditeurs:	WHO Headquarters in Geneva
Régions:	Global

Titre:	Procedure for Assessing the Acceptability, in Principle, of Procurement Agencies for Use by United Nations Agencies. WHO Technical Report Series, No. 917, 2003, Annex 6
Sujets:	Medicine Access and Rational Use > Supply Management Quality and Safety: Medicines > Quality Assurance
An:	2003 Pages: 10
Éditeurs:	WHO Headquarters in Geneva
Documents similaires:	WHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 917 - Thirty-eighth Report
Liens associés:	http://www.who.int/medicines/areas/quality_safety/quality_assurance/distribution/en/index.html
Régions:	Global


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Dernière mise à jour: le 3 mai 2013