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252 documents en 6 pages
 
 
 
 
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18th International Conference of Drug Regulatory Authorities (ICDRA). “Smart Safety surveillance: A life-cycle approach to promoting safety of medical products”. (WHO Drug Information Vol. 32, No. 4, 2018)

An:

2019;

Pages:

10;


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70 Years of WHO Standards on Medicines Quality Expert Committee on Specifications for Pharmaceutical Preparations, 1947-2017: Addressing Changing Public Health Challenges. (WHO Drug Information Vol. 31, No. 1, 2017)

An:

2017;

Pages:

12;


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Addressing the Barriers to Effective Monitoring, Reporting and Containment of Spurious/Substandard/Falsely-labelled/ Falsified/Counterfeit Medical Products through Sustainable Multi-stakeholder Collaboration and Community/Consumer-based Interventions. A report prepared for the Medicines Transparency Alliance, Philippines

An:

2016;

Pages:

94;


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An Assessment of Global Chemistry, Manufacturing and Controls (CMC) Regulatory Requirements in Low and Middle Income Countries. (WHO Drug Information Vol. 32, No. 3, 2018)

An:

2018;

Pages:

7;


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Assuring Medicines Quality in Medicines Procurement. May 21, 2019

An:

2019;

Pages:

8;


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Boas Práticas da OMS para Laboratórios de Controle de Qualidade de Produtos Farmacêuticos (Série de Relatórios Tecnicos da OMS, No. 957, 2010 - Relatório 44, Anexo 1) e Documento de Auto-Avaliação de Boas Práticas de Laboratório (BPL) - Rede PARF Documento Técnico No. 9 (Rede Pan-Americana da Harmonização de Regulamentação Farmacêutica) [English] [French] [Spanish] [Thai]

An:

2011;

Pages:

58;


 
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Boas práticas da OMS para laboratórios de microbiologia farmacêutica - Rede PARF Documento Técnico Nº 11 (Rede Pan-Americana da Harmonização de Regulamentação Farmacêutica) [English]

An:

2012;

Pages:

37;


 
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Collaboration, Not Competition: Developing New Reliance Models - Regulatory Collaboration. Exchange of Assessment Reports (ARs) with Regulators Outside the European Union (EU). (WHO Drug Information Vol. 30, No. 4, 2016)

An:

2017;

Pages:

9;


 
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Collaborative Procedure Between the World Health Organization (WHO) Prequalification Team and National Regulatory Authorities in the Assessment and Accelerated National Registration of WHO-prequalified Pharmaceutical Products and Vaccines. WHO Technical Report Series, No. 996, 2016, Annex 8

An:

2016;

Pages:

42;


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Collaborative Procedure in the Assessment and Accelerated National Registration of Pharmaceutical Products and Vaccines Approved by Stringent Regulatory Authorities. WHO Technical Report Series, No. 1010, 2018, Annex 11

An:

2018;

Pages:

54;


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Concept paper for discussion: A stepwise approach for pharmaceutical companies in developing countries to attain WHO GMP standards. (WHO Drug Information Vol. 30, No. 2, 2016)

An:

2016;

Pages:

13;


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Considerations for Requesting Analysis of Medicines Samples. WHO Technical Report Series, No. 1010, 2018, Annex 3

An:

2018;

Pages:

8;


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Documento de Autoevaluación de Buenas Prácticas de Laboratorio (BPL) / Documento de Auto-Avaliação de Boas Práticas de Laboratório (BPL) / Document on Self-Evaluation of Good Laboratory Practices (GLP) - Red PARF Documento Técnico No. 6 (Red Panamericana de Armonización de la Reglamentación Farmacéutica)

An:

2011;

Pages:

113;


 
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Emergency Use Assessment and Listing Procedure (EUAL) for Candidate in Vitro Diagnostics (IVDs) for Use in the Context of a Public Health Emergency

An:

2015;

Pages:

11;


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Emergency Use Assessment and Listing Procedure (EUAL) for Candidate Medicines for Use in the Context of a Public Health Emergency

An:

2015;

Pages:

9;


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Emergency Use Assessment and Listing Procedure (EUAL) for Candidate Vaccines for Use in the Context of a Public Health Emergency

An:

2015;

Pages:

10;


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Estudio sobre las Condiciones Actuales de los Laboratorios Oficiales de Control de Calidad de Medicamentos (LOCM) en América Latina y el Caribe / World Health Organization (WHO) Study of the Current Conditions of the Official Medicine Control Laboratories (OMCL) in Latin America and the Caribbean / Estudo sobre as Condições Atuais dos Laboratórios Oficiais de Controle da Qualidade de Medicamentos (LOCM) na América Latina e Caribe Farmacêutico - Red PARF Documento Técnico No. 4 (Red Panamericana de Armonización de la Reglamentación Farmacéutica)

An:

2010;

Pages:

45;


 
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First General Meeting of the WHO-National Control Laboratory Network for Biologicals (WHO-NNB). Noida, India, 31 October – 2 November 2017

An:

2017;

Pages:

15;


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General Background Notes on the List of International Comparator Pharmaceutical Products. WHO Technical Report Series, No. 1003, 2017, Annex 5

An:

2017;

Pages:

2;


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Global Access to Hepatitis Drugs and Diagnostics Consultation with Pharmaceutical and Diagnostics Companies. 16 June 2014, Geneva, Switzerland

An:

2014;

Pages:

24;


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Global Network of National Vaccine Control Laboratories. (WHO Drug Information Vol. 31, No. 1, 2017)

An:

2017;

Pages:

8;


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Good Practices of National Regulatory Authorities in Implementing the Collaborative Registration Procedures for Medical Products. WHO Technical Report Series, No. 1019, 2019, Annex 6

An:

2019;

Pages:

53;


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Guidance on Good Manufacturing Practices: Inspection Report. (Including Appendix 1: Guidance on Good Manufacturing Practices: Inspection Report; Appendix 2: Example of a Risk Category Assessment of the Site Depending on Level of Compliance and Inspection Frequency. WHO Technical Report Series, No. 996, 2016, Annex 4

An:

2016;

Pages:

16;


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Le Portail d'information - Médicaments essentiels et produits de santé a été conçu et est maintenu par l'ONG Human Info. Dernière mise à jour: le 1 décembre 2019