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91 documents en 2 pages
 
 
 
 
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Establishment of Public Health laboratories in South East Asia Region. New Delhi: World Health Organization, Regional Office for South-East Asia; 2018

An:

2018;

Pages:

150;


 
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Global Vaccine Safety Blueprint 2.0 Background Research. Geneva: World Health Organization; 2019

An:

2019;

Pages:

42;


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Global Vaccine Safety Blueprint. Geneva: World Health Organization; 2012

An:

2012;

Pages:

50;


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Global Vaccine Safety Initiative. Report of a meeting, Kuala, Lumpur, Malaysia, 11-12 October 2017

An:

2018;

Pages:

108;


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Global Vaccine Safety Initiative. Report of a meeting, Santiago, Chile, 8-9 October 2018. Geneva: World Health Organization; 2019

An:

2019;

Pages:

89;


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Guidelines for the Production, Control and Regulation of Snake Antivenom Immunoglobulins. Replacement of Annex 2 of WHO Technical Report Series, No. 964. WHO Expert Committee on Biological Standardization, Sixty-seventh Report; WHO Technical Report Series No. 1004, 2017, Annex 5

An:

2017;

Pages:

192;


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Guidelines on procedures and data requirements for changes to approved biotherapeutic products. WHO Expert Committee on Biological Standardization, Sixty-eighth Report; WHO Technical Report Series No. 1011, 2018, Annex 3

An:

2018;

Pages:

99;


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Post-Market Surveillance – How to Detect Problems for HIV Self-Testing Test Kits

An:

2018;

Pages:

2;


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Regulatory Evaluation of Biosimilars Throughout Their Product Life-cycle. (Bull World Health Organ 2018;96:281–285)

An:

2018;

Pages:

5;


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Selection and Use of Ebola in Vitro Diagnostic (Ivd) Assays. Emergency Guidance. June 2015

An:

2015;

Pages:

9;


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Stakeholders Meeting on Maternal Interventions Vigilance: Safety Monitoring and Surveillance in Vaccine and other Research Settings. Report of a meeting, Geneva, Switzerland, 20-21 November 2017

An:

2018;

Pages:

45;


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Technical Guidance Series 1 (TGS–1) for WHO Prequalification of in Vitro Diagnostic Medical Devices: Standards Applicable to the WHO Prequalification of in Vitro Diagnostic Medical Devices

An:

2017;

Pages:

33;


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Technical Guidance Series 2 (Annex to TGS–2) for WHO Prequalification – Diagnostic Assessment: Establishing Component Stability of In Vitro Diagnostic Medical Devices

An:

2019;

Pages:

24;


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Technical Guidance Series 2 (TGS–2) for WHO Prequalification – Diagnostic Assessment: Establishing stability of in vitro diagnostic medical devices. WHO Expert Committee on Biological Standardization, Sixty-eighth Report; WHO Technical Report Series No. 1011, 2018, Annex 5

An:

2018;

Pages:

61;


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Technical Guidance Series 3 (TGS–3) for WHO Prequalification – Diagnostic Assessment: Principles of Performance Studies

An:

2017;

Pages:

29;


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Technical Guidance Series 4 (TGS–4) for WHO Prequalification – Diagnostic Assessment: Guidance on Test Method Validation for in Vitro Diagnostic Medical Devices

An:

2017;

Pages:

26;


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Technical Guidance Series 5 (TGS–5) for WHO Prequalification – Diagnostic Assessment: Designing Instructions for Use for in Vitro Diagnostic Medical Devices

An:

2017;

Pages:

37;


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Technical Specifications Series 1 (TSS–1) for Submission to WHO Prequalification – Diagnostic Assessment: Human Immunodeficiency Virus (HIV) Rapid Diagnostic Tests for Professional Use And/Or Self-testing

An:

2018;

Pages:

26;


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Technical Specifications Series 1 (TSS–1) for WHO Prequalification – Diagnostic Assessment: Human immunodeficiency virus (HIV) rapid diagnostic tests for professional use and/or self-testing. WHO Expert Committee on Biological Standardization, Sixty-eighth Report; WHO Technical Report Series No. 1011, 2018, Annex 4

An:

2018;

Pages:

34;


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Technical Specifications Series 2 (TSS–2) for Submission to WHO Prequalification – Diagnostic Assessment: In Vitro Diagnostic Medical Devices to Identify Glucose-6-phosphate Dehydrogenase (G6PD) Activity

An:

2016;

Pages:

22;


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