Publications and links
A large number of publications on diverse topics is produced by the biological standardization program of WHO. These include:
- Written reports of the proceedings and conclusions of consultations and other meetings are available shortly after its conclusion.
- Guidance documents which appear on the WHO Biologicals website prior to being published in the reports of the Expert Committee on Biological Standardization (ECBS) in the Technical Report Series (TRS).
- Biological standardization study reports (BS documents) which serve as the basis for the establishment of physical reference materials by the Expert Committee (ECBS) are published.
The rapid appearance of such documents in electronic form conform with WHO's policy of impartial and evidence-based decision making. The documents posted on this site represent however only a part of the total work of WHO in the quality control and utilization medicines, and additional information can be obtained in the home pages of the contributing areas. Paper copies of many of these documents are also available for purchase from the document centers listed in the links section below.
Links to meeting reports, the Technical Report Series, and the reference preparations are provided on individual topic pages. These can be found by using the navigational tabs on the left side of each page of this site.
Paper copies of a selected number of publications may be purchased from WHO:
- Similar Biotherapeutic Products: Biologicals Special Edition, September 2011. To see all 26 articles, please click here:
- WHO manual for the establishment of national and other secondary standards for vaccines
WHO/KFDA Joint workshop on implementing WHO guidelines on evaluating similar biotherapeutic products, Seoul, Republic of Korea, 24-26 August 2010
Outcomes of the Expert Committee on Biological Standardization 18-22 October 2010
Recommendations for the Evaluation of Animal Cell Cultures as substrates for the manufacture of biological medicinal products and for the characterization of Cell Banks
Recommendations to assure the Quality, Safety and Efficacy of recombinant Hepatitis B Vaccines
Guidelines for Independent Lot Release of Vaccines by Regulatory Authorities
Recommendations to assure the Quality, Safety and Efficacy of Live attentuated Yellow Fever Vaccines
WHO HPV LabNet - Newsletter No. 8
WHO HPV LabNet Training Workshop on HPV Genotyping and HPV Serology Laboratory Performance, 15-18 March 2010
WHO Working Group Meeting to discuss the revision of the WHO Recommendations for OPV: TRS 904 and 910, 20-22 July 2010
WHO Informal Consultation on Standardization and Evaluation of BCG Vaccines, 22-23 September 2009
Guidelines on evaluation of Similar Biotherapeutic Products (SBPs), ECBS 19-23 October 2009
- WHO Informal Consultation on Regulatory considerations for evaluation of Ebola Vaccines intended for emergency use, WHO/HQ Geneva, Switzerland, 18-19 March 2015
- WHO Informal Consultation on Stability Evaluation of Vaccines for use in a Controlled Temperature Chain, WHO/HQ Geneva, Switzerland, 24–26 March 2015
- WHO Informal Consultation on Amendment for Similar Biotherapeutic products of monoclonal antibodies, WHO/HQ Geneva, Switzerland, 27–28 April 2015
- WHO Informal Consultation on Regulatory risk assessment for biotherapeutic products, WHO/HQ Geneva, Switzerland, 29–30 April 2015
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