Search results - 8 results
The consistency approach for the substitution of in vivo testing for the quality control of established vaccines: practical considerations and progressive vision
Regulatory Health Topics: Vaccine batch conformity Vaccin lot conformiteit Conformité de lot de vaccin Service: Qualité des vaccins et produits sanguins Kwaliteit van vaccins en bloedproducten Quality of ...
Quality Control of Polysaccharide Vaccines by the Belgian National Control Lab (OMCL) in the European Batch Release Framework: Activity Report 2016
vaccins et produits sanguins Kwaliteit van vaccins en bloedproducten Quality of vaccines and blood products Manuscript versions: File: Version: Published Full text access: Public Access Full text ...
Batch release of vaccines in Europe: from method transfer to first commercial batch available on the market. Straightforward approach that requires a proactive mind-set of the manufacturer.
medicinal products or medicinal products derived from human blood or plasma by an Official Medicines Control Laboratory (OMCL) before these can be marketed. The competent authorities issue a Batch Release ...
The Biological Standardisation activities at the international level
Publication Type: Scientific poster, presentation or proceeding Authors: Wim Van Molle Source: Quality control and batch release of vaccines and blood products in Europe, WIV-ISP, Issue WIV-ISP, ...
Quality Control of polysaccharide Vaccines by the Belgian National Control Lab (OMCL) in the European Batch Release Framework: Activity Report 2014
sanguins Kwaliteit van vaccins en bloedproducten Quality of vaccines and blood products Manuscript versions: File: Version: Published Full text access: Public Access Full text language: English ...
Quality Control of Polysaccharide Vaccines by the Belgian National Control Lab (OMCL) in the European Batch Release Framework: Activity Report 2013
Publication Type: Sci. report, recommendat°, guidance doc., directive, monograph Authors: L. Tesolin; Wim Van Molle Source: Scientific Institute of Public Health, Brussels, Belgium, p.74 (2014) ISBN: D/2014/2505/42 Accession Number: D/2014/2505/42 Keyword ...
Quality control of polysaccharide vaccines by the Belgian National Control Lab (OMCL) in the European batch release framework: activity report 2012.
(2013) ISBN: D/2013/2505/36 Accession Number: D/2013/2505/36 Keywords: 2012 Activity batch release Belgian Control European national Quality Quality Control report vaccine vaccines Health Topics: Vaccine ...
Implementation over the past 20 years of the 3R's principle for batch release at the Scientific Institute of Public Health, Belgium (IPH).
Publication Type: Scientific poster, presentation or proceeding Authors: Wim Van Molle; A. Maes; F Ribaucour; Geneviève Waeterloos Source: Quality of medicines in a globalised world: dreams and ...