Zoekresultaten - 11 results
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.
Publication Type: Scientific poster, presentation or proceeding Authors: Wim Van Molle; L. Tesolin; Koen Brusselmans; Geneviève Waeterloos Source: PDA Europe Conference Vaccines. Featuring WHO on Challenges in Vaccines Supply to Developing Countries, PDA ...
Testing of expired Synflorix bulks: actions taken by three OMCLs and concerns raised by another OMCL.
Publication Type: Scientific poster, presentation or proceeding Authors: Wim Van Molle Source: Annual OMCL meeting, EDQM, Issue EDQM, Brussels, Belgium (2015) Keywords: batch release meeting TESTING Health Topics: Vaccine batch conformity Vaccin lot conf ...
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, Brussels, Belgium (2015) Keywords: Activity at batch release ...
Vaxelis (PR5I): another fully liquid hexavalent vaccine on the EU market in 2016.
Publication Type: Scientific poster, presentation or proceeding Authors: Wim Van Molle Source: Annual OMCL meeting, EDQM, Issue EDQM, Brussels, Belgium (2015) Keywords: EU meeting ON vaccine Health Topics: Vaccine batch conformity Vaccin lot conformiteit ...
Quality control of polysaccharide vaccines by the Belgian National Control Lab (OMCL) in the European batch release framework: activity report 2012.
Publication Type: Sci. report, recommendat°, guidance doc., directive, monograph Authors: L. Tesolin; Wim Van Molle Source: Scientific Institute of Public Health (WIV-ISP), Brussels, Belgium, p.49 (2013) ISBN: D/2013/2505/36 Accession Number: D/2013/2505/ ...
Hexacima: a fully liquid hexavalent vaccine (soon) on the market
Publication Type: Scientific poster, presentation or proceeding Authors: Wim Van Molle Source: Annual OMCL meeting, EDQM, Issue EDQM, Helsinki, Finnland (2013) Keywords: a meeting ON vaccine Health Topics: Vaccine batch conformity Vaccin lot conformiteit ...
Possible presence of particles in MMR vaccines detected by Egyptian OMCL resolved by interaction with Belgian OMCL and manufacture
Publication Type: Scientific poster, presentation or proceeding Authors: Wim Van Molle Source: Annual OMCL Meeting, EDQM, Issue EDQM, Helsinki, Finnland (2013) Keywords: Belgian interaction meeting vaccine vaccines Health Topics: Vaccine batch conformity ...
Release testing by manufacturers & Ph.Eur. compliance: lessons learnt for competent authorities. A case study: the Extractable Volume
Publication Type: Scientific poster, presentation or proceeding Authors: Wim Van Molle; Geneviève Waeterloos Source: Annual OMCL meeting, NA, Issue EDQM, NA (2012) Keywords: a Case case studies Case study case-study compliance meeting Release testing stud ...
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 reality, EDQM, Issue European Directorate for the Quality of ...
Testing and release of Synflorix ® monovalent conjugated bulks: update after 1 year of a complex vaccine with complex testing
Publication Type: Scientific poster, presentation or proceeding Authors: Wim Van Molle Source: Annual OMCL meeting, EDQM, Issue EDQM, Split, Croatia (2010) Keywords: a meeting Release testing TESTING vaccine Health Topics: Vaccine batch conformity Vaccin ...