Zoekresultaten - 231 results

The Role of EDQM and OMCLs

Publication Type: Scientific poster, presentation or proceeding Authors: Wim Van Molle Source: Training « Responsable des affaires réglementaires ", In Vivo, Issue In Vivo, Nivelles, Belgium ...

Evaluation of quality and non-clinical data for licencing of vaccines

Publication Type: Scientific poster, presentation or proceeding Authors: Wim Van Molle Source: WHO GLO Evaluation of quality and non-clinical data for licensing of vaccines, WHO, Issue WHO, Athens, ...

Appoaching EMA and National regulatory authorties: who, when and how.

Service:  Qualité des vaccins et produits sanguins Kwaliteit van vaccins en bloedproducten Quality of vaccines and blood products Full text language:  English Category:  C31 FOS Classification:  3.03 Health ...

Panel discussion on CMC for vaccines: "Responding in Time: Dealing with Predictable and Unpredictable"

Service:  Qualité des vaccins et produits sanguins Kwaliteit van vaccins en bloedproducten Quality of vaccines and blood products Full text language:  English Category:  C31 FOS Classification:  3.03 Health ...

Setting specifications for Biologicals. Points to consider from simple to complex. Case study for viral vectored vaccines.

Publication Type: Scientific poster, presentation or proceeding Authors: Wim Van Molle Source: 2017 BioMAN Workshop on Setting Specifications for Biotherapeutic Products, BioMAN, Issue BioMAN, ...

Panel discussion on specifications for biologicals

Publication Type: Scientific poster, presentation or proceeding Authors: Wim Van Molle Source: 2017 BioMAN Workshop on Setting Specifications for Biotherapeutic Products, BioMAN, Issue BioMAN, ...

Quality Control of Polysaccharide Vaccines by the Belgian National Control Lab (OMCL) in the European Batch Release Framework: Activity Report 2016

Publication Type: Sci. report, recommendat°, guidance doc., directive, monograph Authors: L. Tesolin; Wim Van Molle Source: Scientific Institute of Public Health, Brussels, Belgium, p.59 (2017) ...

Report on the collaborative study for the standardization of D-Ag potency assays for inactivated polio vaccines made with Sabin live-attenuated poliovirus strains

Publication Type: Sci. report, recommendat°, guidance doc., directive, monograph Authors: J. Martin; A. Daas; C. Milne; Alexandre Dobly Source: EDQM, Strasbourg, p.16 (2016) Accession Number: na ...

European Pharmacopoeia biological reference preparation for poliomyelitis vaccine (inactivated)

Publication Type: Sci. report, recommendat°, guidance doc., directive, monograph Authors: J. Martin; A. Daas; C. Milne; Alexandre Dobly (contributing scientist) Source: EDQM, Volume Pharmeuropa ...

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