Résultats de la recherche - 15 results
Method transfer of the hexavalent vaccine Vaxelis: a bumpy road with a happy ending
Publication Type: Scientific poster, presentation or proceeding Authors: Wim Van Molle Source: OMCL Annual Meeting, EDQM, Issue EDQM, Budapest, Hungary (2017) Keywords: Vaccine conformity Health ...
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) ...
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, ...
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.
validation process from start to finish can take up to 2 years, especially for complex and/or multivalent vaccines. The OMCL s also operate under a quality assurance system according to ISO17025 norm. At all ...