Résultats de la recherche - 10 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
(2017) Keywords: Vaccine conformity Health Topics: Vaccine batch conformity Vaccin lot conformiteit Conformité de lot de vaccin Service: Qualité des vaccins et produits sanguins Kwaliteit van vaccins en ...
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.
Publication Type: Scientific poster, presentation or proceeding Authors: Wim Van Molle Source: 2017 Vaccines Bioprocess Development & Commercialization Workshop, MIT Center for Biomedical ...
Panel discussion on CMC for vaccines: "Responding in Time: Dealing with Predictable and Unpredictable"
Publication Type: Scientific poster, presentation or proceeding Authors: Wim Van Molle Source: 2017 Vaccines Bioprocess Development & Commercialization Workshop, MIT Center for Biomedical ...
Setting specifications for Biologicals. Points to consider from simple to complex. Case study for viral vectored vaccines.
Cambridge, MA, USA (2017) Keywords: vaccine Health Topics: Vaccine batch conformity Vaccin lot conformiteit Conformité de lot de vaccin Service: Qualité des vaccins et produits sanguins Kwaliteit van vaccins ...
Panel discussion on specifications for biologicals
Cambridge, MA, USA (2017) Keywords: vaccine Health Topics: Vaccine batch conformity Vaccin lot conformiteit Conformité de lot de vaccin Service: Qualité des vaccins et produits sanguins Kwaliteit van vaccins ...
Quality Control of Polysaccharide Vaccines by the Belgian National Control Lab (OMCL) in the European Batch Release Framework: Activity Report 2016
ISBN: D/2017/2505/44 Accession Number: D/2017/2505/44 Keywords: Vaccine conformity Health Topics: Vaccine batch conformity Vaccin lot conformiteit Conformité de lot de vaccin Service: Qualité des ...
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.
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 ...