Zoekresultaten - 12 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
Greece (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 en ...
Appoaching EMA and National regulatory authorties: who, when and how.
Innovation (CBI), Issue MIT Center for Biomedical Innovation (CBI), Cambrige, MA, USA (2017) Keywords: vaccine Health Topics: Vaccine batch conformity Vaccin lot conformiteit Conformité de lot de vaccin ...
Panel discussion on CMC for vaccines: "Responding in Time: Dealing with Predictable and Unpredictable"
Innovation (CBI), Issue MIT Center for Biomedical Innovation (CBI), Cambrdige, MA, USA (2017) Keywords: vaccine Health Topics: Vaccine batch conformity Vaccin lot conformiteit Conformité de lot de vaccin ...
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 ...
Evaluation of quality and non-clinical data for licencing of vaccines
Greece (2016) 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 en ...
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.
out-of-stock situations. 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 ...
Testing of expired Synflorix bulks: actions taken by three OMCLs and concerns raised by another OMCL.
Health Topics: Vaccine batch conformity Vaccin lot conformiteit Conformité de lot de vaccin Efficacité et sécurité des vaccins, médicaments et produits de santé- Qualité des laboratoires médicaux ...