Résultats de la recherche - 20 results

Training on the assessment of quality part (M3) of the eCTD for the registration of vaccines for human use

registration of vaccines for human use, Sciensano, Brussels, Belgium (2023) Keywords: assessment module 3 vaccines Health Topics:  Vaccine batch conformity Vaccin lot conformiteit Conformité de lot de vaccin ...

WHO Drafting Group meeting to revise WHO Guidelines on PAC- outcome of workshops

approved vaccines, WHO, Frankfurt, Germany (2023) Keywords: post-approval changes vaccines WHO Health Topics:  Vaccine batch conformity Vaccin lot conformiteit Conformité de lot de vaccin Service:  Qualité ...

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 ...

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