Zoekresultaten - 26 results

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

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 ...

Report of WHO Drafting Group meeting to revise WHO Guidelines on procedures and data requirements for changes to approved vaccines

(2023) 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 ...

OCABR: Respiratory Syncytial Virus (rDNA) Vaccine

vaccins et produits sanguins Kwaliteit van vaccins en bloedproducten Quality of vaccines and blood products Manuscript versions:  DOI:  http://x Full text access:  Restricted Access Full text language:  ...

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

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 sciences ...

The consistency approach for the substitution of in vivo testing for the quality control of established vaccines: practical considerations and progressive vision

Regulatory 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 ...

Method transfer of the hexavalent vaccine Vaxelis: a bumpy road with a happy ending

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 vaccines and blood ...

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.

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 ...

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