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Résultats de la recherche - 32 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 ...

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

p.15 (2023) Accession Number: PA/PH/OMCL (23) 3 DEF Keywords: EDQM guideline OCABR RSV Health Topics:  Vaccine batch conformity Vaccin lot conformiteit Conformité de lot de vaccin Service:  Qualité des ...

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 ...

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

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 ...

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