Zoekresultaten - 28 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

Publication Type: Peer reviewed scientific article Authors: L. Tesolin; J.-F. Dierick; Wim Van Molle Source: Open Research Europe (2022) Keywords: human vaccines in vitro testing in vivo testing ...

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 ...

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