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Zoekresultaten - 28 results

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

Publication Type: Scientific poster, presentation or proceeding Authors: Koen Brusselmans; Wim Van Molle; L. Tesolin Source: Training on The assessment of quality part (M3) of the eCTD for the registration of vaccines for human use, Sciensano, Brussels, B ...

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

Publication Type: Sci. report, recommendat°, guidance doc., directive, monograph Authors: L. Tesolin; H. Meyer; D. Lei; T. Jivapaisarnpong; M. Welin; A. Cheung Source: WHO, Geneva, switzerland, p.9 (2023) Health Topics:  Vaccine batch conformity Vaccin lo ...

OCABR: Respiratory Syncytial Virus (rDNA) Vaccine

Publication Type: Sci. report, recommendat°, guidance doc., directive, monograph Authors: L. Tesolin; D. Garcia; V. Oppling; M. Bruysters; D. Pullirsch; L. Campitelli Source: EDQM, Strasbourg (F), p.15 (2023) Accession Number: PA/PH/OMCL (23) 3 DEF Keywor ...

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

Publication Type: Scientific poster, presentation or proceeding Authors: L. Tesolin Source: WHO Drafting Group meeting to revise WHO Guidelines on procedures and data requirements for changes to approved vaccines, WHO, Frankfurt, Germany (2023) Keywords: ...

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 Regulatory Health Topics:  Vaccine batch conformity Vaccin l ...

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 Topics:  Vaccine batch conformity Vaccin lot conformiteit Co ...

The Role of EDQM and OMCLs

Publication Type: Scientific poster, presentation or proceeding Authors: Wim Van Molle Source: Training « Responsable des affaires réglementaires ", In Vivo, Issue In Vivo, Nivelles, Belgium (2017) Keywords: Vaccine conformity Health Topics:  Vaccine ...

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, Greece (2017) Keywords: vaccine Health Topics:  Vaccine b ...

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 Innovation (CBI), Issue MIT Center for Biomedical Innovation (C ...

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 Innovation (CBI), Issue MIT Center for Biomedical Innovation (C ...

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