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