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
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
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
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.
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 ...