Zoekresultaten - 9 results
WHO Guidelines on Post Approval Changes- Appendix 1 Reporting categories and suggested review timelines
Publication Type: Scientific poster, presentation or proceeding Authors: Tesolin, L. Source: Workshop on management of post approval changes, 03-05/12/2024, Hanoi-Viet Nam, WHO, Hanoi, Viet Nam ...
WHO Guidelines on Post approval Changes- Appendix 2+3 Reporting procedures and data requirements for quality changes to antigens + finished products
Publication Type: Scientific poster, presentation or proceeding Authors: Tesolin, L. Source: Workshop on management of post approval changes, 03-05/12/2024, Hanoi-Viet Nam, WHO, Hanoi, Viet Nam ...
Best practices for lot release of mRNA vaccines
Publication Type: Scientific poster, presentation or proceeding Authors: Geneviève Waeterloos; N. Desmet; L. Stradiot Source: WHO-Network of National control laboratories for Biologicals- 6th ...
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 ...
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 ...
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 Innovation (CBI), Issue MIT Center for Biomedical Innovation (C ...
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, ...
Batch release of vaccines in Europe: from method transfer to first commercial batch available on the market. Straightforward approach that requires a proactive mind-set of the manufacturer.
Publication Type: Scientific poster, presentation or proceeding Authors: Wim Van Molle; L. Tesolin; Koen Brusselmans; Geneviève Waeterloos Source: PDA Europe Conference Vaccines. Featuring WHO on ...