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Zoekresultaten - 30 results
Advanced Analysis of Biopharmaceuticals: Endotoxin content & Sterility testing
Publication Type: Scientific poster, presentation or proceeding Authors: Tesolin, L. Source: African Medicines Regulatory Harmonization (AMRH) 5th Continental GMP Training Workshop: A focus on ...
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 ...
The batch release procedure in Europe
Publication Type: Scientific poster, presentation or proceeding Authors: Tesolin, L. Source: Seminaire etudiants en pharmacie ULB, Sciensano, ULB Brussels (2024) Keywords: batch release vaccine ...
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 ...
Animal use reporting: 2019-2023
Publication Type: Scientific poster, presentation or proceeding Authors: Geneviève Waeterloos; F Ribaucour Source: OCABR Advisory group meeting, EDQM, Issue EDQM, Strasbourg, France (0) URL: ...
regulatory roadmap for 3D mucosal model development, an overview
Publication Type: Scientific poster, presentation or proceeding Authors: Tesolin, L. Source: ECR Trimestrial meeting Inno4vac, virtual, IHI, virtual (2024) Keywords: 3D mucosal model development ...
Animal use reporting: 2019-2022
Publication Type: Scientific poster, presentation or proceeding Authors: Geneviève Waeterloos; F Ribaucour Source: Annual OMCL meeting 2024, Common OCABR vaccine session, EDQM, OMCL network ...
Implementing the 3RS in quality Control and batch release testing- view from a Belgian OMCL
Publication Type: Scientific poster, presentation or proceeding Authors: Florens, M.; Tesolin, L. Source: AFMPS- Advancing the 3Rs for Regulatory Testing of Medicines-31/01/2024-Antwerpen, Belgium, ...
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 ...