Zoekresultaten - 242 results
Advanced Analysis of Biopharmaceuticals: Endotoxin content & Sterility testing
Vaccines and other Biologics 9-12 December, 2024, virtual Webinair, EMA, virtual (2024) Keywords: Vaccine- OMCL- lot release Health Topics: Vaccine batch conformity Vaccin lot conformiteit Conformité de lot ...
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 ...
Guideline for Monovalent or Multivalent Meningococcal Conjugate Vaccine
Publication Type: Sci. report, recommendat°, guidance doc., directive, monograph Authors: Tesolin, L.; Bruysters, M.; Campitelli, L.; Pullirsch, D.; Oppling, V.; Garcia, D. Source: EDQM, 18/11/2024, ...
Advanced GMP/CMC
Publication Type: Scientific poster, presentation or proceeding Authors: Wim Van Molle; Koen Brusselmans Source: Capacity Building for vaccine manufacturers in Iran, Issue European Centre for ...
Guideline for Respiratory Syncytial Virus (mRNA) Vaccine
Publication Type: Sci. report, recommendat°, guidance doc., directive, monograph Authors: Tesolin, L.; Bruysters, M.; Campitelli, L.; Pullirsch, D.; Oppling, V.; Garcia, D. Source: EDQM, Strasbourg ...
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 ...
What qualification work is needed for 3D mucosal models for vaccine development
development, EVI, Issue RIVM, Bilthoven, The Netherlands (2024) Keywords: mucosal model development vaccine Service: Qualité des vaccins et produits sanguins Kwaliteit van vaccins en bloedproducten Quality of ...
Communication on out of specification results for vaccine Drug Substances
Publication Type: Scientific poster, presentation or proceeding Authors: Karine Meunier; Stéphane Maisonneuve; François Cano; Wim Van Molle; Camille Domicent; Florence Masquelier Source: Annual OMCL ...