Search results - 41 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 (2024) Keywords: post approval changes vaccine Health Topics: ...
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 (2024) Keywords: post approval changes vaccine Health Topics: ...
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 Health Topics: Vaccine batch conformity Vaccin lot conformit ...
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 Workshop, WHO, Cairo, Egypt (2024) Keywords: batch release mRNA ...
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: https://connect.edqm.eu/accounts/login/?next=/home/ Keywords: in ...
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 (F), p.18 (2024) Accession Number: PA/PH/OMCL (24) 66 DEF ...
CHIKUNGUNYA VIRUS (LIVE ATTENUATED)
Publication Type: Sci. report, recommendat°, guidance doc., directive, monograph Authors: L. Tesolin; M. Bruysters; D. Garcia; V. Oppling; L. Campitelli; D. Pullirsch Source: EDQM, Strasbourg (F), p.15 (2024) Accession Number: PA/PH/OMCL (24) 49 DEF Keywo ...
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 regulatory roadmap Health Topics: Vaccine batch conformity ...
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 Extranet, Issue EDQM, Ohrid, North Macedonia (2024) URL: https:// ...