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Filters: Author is L. Tesolin
Advanced Analysis of Biopharmaceuticals: Endotoxin content & Sterility testing,
, African Medicines Regulatory Harmonization (AMRH) 5th Continental GMP Training Workshop: A focus on Vaccines and other Biologics 9-12 December, 2024, virtual Webinair, 09/12/2024, virtual, (2024)
The batch release procedure in Europe,
, Seminaire etudiants en pharmacie ULB, 22/11/2024, ULB Brussels, (2024)
CHIKUNGUNYA VIRUS (LIVE ATTENUATED),
, 01/07/2024, Strasbourg (F), p.15, (2024)
EU Annual report : batch release of human vaccines,
, 01/04/2024, Brussels, Belgium, p.261, (2024)
Guideline for Monovalent or Multivalent Meningococcal Conjugate Vaccine,
, 18/11/2024, 18/11/2024, p.19, (2024)
Guideline for Respiratory Syncytial Virus (mRNA) Vaccine,
, 17/09/2024, Strasbourg (F), p.18, (2024)
Implementing the 3RS in quality Control and batch release testing - view from a Belgian OMCL,
, AFMPS - Advancing the 3Rs for Regulatory Testing of Medicines-31/01/2024-Antwerpen, Belgium, 31/01/2024, Brussels, Belgium, (2024)
regulatory roadmap for 3D mucosal model development, an overview,
, ECR Trimestrial meeting Inno4vac, virtual, 17/06/2024, virtual, (2024)
What qualification work is needed for 3D mucosal models for vaccine development,
, A regulatory exchange on model characterization and qualification of 3D mucosal models for vaccine development , 06/06/2024, Issue RIVM, Bilthoven, The Netherlands, (2024)
WHO Guidelines on Post Approval Changes- Appendix 1 Reporting categories and suggested review timelines,
, Workshop on management of post approval changes, 03-05/12/2024, Hanoi -Viet Nam, 05/12/2024, Hanoi, Viet Nam, (2024)
WHO Guidelines on Post approval Changes- Appendix 2+3 Reporting procedures and data requirements for quality changes to antigens + finished products,
, Workshop on management of post approval changes, 03-05/12/2024, Hanoi -Viet Nam , 04/12/2024, Hanoi, Viet Nam, (2024)
Comment implémenter l'analyse de tendance,
, Webinar ARP Senegal, 12/09/2023, Sciensano, Brussels, (2023)
Development of a multiplex-based immunoassay for the characterization of diphtheria, tetanus and acellular pertussis antigens in human combined DTaP vaccines.,
, J Immunol Methods, 2023 Jun, Volume 517, (2023)
EU batch release procedure: Annual Report 2 - Batch Release of Vaccines,
, 2023 05 25, p.314, (2023)
l'analyse de tendance-concepts préliminaires,
, webinar ARP Senegal, 12/09/2023, Sciensano, Brussels, (2023)
OCABR: Respiratory Syncytial Virus (rDNA) Vaccine,
, 29/09/2023, Strasbourg (F), p.15, (2023)
Phase 2 testing: where are we now?,
, OMCL Annual Meeting EDQM 2023, 06/2023, Madrid, SPain, (2023)
Rational arguments for regulatory acceptance of consistency testing: benefits of non-animal testing over release testing of vaccines.,
, Expert Rev Vaccines, 2023 Apr 03, Volume 22, Issue 1, Number 377, (2023)
Report of WHO Drafting Group meeting to revise WHO Guidelines on procedures and data requirements for changes to approved vaccines,
, 10/10/2023, Geneva, switzerland, p.9, (2023)
A roadmap for regulatory implementation of in vitro models for evaluation of vaccine efficacy,
, 08/2023, Niagara falls, Canada, (2023)
Training on the assessment of quality part (M3) of the eCTD for the registration of vaccines for human use,
, Training on The assessment of quality part (M3) of the eCTD for the registration of vaccines for human use, 15/11/2023, Brussels, Belgium, (2023)
The vaccine Batch release procedure in Europe,
, Seminaire etudiants en pharmacie ULB, 04/12/2023, Brussels, Belgium, (2023)
WHO Drafting Group meeting to revise WHO Guidelines on PAC- outcome of workshops,
, WHO Drafting Group meeting to revise WHO Guidelines on procedures and data requirements for changes to approved vaccines, 20/09/2023, Frankfurt, Germany, (2023)
Auditors experience with remote audits:Preparatory phase,
, OMCL annual meeting 2022, 14/06/2022, EDQM, strasbourg, (2022)
The batch release procedure in Europe,
, Seminaire etudiants en pharmacie ULB, 05/12/2022, Brussels, Belgium, (2022)