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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 ...
The EMA PRIME procedure in an accelerated assessment environment for vaccine licensure: Experiences from quality (CMC) assessors. A case study for Ebola vaccine.
Publication Type: Scientific poster, presentation or proceeding Authors: Wim Van Molle; Koen Brusselmans Source: 2020 PDA EUROPE- Driving Biopharmaceutical Innovations & Sustainability ...
Tetravac/Pentavac vaccines: follow-up on the aP immunogenicity assay situation
Publication Type: Scientific poster, presentation or proceeding Authors: C. Domicent; M. Lejeune; V. Stygelbout; Koen Brusselmans; Geneviève Waeterloos Source: OMCL ANNUAL MEETING 2016, NA, Issue ...
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 ...
Expertise activities: participation in licensing procedures for vaccines and plasma-derived products
Publication Type: Scientific poster, presentation or proceeding Authors: Koen Brusselmans Source: Quality control and batch release of vaccines and blood products in Europe, NA, Issue WIV-ISP, NA ...
Regulatory issues regarding manufacture and control of vaccine adjuvants. The EU situation.
Publication Type: Scientific poster, presentation or proceeding Authors: Wim Van Molle; Koen Brusselmans; L. Tesolin; Geneviève Waeterloos Source: Modern Vaccines/adjuvants Formulation: Impact On ...
Use of Next Generation Sequencing in Adventitious Virus Screening of Biological Medicinal Products: Regulatory Requirements
Publication Type: Scientific poster, presentation or proceeding Authors: Koen Brusselmans Source: 3rd Conference on Next Generation Sequencing for Adventitious Virus Detection in Biologics for ...