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Best practices for lot release of mRNA vaccines
Workshop, WHO, Cairo, Egypt (2024) Keywords: batch release mRNA Quality vaccine Health Topics: Vaccine batch conformity Vaccin lot conformiteit Conformité de lot de vaccin Service: Qualité des vaccins et ...
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.
Challenges in Vaccines Supply to Developing Countries, PDA Europe, Issue PDA Europe, Berlin, Germany (2015) Keywords: a abstract approach approaches batch release challenge CHALLENGES conference Countries ...
Impact on the Immmunogenicity and Safety of Tetanus Toxoid Vaccine in Controlled Temperature Chain and Standard Cold chain (WHO/Epicentre project)
Publication Type: Scientific poster, presentation or proceeding Authors: Geneviève Waeterloos; WIV-ISP Source: Quality control and batch release of vaccines and blood products in Europe, Issue ...
Regulatory issues regarding manufacture and control of vaccine adjuvants. The EU situation.
at batch release Belgian Change Clinical clinical trial Clinical trials Combination Components Control developing Development distribution EU European future Group Guidelines health Hepatitis Hepatitis ...
Calibration of the Ph. Eur. Biological Reference Preparation (BRP) for Tetanus Vaccine (Adsorbed) Batch 3).
World Health Organization (WHO)/National Institute for Biological Standards and Control (NIBSC) to establishreplacement batches for the European Pharmacopoeia (Ph. Eur.) Tetanus Vaccine (adsorbed) ...
Collaborative study for the standardisation of the histamine sensitizing test in mice and the CHO cell-based assay for the residual toxicity testing of acellular pertussis vaccines.1
Pharmacopoeia (Ph. Eur.) and the World Health Organisation (WHO) require the performance of extensive quality and safety control testing before the release on the market of vaccine products for human use. Safety ...
Panel discussion on the adoption of 3Rs and non-animal approaches for quality control and batch release testing of these products
Publication Type: Scientific poster, presentation or proceeding Authors: Geneviève Waeterloos Source: https://www.nc3rs.org.uk/events/nc3rs-workshop-implementing-3rs-who-guidelines-understanding-impact-quality-control ...
Viewpoint or an EU OMCL on OCABR and Batch Release fro outside the EU
OMCL network Extranet, Issue EDQM, Strasbourg, France (2023) Keywords: Vaccine- Quality control- Batch Release- WHO Health Topics: Effectiveness and safety of vaccines, medicines and health products- ...