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Zoekresultaten - 28 results
The vaccine Batch release procedure in Europe
Publication Type: Scientific poster, presentation or proceeding Authors: L. Tesolin Source: Seminaire ULB Pharmacien d'industrie, ULB, ULB pharmacie (2022) Keywords: batch release Europe OMCL ...
Vaccine quality control in Europe: monitoring the quality of vaccines after licensing
Publication Type: Scientific poster, presentation or proceeding Authors: Lieke Maria van der Aa Source: Immunity for Health, Flanders Vaccine, Issue Flanders Vaccine, Antwerp, Belgium (2020) Keywords: Quality Control vaccine Health Topics: Effectiveness ...
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 ...
Use of Whole Genome Sequencing Data for a First in Silico Specificity Evaluation of the RT-qPCR Assays Used for SARS-CoV-2 Detection.
China Center for Disease Control and prevention (CDC), which exhibits three primer mismatches present in 358 SARS-CoV-2 genomes sequenced mainly in Europe from February 2020 onwards. The best results were ...
Human challenge trial workshop: Focus on quality requirements for challenge agents, Langen, Germany, October 22, 2019.
exposure studies need to be safe and results should be meaningful, e.g. contribute to a better cure. Both in the US and in Europe, the level of Good Manufacturing Practice required is related to the phase of ...
The role of liquid chromatography and gas chromatography in the analysis of illegal medicines and health products
Publication Type: Peer reviewed scientific article Authors: Yaxin Tie; Celine Vanhee; Erwin Adams; Eric Deconinck Source: LC-GC Europe, Volume 32, Issue 2, Number 93 (2019) Health Topics: ...
A new approach to define acceptance limits for hematology in external quality assessment schemes.
Barbara; Plum, Inger; Guyard, Anne; Ana Paula Favia; Wim Coucke Source: Clin Chem Lab Med, Volume 55, Issue 12, p.1936-1942 (2017) Keywords: Erythrocyte Indices Erythrocytes Europe Hematocrit Hematology ...
OMCL's role in OOS evaluation and communication with partners (network, MAH and beyond) and tools available
HealthCare (EDQM),Council of Europe, NA (2016) Keywords: Communication EVALUATION meeting Network Role Health Topics: Effectiveness and safety of vaccines, medicines and health products- Quality of medical ...
Tetravac/Pentavac vaccines: follow-up on the aP immunogenicity assay situation
European Directorate for the Quality of Medicines & HealthCare (EDQM),Council of Europe, NA (2016) Keywords: Follow up FOLLOW-UP meeting ON situation vaccine vaccines Health Topics: Effectiveness and ...
Summary of method transfer for the new GSK vaccine Mosquirix at WIV-ISP
(EDQM),Council of Europe, NA (2016) Keywords: at meeting method summary vaccine WIV-ISP Health Topics: Effectiveness and safety of vaccines, medicines and health products- Quality of medical laboratories ...