Search results - 12 results
Method transfer of the hexavalent vaccine Vaxelis: a bumpy road with a happy ending
products Full text language: English Category: C31 FOS Classification: 3.03 Health sciences ...
The Role of EDQM and OMCLs
bloedproducten Quality of vaccines and blood products Full text language: English Category: C33 FOS Classification: 3.03 Health sciences ...
Evaluation of quality and non-clinical data for licencing of vaccines
bloedproducten Quality of vaccines and blood products Full text language: English Category: C31 FOS Classification: 3.03 Health sciences ...
Appoaching EMA and National regulatory authorties: who, when and how.
Service: Qualité des vaccins et produits sanguins Kwaliteit van vaccins en bloedproducten Quality of vaccines and blood products Full text language: English Category: C31 FOS Classification: 3.03 Health ...
Panel discussion on CMC for vaccines: "Responding in Time: Dealing with Predictable and Unpredictable"
Service: Qualité des vaccins et produits sanguins Kwaliteit van vaccins en bloedproducten Quality of vaccines and blood products Full text language: English Category: C31 FOS Classification: 3.03 Health ...
Setting specifications for Biologicals. Points to consider from simple to complex. Case study for viral vectored vaccines.
Publication Type: Scientific poster, presentation or proceeding Authors: Wim Van Molle Source: 2017 BioMAN Workshop on Setting Specifications for Biotherapeutic Products, BioMAN, Issue BioMAN, ...
Panel discussion on specifications for biologicals
Publication Type: Scientific poster, presentation or proceeding Authors: Wim Van Molle Source: 2017 BioMAN Workshop on Setting Specifications for Biotherapeutic Products, BioMAN, Issue BioMAN, ...
Evaluation of quality and non-clinical data for licencing of vaccines
bloedproducten Quality of vaccines and blood products Full text language: English Category: C31 FOS Classification: 3.03 Health sciences ...
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.
medicinal products or medicinal products derived from human blood or plasma by an Official Medicines Control Laboratory (OMCL) before these can be marketed. The competent authorities issue a Batch Release ...
Testing of expired Synflorix bulks: actions taken by three OMCLs and concerns raised by another OMCL.
Quality of vaccines and blood products Full text language: English Category: C31 FOS Classification: 3.03 Health sciences ...