Zoekresultaten - 6 results
Training on the assessment of quality part (M3) of the eCTD for the registration of vaccines for human use
registration of vaccines for human use, Sciensano, Brussels, Belgium (2023) Keywords: assessment module 3 vaccines Health Topics: Vaccine batch conformity Vaccin lot conformiteit Conformité de lot de vaccin ...
The Role of EDQM and OMCLs
Publication Type: Scientific poster, presentation or proceeding Authors: Wim Van Molle Source: Training « Responsable des affaires réglementaires ", In Vivo, Issue In Vivo, Nivelles, Belgium ...
Testing of expired Synflorix bulks: actions taken by three OMCLs and concerns raised by another OMCL.
Publication Type: Scientific poster, presentation or proceeding Authors: Wim Van Molle Source: Annual OMCL meeting, EDQM, Issue EDQM, Brussels, Belgium (2015) Keywords: batch release meeting TESTING ...
The Biological Standardisation activities at the international level
Brussels, Belgium (2015) Keywords: Activity at batch release blood Control Europe International LEVEL PRODUCTS Quality Quality Control vaccine vaccines Health Topics: Vaccine batch conformity Vaccin lot ...
Vaxelis (PR5I): another fully liquid hexavalent vaccine on the EU market in 2016.
Publication Type: Scientific poster, presentation or proceeding Authors: Wim Van Molle Source: Annual OMCL meeting, EDQM, Issue EDQM, Brussels, Belgium (2015) Keywords: EU meeting ON vaccine Health ...
Implementation over the past 20 years of the 3R's principle for batch release at the Scientific Institute of Public Health, Belgium (IPH).
batch release Belgium Case Cell challenge Control data Diphtheria DRUG European Gain general health Healthy implementation in vivo Institute IS IT Laboratories measure measures medicinal product Medicine ...