Zoekresultaten - 41 results
Appoaching EMA and National regulatory authorties: who, when and how.
Publication Type: Scientific poster, presentation or proceeding Authors: Wim Van Molle Source: 2017 Vaccines Bioprocess Development & Commercialization Workshop, MIT Center for Biomedical Innovation (CBI), Issue MIT Center for Biomedical Innovation (C ...
Panel discussion on CMC for vaccines: "Responding in Time: Dealing with Predictable and Unpredictable"
Publication Type: Scientific poster, presentation or proceeding Authors: Wim Van Molle Source: 2017 Vaccines Bioprocess Development & Commercialization Workshop, MIT Center for Biomedical Innovation (CBI), Issue MIT Center for Biomedical Innovation (C ...
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, Cambridge, MA, USA (2017) Keywords: vaccine Health Topics: Va ...
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, Cambridge, MA, USA (2017) Keywords: vaccine Health Topics: Va ...
Quality Control of Polysaccharide Vaccines by the Belgian National Control Lab (OMCL) in the European Batch Release Framework: Activity Report 2016
Publication Type: Sci. report, recommendat°, guidance doc., directive, monograph Authors: L. Tesolin; Wim Van Molle Source: Scientific Institute of Public Health, Brussels, Belgium, p.59 (2017) ISBN: D/2017/2505/44 Accession Number: D/2017/2505/44 Keyword ...
Evaluation of quality and non-clinical data for licencing of vaccines
Publication Type: Scientific poster, presentation or proceeding Authors: Wim Van Molle Source: WHO GLO Evaluation of quality and non-clinical data for licensing of vaccines, WHO, Issue WHO, Athens, Greece (2016) Keywords: vaccine Health Topics: Vaccine b ...
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.
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 Health Topics: Vaccine batch conformity Vaccin lot conf ...
The Biological Standardisation activities at the international level
Publication Type: Scientific poster, presentation or proceeding Authors: Wim Van Molle Source: Quality control and batch release of vaccines and blood products in Europe, WIV-ISP, Issue WIV-ISP, Brussels, Belgium (2015) Keywords: Activity at batch release ...
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 Topics: Vaccine batch conformity Vaccin lot conformiteit ...