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Onglets principaux
Exporter 80 resultats:
Filtres: Auteur is Wim Van Molle
Panel discussion on specifications for biologicals,
, 2017 BioMAN Workshop on Setting Specifications for Biotherapeutic Products, 2017, Issue BioMAN, Cambridge, MA, USA, (2017)
Quality Control of Polysaccharide Vaccines by the Belgian National Control Lab (OMCL) in the European Batch Release Framework : Activity Report 2016,
, 2017, Brussels, Belgium, p.59, (2017)
The Role of EDQM and OMCLs,
, Training « Responsable des affaires réglementaires ", 2017, Issue In Vivo, Nivelles, Belgium, (2017)
Setting specifications for Biologicals. Points to consider from simple to complex. Case study for viral vectored vaccines.,
, 2017 BioMAN Workshop on Setting Specifications for Biotherapeutic Products, 2017, Issue BioMAN, Cambridge, MA, USA, (2017)
Evaluation of quality and non-clinical data for licencing of vaccines,
, WHO GLO Evaluation of quality and non-clinical data for licensing of vaccines, 2016, Issue WHO, Athens, Greece, (2016)
Evaluation of quality and non-clinical data for licencing of vaccines,
, WHO GLO product evaluation course, 29/2/2016, Issue WHO, Antalya, Turkey, (2016)
The Role of EDQM and OMCLs,
, Training « Responsable des affaires réglementaires ", 19/1/2016, Issue In Vivo, Nivelles, Belgium, (2016)
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.,
, PDA Europe Conference Vaccines. Featuring WHO on Challenges in Vaccines Supply to Developing Countries, 0/11/2015, Issue PDA Europe, Berlin, Germany, (2015)
The Biological Standardisation activities at the international level,
, Quality control and batch release of vaccines and blood products in Europe, 0/0/2015, Issue WIV-ISP, Brussels, Belgium, (2015)
Evaluation of quality and clinical data for licencing of vaccines,
, Workshop on Advanced CTD evaluation for vaccines , 0/0/2015, Issue WHO, Teheran, Iran, (2015)
The Key to success in R&D : Into the minds of the Quality Assessors,
, Biological Production Forum 2015, 0/0/2015, Issue WTG Events, Düsseldorf, Germany, (2015)
Panel discussion on quality by design,
, PDA Europe Conference Vaccines. Featuring WHO on Challenges in Vaccines Supply to Developing Countries, 1/12/2015, Issue PDA Europe, Berlin, Germany, (2015)
Quality Control of polysaccharide Vaccines by the Belgian National Control Lab (OMCL) in the European Batch Release Framework : Activity Report 2014,
, 2015, Brussels, Belgium, p.73, (2015)
Regulatory panel discussion. An interactive panel discussion with key authoritative figures from various European regulatory agencies focusing on the regulation of the biologics industry.,
, Biological Production Forum 2015, 2015, Issue WTG Events, Düsseldorf, Germany, (2015)
Regulatory Position on Specification Settings,
, PDA Europe Conference Vaccines. Featuring WHO on Challenges in Vaccines Supply to Developing Countries, 0/12/2015, Issue PDA Europe, Berlin, Germany, (2015)
Round table discussion on posters: comparability and testing challenges,
, PDA Europe Conference Vaccines. Featuring WHO on Challenges in Vaccines Supply to Developing Countries,, 30/11/2015, Issue PDA Europe, Berlin, Germany, (2015)
Testing of expired Synflorix bulks: actions taken by three OMCLs and concerns raised by another OMCL.,
, Annual OMCL meeting, 0/0/2015, Issue EDQM, Brussels, Belgium, (2015)
Vaxelis (PR5I): another fully liquid hexavalent vaccine on the EU market in 2016.,
, Annual OMCL meeting, 0/0/2015, Issue EDQM, Brussels, Belgium, (2015)
Evaluation of quality and non-clinical data for licencing of vaccines,
, WHO GLO product evaluation course, 2014, Issue WHO, Tunis, Tunesia, (2014)
Quality Control of Polysaccharide Vaccines by the Belgian National Control Lab (OMCL) in the European Batch Release Framework : Activity Report 2013,
, 2014, Brussels, Belgium, p.74, (2014)
European accreditation bodies require the OMCL participation in proficiency studies independently of the performance of blind testing: a trend or a reality,
, Annual OMCL meeting, 12/6/2013, Issue EDQM, NA, (2013)
Evaluation of quality and non-clinical data for licencing of vaccines,
, WHO GLO product evaluation course, 0/0/2013, Issue WHO, NA, (2013)
Hexacima: a fully liquid hexavalent vaccine (soon) on the market,
, Annual OMCL meeting, 13/6/2013, Issue EDQM, Helsinki, Finnland, (2013)
Possible presence of particles in MMR vaccines detected by Egyptian OMCL resolved by interaction with Belgian OMCL and manufacture,
, Annual OMCL Meeting, 11/6/2013, Issue EDQM, Helsinki, Finnland, (2013)
Quality control of polysaccharide vaccines by the Belgian National Control Lab (OMCL) in the European batch release framework: activity report 2012.,
, 0/10/2013, Brussels, Belgium, p.49, (2013)