Primaire tabs

2018
The Role of EDQM and OMCLs, Van Molle, W. , Responsable des affaires réglementaires, 15/01/2018, Issue Culture in vivo ASBL, (2018)
The Role of EDQM and OMCLs, Van Molle, W. , Responsable des affaires réglementaires , 18/12/2018, Issue Culture in vivo ASBL, (2018)
2017
Appoaching EMA and National regulatory authorties: who, when and how., Van Molle, W. , 2017 Vaccines Bioprocess Development & Commercialization Workshop, 2017, Issue MIT Center for Biomedical Innovation (CBI), Cambrige, MA, USA, (2017)
Evaluation of quality and non-clinical data for licencing of vaccines, Van Molle, W. , WHO GLO Evaluation of quality and non-clinical data for licensing of vaccines, 2017, Issue WHO, Athens, Greece, (2017)
Method transfer of the hexavalent vaccine Vaxelis: a bumpy road with a happy ending, Van Molle, W. , OMCL Annual Meeting, 2017, Issue EDQM, Budapest, Hungary, (2017)
Panel discussion on CMC for vaccines: "Responding in Time: Dealing with Predictable and Unpredictable", Van Molle, W. , 2017 Vaccines Bioprocess Development & Commercialization Workshop, 2017, Issue MIT Center for Biomedical Innovation (CBI), Cambrdige, MA, USA, (2017)
Panel discussion on specifications for biologicals, Van Molle, W. , 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, Tesolin, L., and Van Molle W. , 2017, Brussels, Belgium, p.59, (2017)
The Role of EDQM and OMCLs, Van Molle, W. , 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., Van Molle, W. , 2017 BioMAN Workshop on Setting Specifications for Biotherapeutic Products, 2017, Issue BioMAN, Cambridge, MA, USA, (2017)
2016
Evaluation of quality and non-clinical data for licencing of vaccines, Van Molle, W. , 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, Van Molle, W. , WHO GLO product evaluation course, 29/2/2016, Issue WHO, Antalya, Turkey, (2016)
The Role of EDQM and OMCLs, Van Molle, W. , Training « Responsable des affaires réglementaires ", 19/1/2016, Issue In Vivo, Nivelles, Belgium, (2016)
2015
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., Van Molle, W., Tesolin L., Brusselmans K., and Waeterloos G. , 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, Van Molle, W. , 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, Van Molle, W. , 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, Van Molle, W. , Biological Production Forum 2015, 0/0/2015, Issue WTG Events, Düsseldorf, Germany, (2015)
Panel discussion on quality by design, Van Molle, W. , 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, Tesolin, L., and Van Molle W. , 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., Van Molle, W. , Biological Production Forum 2015, 2015, Issue WTG Events, Düsseldorf, Germany, (2015)
Regulatory Position on Specification Settings, Van Molle, W. , 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, Van Molle, W. , 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., Van Molle, W. , Annual OMCL meeting, 0/0/2015, Issue EDQM, Brussels, Belgium, (2015)

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