Wim Van Molle

2017

Panel discussion on specifications for biologicals, Van Molle, Wim , 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 Wim , 2017, Brussels, Belgium, p.59, (2017)

The Role of EDQM and OMCLs, Van Molle, Wim , 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, Wim , 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, Wim , 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, Wim , WHO GLO product evaluation course, 29/2/2016, Issue WHO, Antalya, Turkey, (2016)

The Role of EDQM and OMCLs, Van Molle, Wim , 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, Wim, Tesolin L., Brusselmans Koen, and Waeterloos Geneviève , 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, Wim , 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, Wim , 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, Wim , Biological Production Forum 2015, 0/0/2015, Issue WTG Events, Düsseldorf, Germany, (2015)

Panel discussion on quality by design, Van Molle, Wim , 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 Wim , 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, Wim , Biological Production Forum 2015, 2015, Issue WTG Events, Düsseldorf, Germany, (2015)

Regulatory Position on Specification Settings, Van Molle, Wim , 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, Wim , 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, Wim , Annual OMCL meeting, 0/0/2015, Issue EDQM, Brussels, Belgium, (2015)

Vaxelis (PR5I): another fully liquid hexavalent vaccine on the EU market in 2016., Van Molle, Wim , Annual OMCL meeting, 0/0/2015, Issue EDQM, Brussels, Belgium, (2015)

2014

Evaluation of quality and non-clinical data for licencing of vaccines, Van Molle, Wim , 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, Tesolin, L., and Van Molle Wim , 2014, Brussels, Belgium, p.74, (2014)

2013

European accreditation bodies require the OMCL participation in proficiency studies independently of the performance of blind testing: a trend or a reality, Waeterloos, Geneviève, and Van Molle Wim , Annual OMCL meeting, 12/6/2013, Issue EDQM, NA, (2013)

Evaluation of quality and non-clinical data for licencing of vaccines, Van Molle, Wim , WHO GLO product evaluation course, 0/0/2013, Issue WHO, NA, (2013)

Hexacima: a fully liquid hexavalent vaccine (soon) on the market, Van Molle, Wim , 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, Van Molle, Wim , 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., Tesolin, L., and Van Molle Wim , 0/10/2013, Brussels, Belgium, p.49, (2013)