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Exporteer 89 resultaten:
Filters: Auteur is Wim Van Molle
How, where and when to get and/ask for information and help,,
, COST regulatory workshop on adjuvants, 09/2019, (2019)
O-acetyl content testing in meningoccocal vaccine from an OMCL perspective,
, OMCL annual meeting, (2019)
Scientific & organizing committee and Chair,
, Focus on Quality Requirements for Challenge Agents, 22/10/2019, Issue IABS, (2019)
The Role of EDQM and OMCLs,
, Responsable des affaires réglementaires , 18/12/2018, Issue Culture in vivo ASBL, (2018)
The Role of EDQM and OMCLs,
, Responsable des affaires réglementaires, 15/01/2018, Issue Culture in vivo ASBL, (2018)
Appoaching EMA and National regulatory authorties: who, when and how.,
, 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,
, 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,
, OMCL Annual Meeting, 2017, Issue EDQM, Budapest, Hungary, (2017)
Panel discussion on CMC for vaccines: "Responding in Time: Dealing with Predictable and Unpredictable",
, 2017 Vaccines Bioprocess Development & Commercialization Workshop, 2017, Issue MIT Center for Biomedical Innovation (CBI), Cambrdige, MA, USA, (2017)
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)