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Filters: Auteur is Wim Van Molle
The Role of EDQM and OMCLs,
, Responsable des affaires réglementaires, 13/01/2021, Issue Culture in vivo ASBL, (2021)
Round table discussion,
, Human Infection Studies Considerations on manufacturing of challenge agents- viruses (SARS-CoV-2/COVID-19) and parasites as examples A Joint Wellcome Trust/HIC-Vac, hVIVO and IABS webina, 31/01/2021, (2021)
The EMA PRIME procedure in an accelerated assessment environment for vaccine licensure: Experiences from quality (CMC) assessors. A case study for Ebola vaccine.,
, 2020 PDA EUROPE - Driving Biopharmaceutical Innovations & Sustainability BioManufacturing, 22/09/2020, (2020)
Guidelines on the quality, safety and efficacy of respiratory syncytial virus vaccines,
, 2020, Volume 1024, Issue Annex 2, Number 199, p.106, (2020)
Human challenge trial workshop: Focus on quality requirements for challenge agents, Langen, Germany, October 22, 2019.,
, Biologicals, 2020 Jul, Volume 66, (2020)
Panel discussion on CMC in 'Risk- based strategies to support current health emergency,
, World Vaccine Conference (EU) , 20/10/2020, Web based, (2020)
Panel discussion on IABS Webinar on CHIM and COVID19,
, SARS CoV-2 CHIM Webinar, 23/06/2020, Issue IABS, (2020)
The Role of EDQM and OMCLs,
, Responsable des affaires réglementaires, 13/01/2020, Issue Culture in vivo ASBL, (2020)
Adjuvants for vaccines, A need for quality time ?,
, COST regulatory workshop on adjuvants, 09/2019, (2019)
Batch release of vaccines in Europe: from method transfer to first commercial batch available on the market. Straightforward approach that requires a proactive mindset of the manufacturer.,
, EDQM & European Pharmacopoeia: State-of-the-Art Science for Tomorrow’s Medicines, 19-20 May 2019, Issue EDQM, (2019)
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, 15/01/2018, Issue Culture in vivo ASBL, (2018)
The Role of EDQM and OMCLs,
, Responsable des affaires réglementaires , 18/12/2018, 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)