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Filters: Author is Wim Van Molle
Round table Q&A on Vaccine Lifecycle management,
, PDA Biomanufacturing Conference "Biopharmaceutical Solutions to Prepare for Healthcare Challenges",, 20/09/2022, Amsterdam, The Netherlands, (2022)
Sustainability in Quality Control of Vaccines: Applying the 3R’s principle and implementing the 4th R. ,
, PDA Biomanufacturing Conference "Biopharmaceutical Solutions to Prepare for Healthcare Challenges", 21/09/2022, Amsterdam, The Netherlands, (2022)
White paper recommendations summary,
, Inno4Vac ST2 (Chimichurri) Stakeholders meeting, 4/10/2022, Florence, Italy, (2022)
WP20 Regulatory. Workshop outcome, dissemination, gaps, and next steps: from models to showcases,
, Inno4Vac 1st Annual Meeting 2022, 6/10/2022, Siena, Italy, (2022)
Controlled Human Infection Studies: Proposals for guidance on how to design, develop and produce a challenge strain.,
, Biologicals, 2021 Nov, Volume 74, (2021)
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 , 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)