Onglets principaux
Exporter 89 resultats:
Filtres: Auteur is Wim Van Molle
WP20 Regulatory update,,
, Inno4Vac 2nd annual meeting 2023, 5/10/2023, Lyon, France, (2023)
Auditors experience with remote audits:Preparatory phase,
, OMCL annual meeting 2022, 14/06/2022, EDQM, strasbourg, (2022)
Considerations on the principles of development and manufacturing qualities of challenge agents for use in human infection models,
, 1/01/2022, (2022)
The consistency approach for the substitution of in vivo testing for the quality control of established vaccines: practical considerations and progressive vision,
, Open Research Europe, 13/12/2022, (2022)
eCTD structure & registration procedures,
, Inno4Vac SubTopic 4 (VAXinS) F2F Meeting, 22/02/2022, Copenhagen, Denmark, (2022)
Multiple cases of OOS batches. Investigations and actions taken and to take,
, Annual OMCL meeting, 16/06/2022, Issue EDQM, Strasbourg, France, (2022)
Regulatory: outcomes of 3 STs Regulatory workshops and future plans ,
, Inno4Vac 1st Annual Meeting 2022, 6/10/2022, Siena, Italy, (2022)
The Role of EDQM and OMCLs,
, Responsable des affaires réglementaires, 19/01/2022, Issue Culture in vivo ASBL, (2022)
Round table Q&A on sustainability and digitalization,
, PDA Biomanufacturing Conference "Biopharmaceutical Solutions to Prepare for Healthcare Challenges", 21/09/2022, Amsterdam, The Netherlands, (2022)
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)