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Filters: Author is Wim Van Molle
Closing Session: Health Emergencies Preparedness for the Future Panel Discussion,
, 2023 PDA BioManufacturing Conference Agility and Biomanufacturing Excellence to Meet Patients’ Needs, 13/09/2023, Issue PDA, (2023)
Development of a multiplex-based immunoassay for the characterization of diphtheria, tetanus and acellular pertussis antigens in human combined DTaP vaccines.,
, J Immunol Methods, 2023 Jun, Volume 517, (2023)
EU batch release procedure: Annual Report 2 - Batch Release of Vaccines,
, 2023 05 25, p.314, (2023)
The IMI Inno4Vac project: a public-private partnership focussing on Innovations to accelerate vaccine development and manufacture,
, 2023 PDA BioManufacturing Conference Agility and Biomanufacturing Excellence to Meet Patients’ Needs, 12/09/2023, Issue PDA, Seville, Spain, (2023)
Rational arguments for regulatory acceptance of consistency testing: benefits of non-animal testing over release testing of vaccines.,
, Expert Rev Vaccines, 2023 Apr 03, Volume 22, Issue 1, Number 377, (2023)
Regulatory expectations on the use of vaccine reference standards for maintaining product quality.,
, Maintaining the Quality of Vaccines through the Use of Standards: Current Challenges and Future Opportunities, 21/06/2023, Issue IABS, Ottawa, Canada, (2023)
Regulatory progress and future plans,
, Inno4Vac 2nd annual meeting 2023, 5/10/2023, Lyon, France, (2023)
The Role of EDQM and OMCLs,
, Responsable des affaires réglementaires, 26/01/2023, Issue Culture in vivo ASBL, (2023)
Round table discussion,
, Maintaining the Quality of Vaccines through the Use of Standards: Current Challenges and Future Opportunities, 22/06/2023, Issue IABS, Ottawa, Canada, (2023)
Training on the assessment of quality part (M3) of the eCTD for the registration of vaccines for human use,
, Training on The assessment of quality part (M3) of the eCTD for the registration of vaccines for human use, 15/11/2023, Brussels, Belgium, (2023)
What do we request for production and quality control of CHIM strains.Should it be GMP or is adherence to GMP acceptable ?,
, Ethical Approval for CHIM Clinical Trial Protocols, 30/05/2023, Brussels, Belgium, (2023)
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)