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2024
Accelerating vaccine manufacturing development through model-based approaches: current advances and future opportunities, Ramin, Elham, Cardillo Antonio Gaetano, Liebers Reinhard, Schmölder Johannes, von Lieres Eric, Van Molle Wim, Niebel Bastian, Natalis Laurent, Meln Irina, Perea-Vélez Mónica, et al. , Current Opinion in Chemical Engineering, Volume 43, (2024)
Ethical approval for controlled human infectious model clinical trial protocols - A workshop report., Euzebiusz, Jamrozik, Katherine Littler, Irina Meln, Van Molle Wim, Sandra Morel, F Olesen, Ole, Michelle Rubbrecht, Shobana Balasingam, and Neels Pieter , Biologicals, 2024 Feb, Volume 85, (2024)
Maintaining the quality of vaccines through the use of standards: Current challenges and future opportunities., C, Sajjadi, Nancy, Ryan Brady, Carmen Jungbäck, Laurent Mallet, Catherine Milne, Sandra Prior, Gayle Pulle, Peter Rigsby, Tim Schofield, Richard Siggers, et al. , Biologicals, 2024 Mar 12, Volume 86, (2024)
Regulatory workshop on challenge strain development and GMP manufacture - A stakeholder meeting report., Nicoletta, Corti, Christopher Chiu, J Cox, Rebecca, Clarisse Demont, Jeanne-Marie Devaster, G Engelhardt, Othmar, Andrew Gorringe, Khaole Hassan, Marcel Hoefnagel, Ingrid Kamerling, et al. , Biologicals, 2024 Feb, Volume 85, (2024)
The Role of EDQM and OMCLs, Van Molle, Wim , Training « Responsable des affaires réglementaires », 24/01/2024, Issue Culture in vivo ASBL, (2024)
2023
Closing Session: Health Emergencies Preparedness for the Future Panel Discussion, Van Molle, Wim , 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., Vermeulen, Maxime, Feck Isabelle, Francotte Antoine, Hassall Laura, Tesolin L., Van Molle Wim, Pizzato Romain, Laurent Thierry, Hoebreck Charline, Stickings Paul, et al. , J Immunol Methods, 2023 Jun, Volume 517, (2023)
EU batch release procedure: Annual Report 2 - Batch Release of Vaccines, Waeterloos, Geneviève, Auquier J., Domicent C., Cuignet L., Clouet S., Desmet N., Florens Morgane, Laurent F., Masquelier F., Ribaucour F, et al. , 2023 05 25, p.314, (2023)
The IMI Inno4Vac project: a public-private partnership focussing on Innovations to accelerate vaccine development and manufacture, Van Molle, Wim , 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., Hoefnagel, Marcel H. N., Stickings Paul, Smith Dean, Jungbäck Carmen, Van Molle Wim, and Tesolin L. , 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., Van Molle, Wim , 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, Van Molle, Wim , Inno4Vac 2nd annual meeting 2023, 5/10/2023, Lyon, France, (2023)
The Role of EDQM and OMCLs, Van Molle, Wim , Responsable des affaires réglementaires, 26/01/2023, Issue Culture in vivo ASBL, (2023)
Round table discussion, Van Molle, Wim , 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, Brusselmans, Koen, Van Molle Wim, and Tesolin L. , 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 ?, Van Molle, Wim , Ethical Approval for CHIM Clinical Trial Protocols, 30/05/2023, Brussels, Belgium, (2023)
WP20 Regulatory update,, Van Molle, Wim , Inno4Vac 2nd annual meeting 2023, 5/10/2023, Lyon, France, (2023)
2022
Auditors experience with remote audits ‘Preparatory phase’ , Waeterloos, Geneviève, Tesolin L., and Van Molle Wim , 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, Van Molle, Wim , 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, Tesolin, L., Dierick J.-F., and Van Molle Wim , Open Research Europe, 13/12/2022, (2022)
eCTD structure & registration procedures, Van Molle, Wim , Inno4Vac SubTopic 4 (VAXinS) F2F Meeting, 22/02/2022, Copenhagen, Denmark, (2022)
Multiple cases of OOS batches. Investigations and actions taken and to take, Van Molle, Wim , Annual OMCL meeting, 16/06/2022, Issue EDQM, Strasbourg, France, (2022)
Regulatory: outcomes of 3 STs Regulatory workshops and future plans , Van Molle, Wim , Inno4Vac 1st Annual Meeting 2022, 6/10/2022, Siena, Italy, (2022)
The Role of EDQM and OMCLs, Van Molle, Wim , Responsable des affaires réglementaires, 19/01/2022, Issue Culture in vivo ASBL, (2022)
Round table Q&A on sustainability and digitalization, Van Molle, Wim , PDA Biomanufacturing Conference "Biopharmaceutical Solutions to Prepare for Healthcare Challenges", 21/09/2022, Amsterdam, The Netherlands, (2022)

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