Advancing regulatory dialogue: In silico models for improved vaccine biomanufacturing - an expert meeting report., Irina, Meln, Van Molle Wim, Perea Vélez, Mónica, Greger Abrahamsen, Koen Brusselmans, Eric Calvosa, Gaetano Cardillo, Antonio, Didier Clénet, Caroline Forestieri, V Gernaey, Krist, et al. , Vaccine, 2025 May 22, Volume 56, (2025)

 DNA templates for the preparation of mRNA substances (5.40), Van Molle, Wim , 1/07/2025, Volume European Pharmacopoeia (Ph. Eur.) 12.1, (2025)

 mRNA Substances for the production of mRNA vaccines for human use (5.39), Van Molle, Wim , 1/07/2025, Volume European Pharmacopoeia (Ph. Eur.) 12.1, (2025)

mRNA vaccines for human use (5.36), Van Molle, Wim , 1/07/2025, Volume European Pharmacopoeia (Ph. Eur.) 12.1, (2025)

The Role of EDQM and OMCLs, Van Molle, Wim , Training "Responsable des affaires réglementaires", 14/03/2025, Issue Culture in vivo ASBL, (2025)

Session Chair: "Panel discussion: Feedback from regulators on Stability models", Van Molle, Wim , Second Regulatory Workshop on Utilizing In Silico Models to Expedite Vaccine Development, Testing, and Lifecycle Management, 27/05/2025, Brussels, Belgium, (2025)

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)

Advanced GMP/CMC, Van Molle, Wim, and Brusselmans Koen , Capacity Building for vaccine manufacturers in Iran, 29/10/2024, Issue European Centre for Clinical Research Training, (2024)

Communication on out of specification results for vaccine Drug Substances, Meunier, Karine, Maisonneuve Stéphane, Cano François, Van Molle Wim, Domicent C., and Masquelier F. , Annual OMCL Meeting, OCABR Vaccin Session, 16/05/2024, Issue EDQM, Ohrid, North Macedonia, (2024)

Ethical approval for controlled human infectious model clinical trial protocols - A workshop report., Euzebiusz, Jamrozik, Littler Katherine, Irina Meln, Van Molle Wim, Morel Sandra, Olesen Ole F., Rubbrecht Michelle, Balasingam Shobana, and Neels Pieter , Biologicals, 2024 Feb, Volume 85, (2024)

EU Annual report : batch release of human vaccines, Waeterloos, Geneviève, Van Molle Wim, Tesolin L., Ribaucour F, Florens Morgane, Masquelier F., Clouet S., Domicent C., Auquier J., Laurent F., et al. , 01/04/2024, Brussels, Belgium, p.261, (2024)

Maintaining the quality of vaccines through the use of standards: Current challenges and future opportunities., Sajjadi, Nancy C., Brady Ryan, Jungbäck Carmen, Mallet Laurent, Milne Catherine, Prior Sandra, Pulle Gayle, Rigsby Peter, Schofield Tim, Siggers Richard, et al. , Biologicals, 2024 Mar 12, Volume 86, (2024)

Regulatory workshop on challenge strain development and GMP manufacture - A stakeholder meeting report., Corti, Nicoletta, Chiu Christopher, Cox Rebecca J., Demont Clarisse, Devaster Jeanne-Marie, Engelhardt Othmar G., Gorringe Andrew, Khaole Hassan, Hoefnagel Marcel, 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)

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)

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)

Round table Q&A on Vaccine Lifecycle management, Van Molle, Wim , 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. , Van Molle, Wim , PDA Biomanufacturing Conference "Biopharmaceutical Solutions to Prepare for Healthcare Challenges", 21/09/2022, Amsterdam, The Netherlands, (2022)

White paper recommendations summary, Van Molle, Wim , Inno4Vac ST2 (Chimichurri) Stakeholders meeting, 4/10/2022, Florence, Italy, (2022)

WP20 Regulatory. Workshop outcome, dissemination, gaps, and next steps: from models to showcases, Van Molle, Wim , 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., Bekeredjian-Ding, Isabelle, Trouvin Jean-Hugues, Depraetere Hilde, La Carine, Suvarnapunya Akamol E., Bell Alan, Mann Alex, Meij Pauline, Bethony Jeffrey M., Schellhaas Linda, et al. , Biologicals, 2021 Nov, Volume 74, (2021)

Evaluation of the quality, safety and efficacy of RNA-based prophylactic vaccines for infectious diseases: regulatory considerations, Tesolin, L., Van Molle Wim, and Brusselmans Koen , (2021)

The Role of EDQM and OMCLs, Van Molle, Wim , Responsable des affaires réglementaires, 13/01/2021, Issue Culture in vivo ASBL, (2021)

Round table discussion, Van Molle, Wim , 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., Van Molle, Wim , 2020 PDA EUROPE - Driving Biopharmaceutical Innovations & Sustainability BioManufacturing, 22/09/2020, (2020)

Guidelines on the quality, safety and efficacy of respiratory syncytial virus vaccines, Van Molle, Wim , 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., Bekeredjian-Ding, Isabelle, Van Molle Wim, Baay Marc, and Neels Pieter , Biologicals, 2020 Jul, Volume 66, (2020)

Panel discussion on CMC in 'Risk- based strategies to support current health emergency, Van Molle, Wim , World Vaccine Conference (EU) , 20/10/2020, Web based, (2020)

Panel discussion on IABS Webinar on CHIM and COVID19, Van Molle, Wim , SARS CoV-2 CHIM Webinar, 23/06/2020, Issue IABS, (2020)

The Role of EDQM and OMCLs, Van Molle, Wim , Responsable des affaires réglementaires, 13/01/2020, Issue Culture in vivo ASBL, (2020)

Adjuvants for vaccines, A need for quality time ?, Van Molle, Wim , 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., Van Molle, Wim , 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,, Van Molle, Wim , COST regulatory workshop on adjuvants, 09/2019, (2019)

O-acetyl content testing in meningoccocal vaccine from an OMCL perspective, Tesolin, L., and Van Molle Wim , OMCL annual meeting, (2019)

Scientific &  organizing committee and Chair, Van Molle, Wim , Focus on Quality Requirements for Challenge Agents, 22/10/2019, Issue IABS, (2019)

The Role of EDQM and OMCLs, Van Molle, Wim , Responsable des affaires réglementaires , 18/12/2018, Issue Culture in vivo ASBL, (2018)

The Role of EDQM and OMCLs, Van Molle, Wim , Responsable des affaires réglementaires, 15/01/2018, Issue Culture in vivo ASBL, (2018)

Appoaching EMA and National regulatory authorties: who, when and how., Van Molle, Wim , 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, Van Molle, Wim , 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, Van Molle, Wim , OMCL Annual Meeting, 2017, Issue EDQM, Budapest, Hungary, (2017)

Panel discussion on CMC for vaccines: "Responding in Time: Dealing with Predictable and Unpredictable", Van Molle, Wim , 2017 Vaccines Bioprocess Development & Commercialization Workshop, 2017, Issue MIT Center for Biomedical Innovation (CBI), Cambrdige, MA, USA, (2017)

Panel discussion on specifications for biologicals, Van Molle, Wim , 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, Tesolin, L., and Van Molle Wim , 2017, Brussels, Belgium, p.59, (2017)

The Role of EDQM and OMCLs, Van Molle, Wim , 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., Van Molle, Wim , 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, Van Molle, Wim , WHO GLO Evaluation of quality and non-clinical data for licensing of vaccines, 2016, Issue WHO, Athens, Greece, (2016)

Evaluation of quality and non-clinical data for licencing of vaccines, Van Molle, Wim , WHO GLO product evaluation course, 29/2/2016, Issue WHO, Antalya, Turkey, (2016)

The Role of EDQM and OMCLs, Van Molle, Wim , Training  « Responsable des affaires réglementaires ", 19/1/2016, Issue In Vivo, Nivelles, Belgium, (2016)

Batch release of vaccines in Europe: from method transfer to first commercial batch available on the market. Straightforward approach that requires a proactive mind-set of the manufacturer., Van Molle, Wim, Tesolin L., Brusselmans Koen, and Waeterloos Geneviève , PDA Europe Conference Vaccines. Featuring WHO on Challenges in Vaccines Supply to Developing Countries, 0/11/2015, Issue PDA Europe, Berlin, Germany, (2015)

The Biological Standardisation activities at the international level, Van Molle, Wim , Quality control and batch release of vaccines and blood products in Europe, 0/0/2015, Issue WIV-ISP, Brussels, Belgium, (2015)

Evaluation of quality and clinical data for licencing of vaccines, Van Molle, Wim , Workshop on Advanced CTD evaluation for vaccines , 0/0/2015, Issue WHO, Teheran, Iran, (2015)

The Key to success in R&D :  Into the minds of the Quality Assessors, Van Molle, Wim , Biological Production Forum 2015, 0/0/2015, Issue WTG Events, Düsseldorf, Germany, (2015)

Panel discussion on quality by design, Van Molle, Wim , PDA Europe Conference Vaccines. Featuring WHO on Challenges in Vaccines Supply to Developing Countries, 1/12/2015, Issue PDA Europe, Berlin, Germany, (2015)

Quality Control of polysaccharide Vaccines by the Belgian National Control Lab (OMCL) in the European Batch Release Framework : Activity Report 2014, Tesolin, L., and Van Molle Wim , 2015, Brussels, Belgium, p.73, (2015)

Regulatory panel discussion. An interactive panel discussion with key authoritative figures from various European regulatory agencies focusing on the regulation of the biologics industry., Van Molle, Wim , Biological Production Forum 2015, 2015, Issue WTG Events, Düsseldorf, Germany, (2015)

Regulatory Position on Specification Settings, Van Molle, Wim , PDA Europe Conference Vaccines. Featuring WHO on Challenges in Vaccines Supply to Developing Countries, 0/12/2015, Issue PDA Europe, Berlin, Germany, (2015)

Round table discussion on posters: comparability and testing challenges, Van Molle, Wim , PDA Europe Conference Vaccines. Featuring WHO on Challenges in Vaccines Supply to Developing Countries,, 30/11/2015, Issue PDA Europe, Berlin, Germany, (2015)

Testing of expired Synflorix bulks: actions taken by three OMCLs and concerns raised by another OMCL., Van Molle, Wim , Annual OMCL meeting, 0/0/2015, Issue EDQM, Brussels, Belgium, (2015)

Vaxelis (PR5I): another fully liquid hexavalent vaccine on the EU market in 2016., Van Molle, Wim , Annual OMCL meeting, 0/0/2015, Issue EDQM, Brussels, Belgium, (2015)

Evaluation of quality and non-clinical data for licencing of vaccines, Van Molle, Wim , WHO GLO product evaluation course, 2014, Issue WHO, Tunis, Tunesia, (2014)

Quality Control of Polysaccharide Vaccines by the Belgian National Control Lab (OMCL) in the European Batch Release Framework : Activity Report 2013, Tesolin, L., and Van Molle Wim , 2014, Brussels, Belgium, p.74, (2014)

European accreditation bodies require the OMCL participation in proficiency studies independently of the performance of blind testing: a trend or a reality, Waeterloos, Geneviève, and Van Molle Wim , Annual OMCL meeting, 12/6/2013, Issue EDQM, NA, (2013)

Evaluation of quality and non-clinical data for licencing of vaccines, Van Molle, Wim , WHO GLO product evaluation course, 0/0/2013, Issue WHO, NA, (2013)

Hexacima: a fully liquid hexavalent vaccine (soon) on the market, Van Molle, Wim , Annual OMCL meeting, 13/6/2013, Issue EDQM, Helsinki, Finnland, (2013)

Possible presence of particles in MMR vaccines detected by Egyptian OMCL resolved by interaction with Belgian OMCL and manufacture, Van Molle, Wim , Annual OMCL Meeting, 11/6/2013, Issue EDQM, Helsinki, Finnland, (2013)

Quality control of polysaccharide vaccines by the Belgian National Control Lab (OMCL) in the European batch release framework: activity report 2012., Tesolin, L., and Van Molle Wim , 0/10/2013, Brussels, Belgium, p.49, (2013)

Regulatory issues regarding manufacture and control of vaccine adjuvants. The EU situation., Van Molle, Wim, Brusselmans Koen, Tesolin L., and Waeterloos Geneviève , Modern Vaccines/adjuvants Formulation: Impact On Future Development, 17/5/2013, Issue Herriot,J.,  Vanden Bossche,G., Lausanne, Switserland, (2013)

Release testing by manufacturers & Ph.Eur. compliance: lessons learnt for competent authorities. A case study: the Extractable Volume, Van Molle, Wim, and Waeterloos Geneviève , Annual OMCL meeting, 13/6/2012, Issue EDQM, NA, (2012)

Implementation over the past 20 years of the 3R's principle for batch release at the Scientific Institute of Public Health, Belgium (IPH)., Van Molle, Wim, Maes A., Ribaucour F, and Waeterloos Geneviève , Quality of medicines in a globalised world: dreams and reality, 15/10/2010, Issue European Directorate for the Quality of Medicines & HealthCare (EDQM),Council of Europe, Number 99, Prague, Czech Republic, p.98 - 99, (2010)

Testing and release of Synflorix ®  monovalent conjugated bulks: update after 1 year of a complex vaccine with complex testing, Van Molle, Wim , Annual OMCL meeting, 2010, Issue EDQM, Split, Croatia, (2010)

Implementation of Synflorix® monovalent bulk testing, Van Molle, Wim , Annual OMCL meeting, 2009, Issue EDQM, Vienna, Austria, (2009)