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Report of the First ONTOX Stakeholder Network Meeting: Digging Under the Surface of ONTOX Together With the Stakeholders.
Diemar, Michael G; Vinken, Mathieu; Teunis, Marc; Krul, Cyrille A M; Busquet, Francois; Zajac, Julia Dominika; Kandarova, Helena; Corvi, Raffaella; Rosso, Matteo Z; Kharina, Anastasiia; Bryndum, Louise Stab; Santillo, Michael; Bloch, Denise; Kucheryavenko, Olena; Panagiotakos, Demosthenes; Rogiers, Vera; Beekhuijzen, Manon; Giusti, Arianna; Najjar, Abdulkarim; Courage, Carol; Koenig, Torben; Kolle, Susanne; Boonen, Harrie; Dhalluin, Stephane; Boberg, Julie; Müller, Boris P; Kukic, Predrag; Ritskes-Hoitinga, Merel; Grasselli, Elena; Zietek, Tamara; Stoddart, Gilly; Heusinkveld, Harm J; Castell, Jose V; Benfenati, Emilio; Yang, Huan; Perera, Simón; Paini, Alicia; Kramer, Nynke I; Hartung, Thomas; Janssen, Manoe; Fritsche, Ellen; Jennen, Danyel G J; Piumatti, Matteo; Rathman, James; Marusczyk, Jörg; Milec, Lucia; Roggen, Erwin L.
Afiliación
  • Diemar MG; 3Rs Management and Consulting ApS, Kongens Lyngby, Denmark.
  • Vinken M; Department of Pharmaceutical and Pharmacological Sciences, Vrije Universiteit Brussel, Brussel, Belgium.
  • Teunis M; Innovative Testing in Life Sciences & Chemistry, University of Applied Sciences, Utrecht, The Netherlands.
  • Krul CAM; Innovative Testing in Life Sciences & Chemistry, University of Applied Sciences, Utrecht, The Netherlands.
  • Busquet F; Altertox, Ixelles, Belgium.
  • Zajac JD; Department of Pharmaceutical and Pharmacological Sciences, Vrije Universiteit Brussel, Brussel, Belgium.
  • Kandarova H; Institute of Experimental Pharmacology and Toxicology, Centre of Experimental Medicine, Slovak Academy of Sciences, Bratislava, Slovakia.
  • Corvi R; European Commission, Joint Research Centre (JRC), Ispra, Italy.
  • Rosso MZ; Angel Consulting S.a.S., Genova, Italy.
  • Kharina A; Angel Consulting S.a.S., Genova, Italy.
  • Bryndum LS; Danish Environmental Protection Agency, Copenhagen, Denmark.
  • Santillo M; Center for Food Safety and Applied Nutrition (CFSAN), US Food and Drug Administration (FDA), Laurel, MD, USA.
  • Bloch D; Department of Pesticides Safety, German Federal Institute for Risk Assessment (BfR), Berlin, Germany.
  • Kucheryavenko O; Department of Chemicals and Product Safety, German Federal Institute for Risk Assessment (BfR), Berlin, Germany.
  • Panagiotakos D; SCHEER/EC-Scientific Committee on Health, Environmental and Emerging Risks/European Commission, European Commission, Brussels, Belgium.
  • Rogiers V; Department of Pharmaceutical and Pharmacological Sciences, Vrije Universiteit Brussel, Brussel, Belgium.
  • Beekhuijzen M; SCCS-Scientific Committee on Consumer Safety, European Commission, Brussels, Belgium.
  • Giusti A; Charles River Laboratories, 's-Hertogenbosch, The Netherlands.
  • Najjar A; Cosmetics Europe-The Personal Care Association, Brussels, Belgium.
  • Courage C; Beiersdorf AG, Hamburg, Germany.
  • Koenig T; International Collaboration on Cosmetics Safety (ICCS), Mt Royal, NJ, USA.
  • Kolle S; International Collaboration on Cosmetics Safety (ICCS), Mt Royal, NJ, USA.
  • Boonen H; International Collaboration on Cosmetics Safety (ICCS), Mt Royal, NJ, USA.
  • Dhalluin S; Experimental Toxicology and Ecology, BASF SE, Ludwigshafen am Rhein, Germany (for CEFIC).
  • Boberg J; H. Lundbeck, Valby, Denmark.
  • Müller BP; L'Oreal, Paris, France.
  • Kukic P; Novo Nordisk, Bagsværd, Denmark.
  • Ritskes-Hoitinga M; Symrise AG, Holzminden, Germany.
  • Grasselli E; Safety & Environmental Assurance Centre, Unilever, Bedfordshire, UK.
  • Zietek T; Institute for Risk Assessment Sciences Toxicology, Faculty of Veterinary Medicine, Utrecht University, Utrecht, The Netherlands.
  • Stoddart G; Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.
  • Heusinkveld HJ; Department of Earth, Environment, and Life Science, University of Genoa, Genova, Italy.
  • Castell JV; Interuniversity Center for the Promotion of 3R Principles in Teaching and Research (Centro 3R), Pisa, Italy.
  • Benfenati E; Doctors Against Animal Experiments, Cologne, Germany.
  • Yang H; PETA Science Consortium International e.V., Stuttgart, Germany.
  • Perera S; Dutch National Institute for Public Health and the Environment, Centre for Health Protection, Bilthoven, The Netherlands.
  • Paini A; Department of Biochemistry, IIS Hospital La Fe and CIBERHED, University of Valencia, Valencia, Spain.
  • Kramer NI; Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milano, Italy.
  • Hartung T; esqLABS GmbH, Saterland, Germany.
  • Janssen M; ProtoQSAR SL, Centro Europeo de Empresas Innovadoras, Paterna, Spain.
  • Fritsche E; Departament de Medicina i Ciències de la Vida, Institut de Biologia Evolutiva (CSIC-UPF), Universitat Pompeu Fabra, Barcelona, Spain.
  • Jennen DGJ; esqLABS GmbH, Saterland, Germany.
  • Piumatti M; Toxicology Chair Group, Wageningen University, Wageningen, The Netherlands.
  • Rathman J; Center for Alternatives to Animal Testing Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, USA.
  • Marusczyk J; The Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, The Netherlands.
  • Milec L; IUF-Leibniz Research Institute for Environmental Medicine, Düsseldorf, Germany.
  • Roggen EL; Medical Faculty, Heinrich-Heine-University, Düsseldorf, Germany.
Altern Lab Anim ; 52(2): 117-131, 2024 Mar.
Article en En | MEDLINE | ID: mdl-38235727
ABSTRACT
The first Stakeholder Network Meeting of the EU Horizon 2020-funded ONTOX project was held on 13-14 March 2023, in Brussels, Belgium. The discussion centred around identifying specific challenges, barriers and drivers in relation to the implementation of non-animal new approach methodologies (NAMs) and probabilistic risk assessment (PRA), in order to help address the issues and rank them according to their associated level of difficulty. ONTOX aims to advance the assessment of chemical risk to humans, without the use of animal testing, by developing non-animal NAMs and PRA in line with 21st century toxicity testing principles. Stakeholder groups (regulatory authorities, companies, academia, non-governmental organisations) were identified and invited to participate in a meeting and a survey, by which their current position in relation to the implementation of NAMs and PRA was ascertained, as well as specific challenges and drivers highlighted. The survey analysis revealed areas of agreement and disagreement among stakeholders on topics such as capacity building, sustainability, regulatory acceptance, validation of adverse outcome pathways, acceptance of artificial intelligence (AI) in risk assessment, and guaranteeing consumer safety. The stakeholder network meeting resulted in the identification of barriers, drivers and specific challenges that need to be addressed. Breakout groups discussed topics such as hazard versus risk assessment, future reliance on AI and machine learning, regulatory requirements for industry and sustainability of the ONTOX Hub platform. The outputs from these discussions provided insights for overcoming barriers and leveraging drivers for implementing NAMs and PRA. It was concluded that there is a continued need for stakeholder engagement, including the organisation of a 'hackathon' to tackle challenges, to ensure the successful implementation of NAMs and PRA in chemical risk assessment.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Inteligencia Artificial / Rutas de Resultados Adversos Tipo de estudio: Risk_factors_studies Límite: Animals / Humans País/Región como asunto: Europa Idioma: En Revista: Altern Lab Anim Año: 2024 Tipo del documento: Article País de afiliación: Dinamarca Pais de publicación: Reino Unido
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Inteligencia Artificial / Rutas de Resultados Adversos Tipo de estudio: Risk_factors_studies Límite: Animals / Humans País/Región como asunto: Europa Idioma: En Revista: Altern Lab Anim Año: 2024 Tipo del documento: Article País de afiliación: Dinamarca Pais de publicación: Reino Unido