HORIZON EUROPE
Europeo
Specific Challenge:Reproducibility and relevance of research findings represent the pillars of the scientific method. For drug development, robust data and scientific rigor are key drivers for decision making, determining patent strength, time-to-market and consequently availability of new treatments to patients. Substantial evidence has accumulated that robustness, rigor and validity of research data can be problematic. While the issues at hand concern all areas of Research & Development, the impact of unreliable data, as well as the potential benefit of intervention, is greatest in areas already facing additional challenges, such as Neuroscience.
Scope:Starting with a first pilot project focused on Neuroscience and Safety, the goal is to advance the quality and efficiency of Discovery R&D data. This action should provide evidence/data to develop quality criteria for new and/or improved preclinical tests, develop consensus quality management recommendations in non-regulated R&D to enhance the quality of decisions made based on experimental data, and by developing an educational course on data quality as a major contributor to enhance the...
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Specific Challenge:Reproducibility and relevance of research findings represent the pillars of the scientific method. For drug development, robust data and scientific rigor are key drivers for decision making, determining patent strength, time-to-market and consequently availability of new treatments to patients. Substantial evidence has accumulated that robustness, rigor and validity of research data can be problematic. While the issues at hand concern all areas of Research & Development, the impact of unreliable data, as well as the potential benefit of intervention, is greatest in areas already facing additional challenges, such as Neuroscience.
Scope:Starting with a first pilot project focused on Neuroscience and Safety, the goal is to advance the quality and efficiency of Discovery R&D data. This action should provide evidence/data to develop quality criteria for new and/or improved preclinical tests, develop consensus quality management recommendations in non-regulated R&D to enhance the quality of decisions made based on experimental data, and by developing an educational course on data quality as a major contributor to enhance the quality culture in preclinical research. The action should also contribute to the development of a proficiency test system (ring tests) in preclinical research and to the implementation and testing of the quality principles developed by the consortium in day-to-day research settings, both in academia and industry, to achieve maximal cross fertilization and cultural exchange.
Expected Impact:These efforts can be expected to result in an improvement in the data quality of pre-clinical studies via the delivery of reliable and reproducible models with harmonized and standardized protocols and procedures. There will also be a significant contribution to the 3Rs (replacement, reduction and refinement) in the use of experimental animals in preclinical research, to IP protection and regulatory success by ensuring validity and traceability of data. Through dissemination of the scientific quality principles a cultural change and ripple effect should be triggered. Accreditation, consensus quality management recommendations, and an education module on data quality will further facilitate the implementation of innovation from academia and SMEs into the R&D process and will obviate the need for duplicate assessment of external partners.
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Características del consorcio
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La ayuda es de ámbito europeo, puede aplicar a esta linea cualquier empresa que forme parte de la Comunidad Europea.
Características del Proyecto
Los costes de personal subvencionables cubren las horas de trabajo efectivo de las personas directamente dedicadas a la ejecución de la acción. Los propietarios de pequeñas y medianas empresas que no perciban salario y otras personas físicas que no perciban salario podrán imputar los costes de personal sobre la base de una escala de costes unitarios
Los otros costes directos se dividen en los siguientes apartados: Viajes, amortizaciones, equipamiento y otros bienes y servicios. Se financia la amortización de equipos, permitiendo incluir la amortización de equipos adquiridos antes del proyecto si se registra durante su ejecución. En el apartado de otros bienes y servicios se incluyen los diferentes bienes y servicios comprados por los beneficiarios a proveedores externos para poder llevar a cabo sus tareas
La subcontratación en ayudas europeas no debe tratarse del core de actividades de I+D del proyecto. El contratista debe ser seleccionado por el beneficiario de acuerdo con el principio de mejor relación calidad-precio bajo las condiciones de transparencia e igualdad (en ningún caso consistirá en solicitar menos de 3 ofertas). En el caso de entidades públicas, para la subcontratación se deberán de seguir las leyes que rijan en el país al que pertenezca el contratante
Características de la financiación
You can access the description of the different topics in the IMI2 Call 9 topics text
The budget breakdown for this Call is given at the end of the Call topics text, in the Call Conditions section (starting page 61), as well as the following information :
List of countries and applicable rules for funding
Eligibility and admissibility conditions
Evaluation criteria and procedure, scoring and threshold: described in the Manual for submission, evaluation and grant award
Indicative timetable for evaluation and grant agreement
Provisions, proposal templates and evaluation forms for the type of action under this topic:
IMI2 Research and Innovation Action (IMI2-RIA) and (IMI2-IA):
Summary of the most relevant provisions for participating in IMI2 actions
Standard evaluation form
Proposal templates are available after entering the submission tool SOFIA.
IMI2 Model Grant Agreement
Template for Essential Clinical Trials Information
Please read carefully all provisions below before the preparation of your application !
You can access the description of the different topics in the IMI2 Call 9 topics text
The budget breakdown for this Call is given at the end of the Call topics text, in the Call Conditions section (starting page 61), as well as the following information :
List of countries and applicable rules for funding
Eligibility and admissibility conditions
Evaluation criteria and procedure, scoring and threshold: described in the Manual for submission, evaluation and grant award
Indicative timetable for evaluation and grant agreement
Provisions, proposal templates and evaluation forms for the type of action under this topic:
IMI2 Research and Innovation Action (IMI2-RIA) and (IMI2-IA):
Summary of the most relevant provisions for participating in IMI2 actions
Standard evaluation form
Proposal templates are available after entering the submission tool SOFIA.
IMI2 Model Grant Agreement
Template for Essential Clinical Trials Information
Información adicional de la convocatoria
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