HORIZON EUROPE
Europeo
Specific Challenge:Efficient and adequate safety assessment remains one of the main challenges in the drug discovery, development and submission process. Recent advances have shown that sharing of public & private pre-clinical data is achievable. In parallel, the electronic CDISC-SEND format has been chosen for file submission to the FDA. This offers the opportunity to generate and exploit a large amount of organised data to allow the in-depth assessment of the preclinical species predictivity to human.
Scope:The NexGETS project will:
Development of an internationally accepted guideline for data sharing Accrue large sets of d preclinical and high-level clinical safety data Conduct a retrospective data analysis to assess translation of preclinical to clinical safety outcomes Ensure that participating companies have similar or greater access to data as regulators to facilitate discussion Develop innovative tools for data mining, analysis, data display and prediction
Expected Impact:The NexGETS project should aim to set world standards and act as the central partner to go to in terms of preclinical data handling, analysis and use f...
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Specific Challenge:Efficient and adequate safety assessment remains one of the main challenges in the drug discovery, development and submission process. Recent advances have shown that sharing of public & private pre-clinical data is achievable. In parallel, the electronic CDISC-SEND format has been chosen for file submission to the FDA. This offers the opportunity to generate and exploit a large amount of organised data to allow the in-depth assessment of the preclinical species predictivity to human.
Scope:The NexGETS project will:
Development of an internationally accepted guideline for data sharing Accrue large sets of d preclinical and high-level clinical safety data Conduct a retrospective data analysis to assess translation of preclinical to clinical safety outcomes Ensure that participating companies have similar or greater access to data as regulators to facilitate discussion Develop innovative tools for data mining, analysis, data display and prediction
Expected Impact:The NexGETS project should aim to set world standards and act as the central partner to go to in terms of preclinical data handling, analysis and use for predictive toxicology
This approach will have an impact on the 3Rs
The same cause has also an incidence on the attrition rate which should logically equally improve overall.
This approach should also reduce the length of development before reaching patients.
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Características del consorcio
:
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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