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PHC-33-2015
PHC-33-2015: New approaches to improve predictive human safety testing
Scope:Specific challenge: Current approaches assessing the safety of chemical substances in humans are expensive and time consuming, and may be of limited relevance as a predictor of adverse effects. Better approaches are needed both to improve the efficiency of predictive toxicological testing to address key areas of concern for human health and to meet regulatory requirements (e.g. EU legislations on REACH, cosmetics, biocides). Safety testing is of worldwide concern and therefore international cooperation may be an important element in addressing the challenge.
Sólo fondo perdido 0 €
Europeo
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Esta ayuda financia Proyectos: Objetivo del proyecto:

Scope:Specific challenge: Current approaches assessing the safety of chemical substances in humans are expensive and time consuming, and may be of limited relevance as a predictor of adverse effects. Better approaches are needed both to improve the efficiency of predictive toxicological testing to address key areas of concern for human health and to meet regulatory requirements (e.g. EU legislations on REACH, cosmetics, biocides). Safety testing is of worldwide concern and therefore international cooperation may be an important element in addressing the challenge.

 

Scope: Proposals should capitalise on advances in all relevant fields of science to understand complex biological pathways of toxicological relevance and to identify early markers predictive of toxicological effects in humans with the objectives of developing and validating routine, non-animal approaches for toxicity testing of chemical substances (excluding radio-chemicals). The research may include the development of methodologies for confirmatory testing of mechanistic hypotheses to improve understanding of toxicity mechanisms.

 

Proposals should involve, amongst ot... ver más

Scope:Specific challenge: Current approaches assessing the safety of chemical substances in humans are expensive and time consuming, and may be of limited relevance as a predictor of adverse effects. Better approaches are needed both to improve the efficiency of predictive toxicological testing to address key areas of concern for human health and to meet regulatory requirements (e.g. EU legislations on REACH, cosmetics, biocides). Safety testing is of worldwide concern and therefore international cooperation may be an important element in addressing the challenge.

 

Scope: Proposals should capitalise on advances in all relevant fields of science to understand complex biological pathways of toxicological relevance and to identify early markers predictive of toxicological effects in humans with the objectives of developing and validating routine, non-animal approaches for toxicity testing of chemical substances (excluding radio-chemicals). The research may include the development of methodologies for confirmatory testing of mechanistic hypotheses to improve understanding of toxicity mechanisms.

 

Proposals should involve, amongst others, research communities, SMEs, industry and regulatory agencies as appropriate. Proposals should demonstrate efficient mechanisms for the co-ordination of activities and exchange of information, and should include a timeline for delivery of test methods.

 

In line with the Union’s strategy for international cooperation[1] in research and innovation, cooperation is encouraged with similar initiatives in the USA and elsewhere, and would be highly beneficial from scientific and economic standpoints.

 Proposals could consider the involvement of the European Commission Joint Research Centre (JRC) as an added value in order to provide an effective interface between the research activities and regulatory aspects and/or to translate the research results into validated test methods and strategies fit for regulatory purpose. In that respect, the JRC will collaborate with any successful proposal.

 

Applicants are encouraged to seek during the life-time of the project additional support from various sectors in order to facilitate translational aspects.

 

The Commission considers that proposals requesting a contribution from the EU of between EUR 10 and 30 million would allow this specific challenge to be addressed appropriately. Nonetheless, this does not preclude submission and selection of proposals requesting other amounts.

 

Expected impact:

More effective, faster, cheaper toxicological testing to better predict human risk and meet regulatory needs. Improved toxicological knowledge to encourage ‘read across’ between chemical substances for use in different research and regulatory domains. Commercial exploitation of the developed toxicological testing methods and assessment approaches, products and services. Advancement of international co-operation in the field of predictive toxicology and human safety testing. Reduced use of laboratory animals in safety testing.  

Form of funding: Research and innovation actions

[1] COM(2012)497


Cross-cutting Priorities:International cooperation


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Temáticas Obligatorias del proyecto: Temática principal:

Características del consorcio

Ámbito Europeo : La ayuda es de ámbito europeo, puede aplicar a esta linea cualquier empresa que forme parte de la Comunidad Europea.
Tipo y tamaño de organizaciones: El diseño de consorcio necesario para la tramitación de esta ayuda necesita de:

Características del Proyecto

Requisitos de diseño: Duración:
Requisitos técnicos: Scope:Specific challenge: Current approaches assessing the safety of chemical substances in humans are expensive and time consuming, and may be of limited relevance as a predictor of adverse effects. Better approaches are needed both to improve the efficiency of predictive toxicological testing to address key areas of concern for human health and to meet regulatory requirements (e.g. EU legislations on REACH, cosmetics, biocides). Safety testing is of worldwide concern and therefore international cooperation may be an important element in addressing the challenge. Scope:Specific challenge: Current approaches assessing the safety of chemical substances in humans are expensive and time consuming, and may be of limited relevance as a predictor of adverse effects. Better approaches are needed both to improve the efficiency of predictive toxicological testing to address key areas of concern for human health and to meet regulatory requirements (e.g. EU legislations on REACH, cosmetics, biocides). Safety testing is of worldwide concern and therefore international cooperation may be an important element in addressing the challenge.
¿Quieres ejemplos? Puedes consultar aquí los últimos proyectos conocidos financiados por esta línea, sus tecnologías, sus presupuestos y sus compañías.
Capítulos financiables: Los capítulos de gastos financiables para esta línea son:
Personnel costs.
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
Purchase costs.
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
Subcontracting costs.
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
Amortizaciones.
Activos.
Otros Gastos.
Madurez tecnológica: La tramitación de esta ayuda requiere de un nivel tecnológico mínimo en el proyecto de TRL 5:. Los elementos básicos de la innovación son integrados de manera que la configuración final es similar a su aplicación final, es decir que está listo para ser usado en la simulación de un entorno real. Se mejoran los modelos tanto técnicos como económicos del diseño inicial, se ha identificado adicionalmente aspectos de seguridad, limitaciones ambiéntales y/o regulatorios entre otros. + info.
TRL esperado:

Características de la financiación

Intensidad de la ayuda: Sólo fondo perdido + info
Fondo perdido:
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Please read carefully all provisions below before the preparation of your application.
The budget breakdown for this call is given in the call conditions section of the work programme. [,ADD hyprelink]:
List of countries and applicable rules for funding: described in part A of the General Annexes of the General Work Programme.
 
Eligibility and admissibility conditions: described in part B and C of the General Annexes of the General Work Programme
 
Evaluation
3.1  Evaluation criteria and procedure, scoring and threshold: described in part H of the General Annexes of the General Work Programme with the following exceptions:
- The thresholds for each criterion in a single stage process will be 4, 4 and 3. The cumulative threshold will be 12.
- If a proposal fails to achieve the threshold for a criterion at any stage, the evaluation of the proposal will be stopped.
- For the evaluation of topics PHC33 – 2015, the Commission will organise hearings at stage 1 with applicants as part of the panel deliberations for all proposals above threshold.
3.2 Guide to the submission and evaluation process
 
Proposal page limits and layout: Please refer to Part B of the standard proposal template.
 
Indicative timetable for evaluation and grant agreement:
Information on the outcome of one-stage evaluation: maximum 5 months from the final date for submission...
Please read carefully all provisions below before the preparation of your application.
The budget breakdown for this call is given in the call conditions section of the work programme. [,ADD hyprelink]:
List of countries and applicable rules for funding: described in part A of the General Annexes of the General Work Programme.
 
Eligibility and admissibility conditions: described in part B and C of the General Annexes of the General Work Programme
 
Evaluation
3.1  Evaluation criteria and procedure, scoring and threshold: described in part H of the General Annexes of the General Work Programme with the following exceptions:
- The thresholds for each criterion in a single stage process will be 4, 4 and 3. The cumulative threshold will be 12.
- If a proposal fails to achieve the threshold for a criterion at any stage, the evaluation of the proposal will be stopped.
- For the evaluation of topics PHC33 – 2015, the Commission will organise hearings at stage 1 with applicants as part of the panel deliberations for all proposals above threshold.
3.2 Guide to the submission and evaluation process
 
Proposal page limits and layout: Please refer to Part B of the standard proposal template.
 
Indicative timetable for evaluation and grant agreement:
Information on the outcome of one-stage evaluation: maximum 5 months from the final date for submission.
Signature of grant agreements: maximum 3 months from the date of informing successful applicants.
 
Provisions, proposal templates and evaluation forms for the type(s) of action(s) under this topic:
Research and Innovation Action:
Specific provisions and funding rates
Standard proposal template (administrative forms and structure of technical annex)
Annotated Model Grant Agreement
For information, a pdf. template of the evaluation form for this topic is available on the call page under call documents. In addition, to be consulted on the same page a specific template for essential information for clinical trials/studies/investigations is available.
 
Additional provisions:
Horizon 2020 budget flexibility
Classified information
 
Open access must be granted to all scientific publications resulting from Horizon 2020 actions, and proposals must refer to measures envisaged. Where relevant, proposals should also provide information on how the participants will manage the research data generated and/or collected during the project, such as details on what types of data the project will generate, whether and how this data will be exploited or made accessible for verification and re-use, and how it will be curated and preserved.
 
Garantías:
No exige Garantías
No existen condiciones financieras para el beneficiario.

Información adicional de la convocatoria

Efecto incentivador: Esta ayuda tiene efecto incentivador, por lo que el proyecto no puede haberse iniciado antes de la presentación de la solicitud de ayuda. + info.
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