Innovating Works
HORIZON-HLTH-2024-IND-06-09
Gaining experience and confidence in New Approach Methodologies (...
ExpectedOutcome:This topic aims at supporting activities that are enabling or contributing to one or several expected impacts of destination 6 “Maintaining an innovative, sustainable and globally competitive health industry”. To that end, proposals under this topic should aim to deliver results that are directed, tailored towards and contributing to all of the following expected outcomes:
Sólo fondo perdido 0 €
European
This call is closed This line is already closed so you can't apply. It closed last day 11-04-2024.
An upcoming call for this aid is expected, the exact start date of call is not yet clear.
Hace más de 14 mes(es) del cierre y aún no tenemos información sobre los proyectos financiados, no parece que se vaya a publicar esta información.
Presentation: Consortium Consortium: Esta ayuda está diseñada para aplicar a ella en formato consorcio.
Minimum number of participants.
This aid finances Proyectos:

ExpectedOutcome:This topic aims at supporting activities that are enabling or contributing to one or several expected impacts of destination 6 “Maintaining an innovative, sustainable and globally competitive health industry”. To that end, proposals under this topic should aim to deliver results that are directed, tailored towards and contributing to all of the following expected outcomes:

European regulators gain state-of-the-art knowledge on different NAMs that are being proposed for the assessment of the safety and efficacy of chemicals and pharmaceuticals;European regulators understand better the shortcomings of the current tools based on animal procedures for the assessment of chemicals and pharmaceuticals;European regulators collaborate on a framework on how to assess the safety of chemicals based on NAM-data and how to classify the hazardous properties based on such data;European regulators collaborate on a similar framework for assessment of safety and efficacy of pharmaceuticals based on NAM-data;Citizens benefit from the supply and use of chemicals and pharmaceuticals that have been assessed through NAMs that are better predicting potential effects in humans t... see more

ExpectedOutcome:This topic aims at supporting activities that are enabling or contributing to one or several expected impacts of destination 6 “Maintaining an innovative, sustainable and globally competitive health industry”. To that end, proposals under this topic should aim to deliver results that are directed, tailored towards and contributing to all of the following expected outcomes:

European regulators gain state-of-the-art knowledge on different NAMs that are being proposed for the assessment of the safety and efficacy of chemicals and pharmaceuticals;European regulators understand better the shortcomings of the current tools based on animal procedures for the assessment of chemicals and pharmaceuticals;European regulators collaborate on a framework on how to assess the safety of chemicals based on NAM-data and how to classify the hazardous properties based on such data;European regulators collaborate on a similar framework for assessment of safety and efficacy of pharmaceuticals based on NAM-data;Citizens benefit from the supply and use of chemicals and pharmaceuticals that have been assessed through NAMs that are better predicting potential effects in humans than the current assessment methods;Industry has an improved competitive position with the availability of harmonised and standardised NAM-based assessment tools that are faster and more flexible;European Commission and Member States regulators are responding to the societal demand to move away from animal testing.
Scope:There is increasing scientific evidence pointing to the limitations of animal testing for safety and efficacy assessment of chemicals and pharmaceuticals. Europe is also experiencing a strong societal demand to move away from animal testing. Scientific progress of the past two decades has produced a number of animal-free New Approach Methodologies (NAMs) that have the potential to be used instead of the animal models that are currently employed for such testing. However, knowledge, experience and confidence on how results from the NAM assays could be used is still lacking among regulators, which could limit the industry’s use of NAMs because of lack of legal certainty when generating safety and health data requested by EU legislation.

The proposals should focus on alternatives to the use of animals for regulatory safety and efficacy testing. Applicants should propose activities that bring together NAM developers and NAM users with European regulators responsible for the safe use of chemicals (e.g. industrial chemicals, pesticides, biocides and cosmetics) and pharmaceuticals in order to inform on NAM solutions available and to encourage the building of a framework on how these NAMs could be most effectively used in the different decision-making contexts. For NAMs applicable to chemical risk assessment, collaboration with existing initiatives such as the Partnership for the Assessment of Risks from Chemicals (PARC) and the ASPIS cluster of projects (Animal-free Safety Assessment of chemicals: Project cluster for Implementation of novel Strategies) is encouraged.

To build such a framework the proposals should address all of the following:

develop technical and regulatory readiness criteriareflect on how to provide mechanisms to support technology transfer, i.e. bringing promising NAMs to the market (including optimisation and transferability assessment)discuss how to standardise NAMs and NAM-based strategies via OECD, CEN, ISO, ICH, VICH and other international organisations, as applicableprovide technical training for Contract Research Organisations (CROs) applying NAMs for regulatory purposespromote dialogue (involving companies, regulatory bodies on EU level, including ECHA, EMA and EFSA and Member States authorities) on how to integrate and interpret data from NAMs and facilitate their uptake for safety and efficacy testing of chemicals (including pesticides) and pharmaceuticals, while addressing the lack of reliability and shortcomings of the current tools based on animal proceduresidentify obstacles in EU legislation for the regulatory use of NAMs and propose options/changes in the EU regulatory framework which address these obstacles and facilitate the uptake and use of NAMs Proposals should consider involving the JRC to take advantage of its expertise and relevant activities in bridging research and regulatory communities and facilitating uptake of NAMs for regulatory application. In that respect, the JRC is open to collaborate with any successful proposal after its approval.


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Temáticas Obligatorias del proyecto: Temática principal:
This topic focuses on transitioning from animal testing to New Approach Methodologies (NAMs) for assessing chemical and pharmaceutical safety and efficacy. The goal is for European regulators to adopt NAM-based tools, improving industry competitiveness, meeting societal demands, and enhancing regulatory frameworks to support NAM adoption and implementation. This topic focuses on transitioning from animal testing to New Approach Methodologies (NAMs) for assessing chemical and pharmaceutical safety and efficacy. The goal is for European regulators to adopt NAM-based tools, improving industry competitiveness, meeting societal demands, and enhancing regulatory frameworks to support NAM adoption and implementation.
Pharmacokinetics Translational medicine Pharmacology pharmacogenomics drug discovery and Toxicology Medical biotechnology Pharmacodynamics New Approach Methodologies (NAMs) safety efficacy chemicals pharmaceuticals regulators animal testing pharmaceutical assessment harmonised standardised competitive position flexibility societal demand scientific evidence limitations regulatory safety efficacy European Commission Member States assessment tools flexibility regulatory framework societal demand animal models decision-making contexts chemical risk assessment technology transfer standardisation technical training Contract Research Organisations (CROs) reliability EU legislation regulatory framework obstacles JRC expertise regulatory application. Drug discovery Chemical safety Pharmaceutical safety Regulatory frameworks New Approach Methodologies (NAMs) Adoption Regulatory Framework Enhancement Chemical and Pharmaceutical Safety Assessment pharmacogenomics drug discovery safety efficacy chemicals pharmaceuticals regulators animal testing pharmaceutical assessment harmonised standardised competitive position flexibility societal demand scientific evidence limitations regulatory safety European Commission Member States assessment tools regulatory framework animal models decision-making contexts chemical risk assessment technology transfer standardisation technical training Contract Research Organisations (CROs) reliability EU legislation obstacles JRC expertise regulatory application

Consortium characteristics

Scope European : The aid is European, you can apply to this line any company that is part of the European Community.
Tipo y tamaño de organizaciones: The necessary consortium design for the processing of this aid needs:

characteristics of the Proyecto

Requisitos de diseño por participante: *Presupuesto para cada participante en el proyecto
Requisitos técnicos: The expected impacts of the project include: 1. Equipping European regulators with advanced knowledge on New Approach Methodologies (NAMs) for chemicals and pharmaceutical assessments 2. Enhancing regulators' understanding of NAM-based safety evaluation and classification frameworks 3. Ensuring citizens benefit from improved chemical and pharmaceutical assessment accuracy 4. Strengthening industry competitiveness with standardized NAM tools 5. Addressing societal demands for reduced animal testing by regulators and the European Commission. The expected impacts of the project include:
1. Equipping European regulators with advanced knowledge on New Approach Methodologies (NAMs) for chemicals and pharmaceutical assessments
2. Enhancing regulators' understanding of NAM-based safety evaluation and classification frameworks
3. Ensuring citizens benefit from improved chemical and pharmaceutical assessment accuracy
4. Strengthening industry competitiveness with standardized NAM tools
5. Addressing societal demands for reduced animal testing by regulators and the European Commission.
Financial Chapters: The chapters of financing expenses for this line are:
Personnel costs.
Expenses related to personnel working directly on the project are based on actual hours spent, based on company costs, and fixed ratios for certain employees, such as the company's owners.
Subcontracting costs.
Payments to external third parties to perform specific tasks that cannot be performed by the project beneficiaries.
Purchase costs.
They include the acquisition of equipment, amortization, material, licenses or other goods and services necessary for the execution of the project
Other cost categories.
Miscellaneous expenses such as financial costs, audit certificates or participation in events not covered by other categories
Indirect costs.
Overhead costs not directly assignable to the project (such as electricity, rent, or office space), calculated as a fixed 25% of eligible direct costs (excluding subcontracting).
Madurez tecnológica: The processing of this aid requires a minimum technological level in the project of TRL 9:. En esta fase la innovación está en su fase final y es operable en un sin número de condiciones operativas, está probada y disponible para su comercialización y/o producción disponible para la sociedad. Entrega de producto o tecnología para producción en serie y comercialización. + info.
TRL esperado:

Characteristics of financing

Intensidad de la ayuda: Sólo fondo perdido + info
Lost Fund:
For the eligible budget, the intensity of the aid in the form of a lost fund may reach as minimum a 100%.
The funding rate for CSA projects is 100 % of the eligible costs for all types of organizations. The funding rate for CSA projects is 100 % of the eligible costs for all types of organizations.
Guarantees:
does not require guarantees
No existen condiciones financieras para el beneficiario.

Additional information about the call

incentive effect: Esta ayuda no tiene efecto incentivador. + info.
Respuesta Organismo: Se calcula que aproximadamente, la respuesta del organismo una vez tramitada la ayuda es de:
Meses de respuesta:
Muy Competitiva:
non -competitive competitive Very competitive
We do not know the total budget of the line
Financial Projects In this call.
minimis: Esta línea de financiación NO considera una “ayuda de minimis”. You can consult the regulations here.
Certificado DNSH: Los proyectos presentados a esta línea deben de certificarse para demostrar que no causan perjuicio al medio ambiente. + info

other advantages

SME seal: Tramitar esta ayuda con éxito permite conseguir el sello de calidad de “sello pyme innovadora”. Que permite ciertas ventajas fiscales.
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HORIZON-HLTH-2024-IND-06-09 Gaining experience and confidence in New Approach Methodologies (NAM) for regulatory safety and efficacy testing – coordinated training and experience exchange for regulators
en consorcio: ExpectedOutcome:This topic aims at supporting activities that are enabling or contributing to one or several expected impacts of destination...
Cerrada does 1 year | next call scheduled for the month of