27 de June, 2023
16 de January, 2024
11:59 PM
Accelerating the implementation of New Approach Methodologies and other innovative non-animal approaches for the development, testing and production of health technologies-HORIZON-JU-IHI-2023-05-01
Investigación / Innovación
Escuela de Medicina y Ciencias de la Salud - Facultad de Ciencias Naturales
Comisión Europea
10 000 000-12 000 000 EUR
The work supported under this topic seeks to pursue the aims of Directive 2010/63/EU1 on the protection of animals used for scientific purposes. It also contributes to the implementation of the 3Rs principles to “replace, reduce and refine the use of animals”, and ultimately helps progress towards no use of animals or animal-sourced materials in research, innovation and development, which is an expectation of society.
ExpectedOutcome:
1,Research and innovation (R&I) actions (projects) to be supported under this topic must contribute to all the following outcomes.
2,Researchers will benefit from the implementation of NAMs and other innovative non-animal approaches which have been assessed and validated for their performance and found to be relevant, reproducible, predictive, and standardised, ultimately leading, as relevant, to their regulatory acceptance for use in infectious and/or non-communicable disease applications. The new approaches should lead to an improvement in the assessment of health technologies (and animal to human translation where relevant) and/or production processes, and to a significant reduction in the number of animals used. In addition, these approaches may answer questions that current methods cannot, and improve the predictability and robustness of evidence generated for regulatory decision-making.
3,European industry will benefit from the establishment and availability of NAMs and other innovative non‑animal approaches for the testing, development and/or production of health technologies that are fit-for-purpose to support regulatory decision making.
4,Researchers and developers of innovative healthcare solutions will have access to high-quality data, new recommendations and best practices to incentivise the use of NAMs and other non-animal approaches and their integration in industrial processes. This should be supported by an appropriate digital repository to ensure both the sustainability and scalability of the knowledge base.
5,Regulators and policy makers will gain knowledge and have access to high-quality data on the characteristics and use of NAMs and other innovative non-animal approaches in the production and development of health technologies to foster the development of harmonised guidance and requirements, as well as uptake or translation into health policies.
Expected Impact:
The work supported under this topic seeks to pursue the aims of Directive 2010/63/EU1 on the protection of animals used for scientific purposes. It also contributes to the implementation of the 3Rs principles to “replace, reduce and refine the use of animals”, and ultimately helps progress towards no use of animals or animal-sourced materials in research, innovation and development, which is an expectation of society.
The following impacts are expected.
•Break down silos between technological areas and disciplines, and bring together different stakeholders (e.g. health industry, academia, small and medium-sized enterprises (SMEs), patients, regulators, non‑governmental organisations (NGOs) and policy makers) to foster the use of new approach methodologies2 (NAMs) and other non-animal approaches in the efficient development, testing and production of safe and effective innovative health technologies3 (e.g. medicinal products, medical devices, biopharmaceuticals, vaccines, in vitro diagnostics) and their combinations.
•Improve public health as patients will benefit faster from safe and effective health technologies developed using NAMs and other non-animal approaches that, where relevant, provide more human-relevant data and are more predictive than current approaches.
•Foster the development of health policies and standards on the use of NAMs and other non-animal approaches in health technologies which will positively affect public health.
Enhance the competitiveness of the European health industry that will benefit from high quality innovative approaches and methodologies for the development and production of new health technologies, which can reduce the time and costs of processes while significantly reducing the use of animals or animal-sourced biomaterials.
•Help to make the EU more sustainable/autonomous by achieving regulatory validation and uptake of NAMs and other non-animal approaches for the development, testing and production of health technologies that are not dependent on shortages/issues with animal supply.
Documents: (Check them on the webside).
IHI JU Evaluation form for Research and Innovation Actions (single and two-stage Calls)
IHI JU Proposal template (RIA/SP) - Part B
•Colombia is eligible as a third country, for this it must participate with the role of partner together with a consortium with at least three entities from different European/associated countries).
OBJETIVO/DESCRIPCIÓN
The work supported under this topic seeks to pursue the aims of Directive 2010/63/EU1 on the protection of animals used for scientific purposes. It also contributes to the implementation of the 3Rs principles to “replace, reduce and refine the use of animals”, and ultimately helps progress towards no use of animals or animal-sourced materials in research, innovation and development, which is an expectation of society.
REQUISITOS CLAVE
ExpectedOutcome:
1,Research and innovation (R&I) actions (projects) to be supported under this topic must contribute to all the following outcomes.
2,Researchers will benefit from the implementation of NAMs and other innovative non-animal approaches which have been assessed and validated for their performance and found to be relevant, reproducible, predictive, and standardised, ultimately leading, as relevant, to their regulatory acceptance for use in infectious and/or non-communicable disease applications. The new approaches should lead to an improvement in the assessment of health technologies (and animal to human translation where relevant) and/or production processes, and to a significant reduction in the number of animals used. In addition, these approaches may answer questions that current methods cannot, and improve the predictability and robustness of evidence generated for regulatory decision-making.
3,European industry will benefit from the establishment and availability of NAMs and other innovative non‑animal approaches for the testing, development and/or production of health technologies that are fit-for-purpose to support regulatory decision making.
4,Researchers and developers of innovative healthcare solutions will have access to high-quality data, new recommendations and best practices to incentivise the use of NAMs and other non-animal approaches and their integration in industrial processes. This should be supported by an appropriate digital repository to ensure both the sustainability and scalability of the knowledge base.
5,Regulators and policy makers will gain knowledge and have access to high-quality data on the characteristics and use of NAMs and other innovative non-animal approaches in the production and development of health technologies to foster the development of harmonised guidance and requirements, as well as uptake or translation into health policies.
Expected Impact:
The work supported under this topic seeks to pursue the aims of Directive 2010/63/EU1 on the protection of animals used for scientific purposes. It also contributes to the implementation of the 3Rs principles to “replace, reduce and refine the use of animals”, and ultimately helps progress towards no use of animals or animal-sourced materials in research, innovation and development, which is an expectation of society.
The following impacts are expected.
•Break down silos between technological areas and disciplines, and bring together different stakeholders (e.g. health industry, academia, small and medium-sized enterprises (SMEs), patients, regulators, non‑governmental organisations (NGOs) and policy makers) to foster the use of new approach methodologies2 (NAMs) and other non-animal approaches in the efficient development, testing and production of safe and effective innovative health technologies3 (e.g. medicinal products, medical devices, biopharmaceuticals, vaccines, in vitro diagnostics) and their combinations.
•Improve public health as patients will benefit faster from safe and effective health technologies developed using NAMs and other non-animal approaches that, where relevant, provide more human-relevant data and are more predictive than current approaches.
•Foster the development of health policies and standards on the use of NAMs and other non-animal approaches in health technologies which will positively affect public health.
Enhance the competitiveness of the European health industry that will benefit from high quality innovative approaches and methodologies for the development and production of new health technologies, which can reduce the time and costs of processes while significantly reducing the use of animals or animal-sourced biomaterials.
•Help to make the EU more sustainable/autonomous by achieving regulatory validation and uptake of NAMs and other non-animal approaches for the development, testing and production of health technologies that are not dependent on shortages/issues with animal supply.
Documents: (Check them on the webside).
IHI JU Evaluation form for Research and Innovation Actions (single and two-stage Calls)
IHI JU Proposal template (RIA/SP) - Part B
•Colombia is eligible as a third country, for this it must participate with the role of partner together with a consortium with at least three entities from different European/associated countries).