HORIZON EUROPE
Europeo
Specific Challenge:Pharmaceuticals are present in the environment as a consequence of patient use, manufacture, and improper disposal. They predominantly enter the aquatic environment via patient use. In the European Union (EU) an environmental risk assessment (ERA) is required as part of the marketing application and approval for new drugs. Currently the ERA is conducted late in drug development and often parallel to Phase III clinical trials and after significant investment.
The growing regulatory and scientific concerns regarding pharmaceuticals in the environment have reached the point where some stakeholders are advocating:
the inclusion of environmental hazard and risk within the patient-benefit evaluation that underpins the marketing authorisation of a drug;a catch-up scheme for medicines authorised for use prior to 2006 that lack comprehensive environmental assessments;increased transparency of environmental data;increased consideration of environmental properties in drug development (i.e. greener drug design). However, without validated tools to predict environmental risk earlier in drug development these stakeholder expectations could impact the...
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Specific Challenge:Pharmaceuticals are present in the environment as a consequence of patient use, manufacture, and improper disposal. They predominantly enter the aquatic environment via patient use. In the European Union (EU) an environmental risk assessment (ERA) is required as part of the marketing application and approval for new drugs. Currently the ERA is conducted late in drug development and often parallel to Phase III clinical trials and after significant investment.
The growing regulatory and scientific concerns regarding pharmaceuticals in the environment have reached the point where some stakeholders are advocating:
the inclusion of environmental hazard and risk within the patient-benefit evaluation that underpins the marketing authorisation of a drug;a catch-up scheme for medicines authorised for use prior to 2006 that lack comprehensive environmental assessments;increased transparency of environmental data;increased consideration of environmental properties in drug development (i.e. greener drug design). However, without validated tools to predict environmental risk earlier in drug development these stakeholder expectations could impact the availability of life-changing medicines to patients within Europe and impact the competitiveness of the industry.
For complete information, please see the IMI2 Call 17 topic text.
Scope:The overall aim of this project is to apply innovative approaches to ensure the environmental safety of human medicinal products such that both (i) environmental concerns do not become a barrier to patient access to medicines, and (ii) the intended use of medicines does not pose an unacceptable risk to the environment.
This project aims to refine, extend, validate and implement approaches to the prioritisation and testing of new APIs to ensure the environmental safety of established medicinal products.
For complete information, please see the IMI2 Call 17 topic text.
Expected Impact:This project aims to develop an EU-wide pharmaceutical ecotoxicology database which will:
help all stakeholders better understand the risks posed to the environment by human medicinal products;allow environmental chemists to present their monitoring work in the context of risk;reduce duplication of environmental testing across the industry. The database will also enable the environmental risks of a human medicinal product to be actively managed across its product life cycle and help facilitate the industry extended environmental risk assessment (eERA) model. The availability of tools and models has the potential to deliver significant animal welfare benefits and cost savings without compromising environmental protection, for example, the pharmaceutical industry could save more than EUR 500 million.
Applicants should also indicate how their proposal will impact the competitiveness and industrial leadership of the European Union by, for example, engaging suitable small and medium-sized enterprises (SMEs).
For complete information, please see the IMI2 Call 17 topic text.
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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
The IMI2 JU 17th Call for proposals topics text as well as the Call Conditions are available here
The budget breakdown for this Call is given at the end of the Call topics text, in the Call conditions section, as well as the following information :
1. Eligible countries: described in article 10(2) of the Rules for participation in Horizon 2020 and in article 1 of the Commission Delegated Regulation related to IMI JU.
2. Eligibility and admissibility conditions: described in the IMI2 Manual for evaluation, submission and grant award. See also the Commission Delegated Regulation related to IMI JU.
Proposal page limits and layout: Please refer to Part B of the proposal template in the submission tool below.
3. Evaluation:
Submission and evaluation process, including evaluation criteria and procedure, scoring and threshold are described in the IMI2 Manual for submission, evaluation and grant award. See also the proposal templates for your specific action in section 5, below.
4. Indicative time for evaluation and grant agreement:
Notification of outcomes of stage 1 evaluations: maximum 5 months from deadline for submitting proposals.
The IMI2 JU 17th Call for proposals topics text as well as the Call Conditions are available here
The budget breakdown for this Call is given at the end of the Call topics text, in the Call conditions section, as well as the following information :
1. Eligible countries: described in article 10(2) of the Rules for participation in Horizon 2020 and in article 1 of the Commission Delegated Regulation related to IMI JU.
2. Eligibility and admissibility conditions: described in the IMI2 Manual for evaluation, submission and grant award. See also the Commission Delegated Regulation related to IMI JU.
Proposal page limits and layout: Please refer to Part B of the proposal template in the submission tool below.
3. Evaluation:
Submission and evaluation process, including evaluation criteria and procedure, scoring and threshold are described in the IMI2 Manual for submission, evaluation and grant award. See also the proposal templates for your specific action in section 5, below.
4. Indicative time for evaluation and grant agreement:
Notification of outcomes of stage 1 evaluations: maximum 5 months from deadline for submitting proposals.
Notification of outcomes of stage 2 evaluations: maximum 5 months from deadline for submitting full proposals.
Signature of grant agreements: maximum 3 months from the date of informing successful applicants.
5. Proposal templates, evaluation forms and model grant agreements (MGA):
IMI2 Research and Innovation Action (IMI2-RIA) and Innovation Action (IMI2-IA):
Proposal templates are available after entering the submission tool
Standard evaluation form
IMI2 Model Grant Agreement
Clinical trial template – the Clinical Trial template is compulsory at stage 2 only !
6. Open access must be granted to all scientific publications resulting from Horizon 2020 actions.
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.
Open access to research data
The Open Research Data Pilot has been extended to cover all Horizon 2020 topics for which the submission is opened on 26 July 2016 or later. Projects funded under this topic will therefore by default provide open access to the research data they generate, except if they decide to opt-out under the conditions described in Annex L of the H2020 main Work Programme. Projects can opt-out at any stage, that is both before and after the grant signature.
Note that the evaluation phase proposals will not be evaluated more favourably because they plan to open or share their data, and will not be penalised for opting out.
Open research data sharing applies to the data needed to validate the results presented in scientific publications. Additionally, projects can choose to make other data available open access and need to describe their approach in a Data Management Plan.
Projects need to create a Data Management Plan (DMP), except if they opt-out of making their research data open access. A first version of the DMP must be provided as an early deliverable within six months of the project and should be updated during the project as appropriate. The Commission already provides guidance documents, including a template for DMPs. See the Online Manual.
Eligibility of costs: costs related to data management and data sharing are eligible for reimbursement during the project duration.
The legal requirements for projects participating in this pilot are in the article 29.3 of the Model Grant Agreement.
Members of consortium are required to conclude a consortium agreement prior to the signature of the grant agreement.
7. Additional documents:
Summary of the most relevant provisions for participating in IMI2 actions
2019 Annual Work Plan and Budget
IMI2 Regulators Guidance tool for researchers
IMI JU derogation to H2020 Rules for Participation
Horizon 2020 Rules for Participation
Horizon 2020 Regulation of Establishment
Horizon 2020 Specific Programme
Información adicional de la convocatoria
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