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Prioritisation and Risk Evaluation of Medicines in the EnviRonment

Project description

Environmental risk assessment of medicines

There are nearly 2 000 active pharmaceutical ingredients (APIs) in use, but little is known about the risks they pose to the environment. As a result, there is an urgent need for science-based methods that identify environmental threats earlier in the drug development process. The EU-funded PREMIER project proposes an information and assessment system based on minimum testing that describes the environmental risk of APIs, including relevant human metabolites and environmental transformation products. The system will deliver tailored assessment, identify potential environmental damage and make existing environmental data more accessible for all stakeholders. The project will combine world-leading research on the environmental threats represented by APIs with the principles of co-design and smart knowledge-based IT.

Objective

There are around 1900 active pharmaceutical ingredients (APIs) in use, yet the environmental risks of only a small proportion of these has been assessed. This calls for pragmatic science-based approaches for prioritising existing APIs in terms of their environmental risk. Such approaches could also be used pro-actively, i.e. to identify environmental concerns earlier in the drug development process, thereby contributing to a more sustainable future. The overall aim of PREMIER is to deliver an API information and assessment system for characterising the potential environmental risks of APIs, including relevant human metabolites and environmental transformation products, based on minimal testing. This system will be designed to screen and prioritise legacy APIs for tailored environmental assessment; identify potential environmental hazards associated with APIs in development; and to make the available environmental data more accessible for all stakeholders. The system will be optimized and validated using case studies on approximately 25 APIs. PREMIER will realize its aim by combining world-leading research on the environmental risks of APIs with
the principles of co-design and smart knowledge-based IT. Through this combination, we want to be more than a conventional research project. We want to ensure that the results of our ground-breaking research “work” address all the societal concerns about the potential risks posed by the presence of pharmaceuticals in the environment.

Fields of science (EuroSciVoc)

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Keywords

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Programme(s)

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Topic(s)

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Funding Scheme

Funding scheme (or “Type of Action”) inside a programme with common features. It specifies: the scope of what is funded; the reimbursement rate; specific evaluation criteria to qualify for funding; and the use of simplified forms of costs like lump sums.

RIA - Research and Innovation action

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Call for proposal

Procedure for inviting applicants to submit project proposals, with the aim of receiving EU funding.

(opens in new window) H2020-JTI-IMI2-2019-17-two-stage

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Coordinator

STICHTING RADBOUD UNIVERSITEIT
Net EU contribution

Net EU financial contribution. The sum of money that the participant receives, deducted by the EU contribution to its linked third party. It considers the distribution of the EU financial contribution between direct beneficiaries of the project and other types of participants, like third-party participants.

€ 725 308,96
Address
HOUTLAAN 4
6525 XZ Nijmegen
Netherlands

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Region
Oost-Nederland Gelderland Arnhem/Nijmegen
Activity type
Higher or Secondary Education Establishments
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Total cost

The total costs incurred by this organisation to participate in the project, including direct and indirect costs. This amount is a subset of the overall project budget.

€ 860 837,20

Participants (26)

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