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Regulatory Science Framework for Nano(bio)material-based Medical Products and Devices

Objective

REFINE proposes a Regulatory Science Framework for the risk-benefit assessment of medical products and medical devices that are based on nanomedicines and biomaterials. The heart of our framework is the development of a product-specific Decision Support System that identifies the most efficient way to deliver the data required by regulation by the best-fitting methods. The decision tree will explicate the product’s specific regulatory challenges and the priorities of both missing data and missing methods to match these challenges. It will thus allow planning a cost-and time efficient strategy both for necessary measurements and for the advancement of methods. Our approach is aligned with the industrial R&D practice of stage gating.
We will demonstrate the relevance of the framework for the most pressing regulatory challenges, which are: borderline products, nanosimilars, and products combining several functionalities. In order to do so, we will identify the regulatory challenges with Regulation Authorities from Europe and abroad, and design methods for tiered decision tree, guided by the latest scientific knowledge. We will study/predict physiological distribution of nanomedicines and biomaterials, as well as develop and validate new analytical or experimental methods and assays requested by the regulators. These latter development will be performed in a quality management system, ensuring the possible standardisation of our assays.
REFINE will gather a wide community of stakeholders in regulation, industry, science, technology development, patients, and end-users, into a Consortium for the Advancement of Regulatory Science in Biomaterials and Nanomedicine.

Coordinator

COMMISSARIAT A L ENERGIE ATOMIQUE ET AUX ENERGIES ALTERNATIVES

Address

Rue Leblanc 25
75015 Paris 15

France

Activity type

Research Organisations

EU Contribution

€ 1 090 625

Participants (13)

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STIFTELSEN SINTEF

Norway

EU Contribution

€ 12 730

EIDGENOSSISCHE MATERIALPRUFUNGS- UND FORSCHUNGSANSTALT

Switzerland

EU Contribution

€ 476 096,25

RIJKSINSTITUUT VOOR VOLKSGEZONDHEID EN MILIEU

Netherlands

EU Contribution

€ 966 425

JRC -JOINT RESEARCH CENTRE- EUROPEAN COMMISSION

Belgium

EU Contribution

€ 458 955

GESELLSCHAFT FUR BIOANALYTIK MUNSTER EV

Germany

EU Contribution

€ 685 967,25

THE PROVOST, FELLOWS, FOUNDATION SCHOLARS & THE OTHER MEMBERS OF BOARD OF THE COLLEGE OF THE HOLY & UNDIVIDED TRINITY OF QUEEN ELIZABETH NEAR DUBLIN

Ireland

EU Contribution

€ 633 990

THE UNIVERSITY OF LIVERPOOL

United Kingdom

EU Contribution

€ 848 441,25

UNIVERSITY OF BRIGHTON

United Kingdom

EU Contribution

€ 214 806,25

GREENDECISION SRL

Italy

EU Contribution

€ 450 266,25

BIOKERALTY RESEARCH INSTITUTE AIE

Spain

EU Contribution

€ 102 395

AMATSIGROUP

France

EU Contribution

€ 196 306,25

EUROPEAN RESEARCH SERVICES GMBH

Germany

EU Contribution

€ 186 750

SINTEF AS

Norway

EU Contribution

€ 1 644 187,50

Project information

Grant agreement ID: 761104

Status

Ongoing project

  • Start date

    1 December 2017

  • End date

    30 November 2021

Funded under:

H2020-EU.2.1.2.2.

  • Overall budget:

    € 7 967 941

  • EU contribution

    € 7 967 941

Coordinated by:

COMMISSARIAT A L ENERGIE ATOMIQUE ET AUX ENERGIES ALTERNATIVES

France