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Breakthrough Regulatory Innovation and Development throuGh sandbox Environments

Objective

BRIDGE aims to enhance healthcare innovation in Europe by developing a comprehensive framework for designing and operationalizing regulatory sandboxes. By addressing current regulatory limitations and engaging all stakeholders while ensuring compliance, the project seeks to create adaptable, fit-for-purpose methodologies that strengthen the regulatory ecosystem's capacity to promote healthcare innovation.
The project’s objectives include identifying and analysing existing regulatory sandboxes across various domains and maturity levels, to determine how their modules can complement current healthcare regulations. BRIDGE will develop a horizon scanning methodology to continuously identify emerging technologies that challenge existing regulatory systems, analyzing their requirements for potential inclusion in regulatory sandboxes to ensure adaptability within an evolving innovation ecosystem.
Through multi-stakeholder consultations, BRIDGE will elaborate and assess case studies, as well as develop operational checklists for module design and evidence packages to guide tailored sandbox launches. The project will also develop the Modular Operational Sandbox for Healthcare Innovation and Compliance (MOSAIC), an architectural model with interconnected modules featuring detailed functional specifications and mapped information flows aligned with specific case studies.
Additionally, BRIDGE will engage key stakeholders—including regulatory bodies, industry consortia, HTA bodies, payers, healthcare providers, and patients—in an in-depth analysis, consultation, and consensus-building process to ensure the sandbox approach is comprehensive, functional, and adaptable to future advancements. Finally, the project will deliver comprehensive recommendations for the sandbox methodology’s end-to-end operations, encompassing legal, compliance, policy, and regulatory outputs to provide a robust implementation framework.

Fields of science (EuroSciVoc)

CORDIS classifies projects with EuroSciVoc, a multilingual taxonomy of fields of science, through a semi-automatic process based on NLP techniques. See: The European Science Vocabulary.

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Keywords

Project’s keywords as indicated by the project coordinator. Not to be confused with the EuroSciVoc taxonomy (Fields of science)

Programme(s)

Multi-annual funding programmes that define the EU’s priorities for research and innovation.

Topic(s)

Calls for proposals are divided into topics. A topic defines a specific subject or area for which applicants can submit proposals. The description of a topic comprises its specific scope and the expected impact of the funded project.

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.

HORIZON-JU-RIA - HORIZON JU Research and Innovation Actions

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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) HORIZON-JU-IHI-2024-08-two-stage

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Coordinator

VLAAMSE INSTELLING VOOR TECHNOLOGISCH ONDERZOEK N.V.
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.

€ 1 097 772,50
Address
BOERETANG 200
2400 Mol
Belgium

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Region
Vlaams Gewest Prov. Antwerpen Arr. Turnhout
Activity type
Research Organisations
Links
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.

€ 1 197 772,50

Participants (27)

Partners (13)

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