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A training program on novel quantitative methods in regulatory decision making

Objective

REGolution aims to train doctoral candidates in advancing cutting-edge quantitative methodologies that align robust regulatory decision-making with the rapid scientific and technological developments transforming modern drug development. The project will generate innovative frameworks that strengthen the scientific basis of benefit–risk assessment, integrate real-world data (RWD) and advanced analytics, and accelerate the responsible adoption of novel approaches in regulatory science to the benefit of patients.

Fourteen doctoral candidates will form a multidisciplinary network to advance methodological innovations for clinical trials, improve the use and analysis of RWD for underrepresented populations, develop and evaluate methods to improve regulatory and Health Technology Assessment decision-making, and create AI-driven, transparent research methodologies across the medicine lifecycle. Together, they will produce open-access, novel methodological frameworks and software, case studies, and guidance-oriented insights to support more reliable, interpretable, and efficient evidence for regulatory use. Results will be disseminated broadly to regulators, the scientific community, and patient stakeholders to maximise impact, whereas the doctoral candidates will acquire technical and transferable skills that provide a firm base for diverse careers.

The project aligns closely with the MSCA Work Programme by educating young researchers through training, interdisciplinary and intersectoral mobility, strong academic–regulatory collaboration, and high societal relevance. The doctoral candidates will obtain advanced methodological, regulatory and transferable expertise, enhancing employability within and beyond academia and enabling conversion of innovative ideas into tools, frameworks and services relevant to regulatory and pharmacoepidemiological practice. The structure of the REGolution project will ensure strong communication, collaboration, and dissemination skills.

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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.

HORIZON-TMA-MSCA-DN - HORIZON TMA MSCA Doctoral Networks

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Call for proposal

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(opens in new window) HORIZON-MSCA-2025-DN-01

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Coordinator

UNIVERSITEIT UTRECHT
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.

€ 610 571,52
Address
HEIDELBERGLAAN 8
3584 CS Utrecht
Netherlands

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Activity type
Higher or Secondary Education Establishments
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.

No data

Participants (8)

Partners (7)