REGolution · A training program on novel quantitative methods in regulatory decision making
Horizon Europe — Marie Skłodowska-Curie Actions
- Duration
- 2027-01-01 → 2030-12-31
- EU contribution
- €4,262,596
- Participants
- 16
- Scheme
- HORIZON-TMA-MSCA-DN
Lines connect the coordinator with its partners.
Project 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.
Original text from CORDIS.
Participants
- UNIVERSITEIT UTRECHT · UtrechtCoordinatorNetherlands
- AGENCE NATIONALE DE SECURITE DU MEDICAMENT ET DES PRODUITS DE SANTE · Saint Denis CedexFrance
- AGENTSCHAP COLLEGE TER BEOORDELING VAN GENEESMIDDELEN · UtrechtNetherlands
- BUNDESINSTITUT FUR IMPFSTOFFE UND BIOMEDIZINISCHE ARZNEIMITTEL · LangenGermany
- DIREKTORATET FOR MEDISINSKE PRODUKTER · OSLONorway
- FRIEDRICH-ALEXANDER-UNIVERSITAET ERLANGEN-NUERNBERG · ErlangenGermany
- GOTTFRIED WILHELM LEIBNIZ UNIVERSITAET HANNOVER · HannoverGermany
- KOBENHAVNS UNIVERSITET · KOBENHAVNDenmark
- LAEGEMIDDELSTYRELSEN · KOBENHAVN SDenmark
- PANEPISTIMIO IOANNINON · IOANNINAGreece
- STICHTING RADBOUD UNIVERSITAIR MEDISCH CENTRUM · NijmegenNetherlands
- STICHTING RADBOUD UNIVERSITEIT · NijmegenNetherlands
- UNIVERSITAETSMEDIZIN GOETTINGEN - GEORG-AUGUST-UNIVERSITAET GOETTINGEN - STIFTUNG OEFFENTLICHEN RECHTS · GoettingenGermany
- UNIVERSITAIR MEDISCH CENTRUM UTRECHT · UtrechtNetherlands
- UNIVERSITE PARIS CITE · ParisFrance
- UNIVERSITETET I OSLO · OsloNorway
Links
Data: CORDIS, © European Union