Project description DEENESFRITPL AI-based real-world data tools for medicinal product assessment Real-world data (RWD) is essential in supporting regulatory processes such as safety monitoring. However, evidentiary value for ulterior use cases, as in the pre-authorisation and evaluation phase of medicinal products, is limited by data variability and challenges in analysing data from different settings and sources. As such, it is essential to develop new and optimised methods for RWD analyses. The EU-funded Real4Reg project will develop AI-based data-driven methods and tools for medicinal product assessment. The project relies on highly relevant use cases from regulatory practice and across the product life cycle. Real4Reg will implement the results in existing and emerging guidelines for health regulatory authorities and health technology assessment bodies across Europe. Show the project objective Hide the project objective Objective Real-world evidence derived from real-world data (RWD) has a promising role to inform regulatory decision-making. Based on highly relevant use cases from regulatory practice and across the product lifecycle Real4Reg develops AI-based data-driven methods and tools for the assessment of medicinal products. Findings will inform training activities on good practice examples and will be implemented in existing and emerging guidelines for both health regulatory authorities and health technology assessment (HTA) bodies across Europe. There is urgent need to enable the use and establish the value of the application of RWD across the spectrum of regulatory use cases. The use of RWD is established in regulatory processes such as safety monitoring, but evidentiary value for further use cases, especially in the pre-authorisation and evaluation phase of medicinal products, is rudimentary. The use of RWD in post-authorisation steps is constrained by data variability and by challenges in analysing data from different settings and sources. Thus, the development of new and optimised methods for RWD analyses is essential. Real4Reg addresses the challenges and opportunities of RWD analyses across different health care systems by involving multiple stakeholders to work together in a collaborative approach, also outreaching to already established European initiatives. Our consortium assembles partners with outstanding excellence in the field of RWD analyses, including experts from regulatory agencies/ HTA (BfArM, DKMA, Infarmed), academia (Fraunhofer, UEF, CSC, AU, DZNE) and patient organisations (EUpALS, EIWH). In an advisory board stakeholders provide input and guidance to the project, including patients, industry, payers, HTA bodies and healthcare professionals. The structure and approach of our project facilitates the successful implementation of the effective use of RWD in regulatory decision-making and HTA, and ultimately supports the application of better medicines for patients. Fields of science natural sciencescomputer and information sciencesartificial intelligencenatural sciencescomputer and information sciencesdata sciencemedical and health sciencesbasic medicinepharmacology and pharmacypharmaceutical drugs Keywords AI digital twins RWE implementation in regulatory-decision making HTA Pharmacoepidemiology Programme(s) HORIZON.2.1 - Health Main Programme HORIZON.2.1.5 - Tools, Technologies and Digital Solutions for Health and Care, including personalised medicine Topic(s) HORIZON-HLTH-2022-TOOL-11-02 - New methods for the effective use of real-world data and/or synthetic data in regulatory decision-making and/or in health technology assessment Call for proposal HORIZON-HLTH-2022-TOOL-11 See other projects for this call Funding Scheme HORIZON-RIA - HORIZON Research and Innovation Actions Coordinator BUNDESINSTITUT FUR ARZNEIMITTEL UND MEDIZINPRODUKTE Net EU contribution € 1 495 828,75 Address KURT GEORG KIESINGER ALLEE 3 53175 Bonn Germany See on map Region Nordrhein-Westfalen Köln Bonn, Kreisfreie Stadt Activity type Research Organisations Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Total cost € 1 495 828,75 Participants (9) Sort alphabetically Sort by Net EU contribution Expand all Collapse all ITA-SUOMEN YLIOPISTO Finland Net EU contribution € 1 255 375,00 Address YLIOPISTONRANTA 8 70211 KUOPIO See on map Region Manner-Suomi Pohjois- ja Itä-Suomi Pohjois-Savo Activity type Higher or Secondary Education Establishments Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Total cost € 1 255 375,00 INFARMED - AUTORIDADE NACIONAL DO MEDICAMENTO E PRODUTOS DA SAUDE IP Portugal Net EU contribution € 1 061 812,50 Address AVENIDA DO BRASIL 53 1749 004 Lisboa See on map Region Continente Área Metropolitana de Lisboa Área Metropolitana de Lisboa Activity type Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments) Links Contact the organisation Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Total cost € 1 061 812,50 FRAUNHOFER GESELLSCHAFT ZUR FORDERUNG DER ANGEWANDTEN FORSCHUNG EV Germany Net EU contribution € 1 349 982,50 Address HANSASTRASSE 27C 80686 Munchen See on map Region Bayern Oberbayern München, Kreisfreie Stadt Activity type Research Organisations Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Total cost € 1 349 982,50 LAEGEMIDDELSTYRELSEN Denmark Net EU contribution € 683 750,00 Address AXEL HEIDES GADE 1 2300 Kobenhavn S See on map Region Danmark Hovedstaden Byen København Activity type Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments) Links Contact the organisation Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Total cost € 683 750,00 AARHUS UNIVERSITET Denmark Net EU contribution € 456 610,00 Address NORDRE RINGGADE 1 8000 Aarhus C See on map Region Danmark Midtjylland Østjylland Activity type Higher or Secondary Education Establishments Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Total cost € 456 610,00 CSC-TIETEEN TIETOTEKNIIKAN KESKUS OY Finland Net EU contribution € 492 160,00 Address KEILARANTA 14 02101 Espoo See on map Region Manner-Suomi Helsinki-Uusimaa Helsinki-Uusimaa Activity type Other Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Total cost € 492 160,00 DEUTSCHES ZENTRUM FUR NEURODEGENERATIVE ERKRANKUNGEN EV Germany Net EU contribution € 78 906,25 Address VENUSBERG-CAMPUS 1/99 53127 Bonn See on map Region Nordrhein-Westfalen Köln Bonn, Kreisfreie Stadt Activity type Research Organisations Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Total cost € 78 906,25 EUROPESE VERENIGING VOOR PROFESSIONALS EN PATIENTEN MET ALS Belgium Net EU contribution € 62 500,00 Address VAARTKOM 17 3000 Leuven See on map Region Vlaams Gewest Prov. Vlaams-Brabant Arr. Leuven Activity type Other Links Contact the organisation Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Total cost € 62 500,00 EUROPEAN INSTITUTE OF WOMEN'S HEALTH COMPANY LIMITED BY GUARANTEE Ireland Net EU contribution € 62 500,00 Address ASHGROVE HOUSE ASHGROVE INDUSTRIAL ESTATE KILL AVENUE DUN LAOGHAIRE A96 N9K0 DUBLIN See on map SME The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed. Yes Region Ireland Eastern and Midland Dublin Activity type Research Organisations Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Total cost € 62 500,00