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MHRA

MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY
6 Projects, page 1 of 2
  • Project . 2018 - 2020
    Open Access mandate for Publications and Research data
    Funder: EC Project Code: 807010
    Overall Budget: 2,140,980 EURFunder Contribution: 1,168,750 EUR
    Partners: International Health, NOVARTIS, AbbVie, MHRA, CSL BEHRING GMBH, UMC, THE INTERNATIONAL COUNCIL FOR HARMONISATION OF TECHNICAL REQUIREMENTS FOR PHARMACEUTICALS FOR HUMAN USE, Lareb, PFIZER, DANISH MEDICINES AGENCY...

    This proposal seeks to build on the mobile application (app) functionality delivered through the original WEB-RADR project to expand access to the platform and the reach of the information contained within it. It will achieve this by making the functionality available through application programming interfaces (APIs), meaning that third party organisations will be able to embed WEB-RADR platform functionality into their own systems, applications and websites. An important component to this will be a terminology/classification mapping activity involving the three core healthcare terminology owners; MedDRA MSSO, SNOMED International and WHO. The mapping will facilitate communication between regulatory and healthcare databases by establishing mapping protocols and delivering an initial mapping between a subset of key pharmacovigilance terms. The project has established use cases and adopters for the proposed functionality through the networks established through the original WEB-RADR delivery, and has a diverse range of partners keen to utilise different aspects of the proposed solutions including regulatory authorities, health charities and system providers.

  • Open Access mandate for Publications and Research data
    Funder: EC Project Code: 825881
    Overall Budget: 1,986,000 EURFunder Contribution: 1,986,000 EUR
    Partners: ANSM, STATE AGENCY OF MEDICINES, FAMHP, THE MEDICINES AUTHORITY, AIFA, STATE MEDICINES CONTROL AGENCY, AGENTSCHAP COLLEGE TER BEOORDELING VAN GENEESMIDDELEN, MHRA, AGES, HPRA...

    Lack of specific relevant know-how in regulatory science delays the development of new treatment strategies or limits the chances that promising innovations will reach patients. STARS aims to improve the direct regulatory impact of results obtained in medical research. Seventeen European countries are represented in the consortium through their national competent authorities, alongside academic and industry representatives, and associations with relevant experience. The work plan includes the development of a Comprehensive Inventory of existing support activities based on a detailed analysis of the currently established programmes. This analysis is also the basis for development of a Common Strategy to strengthen regulatory sciences and two curricula, the Core Curriculum specifying essential knowledge for the professional training of clinical scientists and the Comprehensive Curriculum defining relevant knowledge for specific post-graduate programmes. Three pilot projects aim (i) to transfer an identified best practice example for training programmes to other EEA countries, (ii) to implement a new support activity addressing a gap in regulatory knowledge of significant relevance and (iii) to implement the Comprehensive Curriculum. STARS will deliver consensual recommendations ensuring sustainable support of academic research and will propose additional support mechanisms based on a comprehensive analysis of needs. STARS has the objective and the potential to complement, coordinate and harmonise regulatory efforts among Member States and at European level to support academic health research for the benefit of patients. The aim is to reach academic researchers very early in the planning of relevant grant applications. A further aim is to strengthen regulatory knowledge in general by reaching clinical scientists during professional training and qualification.

  • Open Access mandate for Publications and Research data
    Funder: EC Project Code: 951668
    Overall Budget: 1,879,220 EURFunder Contribution: 1,879,220 EUR
    Partners: VWS, CISPA, CEA, INTRAVACC, INSTITUTE FOR FOOD AND AGRICULTURE RESEARCH AND TE, INRAE, LSHTM, Leiden University Medical Center, ISCIII, INSTRUCT-ERIC...

    The TRANSVAC-DS project further builds on the outstanding success of EC-funded projects:TRANSVAC1 and TRANSVAC2 and proposes the establishment of a truly sustainable European vaccine infrastructure, which will build upon the lessons learned, activities and achievements of the TRANSVAC1/2 projects. Two infrastructure projects -TRANSVAC1 and TRANSVAC2- have been funded by the European Commission which -through the provision of state-of-the-art scientific-technical vaccine development services, technical training, and innovative vaccine research and development- have provided very significant support to European vaccine researchers and developers. Support has been, and is being provided to the development of human and veterinary prophylactic and therapeutic vaccines. The twenty-five partners in the TRANSVAC-DS consortium that will contribute to the outcome of the project represent ten EU Member States and Associated Countries and include leading organisations from the European vaccine R&D field. The main output of TRANSVAC-DS will be a conceptual design report that will describe in detail the maturity of the concept and be the basis for the establishment of a permanent and sustainable vaccine infrastructure of direct relevance to and benefit for Europe and further afield. As part of the design report, a five-year business plan will be delivered together with an implementation plan that will guide the further establishment of a sustainable European vaccine infrastructure.

  • Open Access mandate for Publications
    Funder: EC Project Code: 101007799
    Overall Budget: 38,542,600 EURFunder Contribution: 18,600,000 EUR
    Partners: UOXF, DTU, INESC TEC, University of Gothenburg, CISPA, MCT BIOSEPARATION APS, Imperial, CHDR, TiHo, VCB...

    Inno4Vac proposes an ambitious programme that will harness the latest advances in immunology, disease modelling, and modelling for tackling persistent scientific bottlenecks in vaccine development and for de-risking and accelerating this process. To reach this aim the project is divided into four interlinked subtopics. In Subtopic 1, artificial intelligence in combination with big data analysis and computational modelling will be used to build an open-access and cloud-based platform for in silico vaccine efficacy assessment and development. Subtopic 2 will develop new and improved controlled human infection models (CHIM) against influenza, RSV and C. difficile that will enable early vaccine efficacy evaluation. Subtopic 3 will contribute to the development of cell-based human in vitro 3D models that resemble the in vivo situation of an infection at the mucosa and more reliably predict immune protection. These models will be combined with the development of related functional immune assays for clinically relevant (surrogate) endpoints. Finally, Subtopic 4 will develop a modular one-stop computational platform for in silico modelling of vaccine bio-manufacturing and stability testing. In parallel to the scientific-technical work, the partners will develop strategies and roadmaps for positioning the newly developed models in the regulatory framework and integrating them into pharmaceutical vaccine development. The overall workplan is underpinned by horizontal activities on coordination/management and dissemination/communication, including data management and future sustainability. To achieve these ambitious objectives, Inno4Vacc has assembled a multidisciplinary consortium from academic and research institutions, industries, regulatory bodies, and vaccine R&D alliances. This unique partnership brings together clinical, immunological, microbiological, systems biology, mathematical models, and regulatory expertise and includes world-leaders in each respective field.

  • Open Access mandate for Publications
    Funder: EC Project Code: 875299
    Overall Budget: 20,731,000 EURFunder Contribution: 18,994,900 EUR
    Partners: STATE AGENCY OF MEDICINES, MINSAIT, FINNISH MEDICINES AGENCY FIMEA, BIDMC, Federico II University Hospital, ARIA, MEDICAL PRODUCTS AGENCY MPA, DW, HEALTH AND WELFARE INFORMATION SYSTEMS CENTRE, SIEC BADAWCZA LUKASIEWICZ - POZNANSKI INSTYTUT TECHNOLOGICZNY...

    This innovation action will give a powerful impulse to implementation of ISO IDMP (ID of Medicinal Products) standards in EU Member States drug databases, supporting safe cross-border ePrescription/eDispensation and effective pharmacovigilance. Once EU-interoperable data on medicines taken by patients become available, further benefits will accrue through better health data for improved clinical decision support, patient empowerment, public health and clinical research. New opportunities will arise for pharma industry, software developers, SMEs providing smart apps and others, thereby fostering their innovation capacity and competitiveness. The many challenges still to be faced on this road will be tackled by a powerful consortium assembling all relevant actors, with critical mass for impact throughout the EU. After 10 years of development, the IDMP suite of standards is ready for implementation. Though some isolated implementation work has started, the time is now ripe for a more concerted effort towards large-scale implementation, contributing to this global interoperability endeavour and delivering benefits to EU citizens. Project ambition centres on conversion of key regulatory and clinical processes to use IDMP. These information value chains must be converted over their full length from data input to data repositories to data usage. Project work spans all three areas, focussing on the most challenging, the implementation of EU and national SPOR (substances, products, organisations, referentials) data bases, including establishing an EU Substance Reference System (EU-SRS). Such information is fundamental to cross-border ePrescription where safe dispensation may require reliable identification of substances in available products. 19 countries are represented, including 26 national Drug and eHealth Agencies. Stakeholders are involved through their associations. Duration is 4 years, budget € 21 m, with requested funding € 19 m.