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organization

AEMPS

Agencia Española de Medicamentos y Productos Sanitarios
Country: Spain
11 Projects, page 1 of 3
  • Project . 2015 - 2016
    Open Access mandate for Publications
    Funder: EC Project Code: 643796
    Overall Budget: 997,938 EURFunder Contribution: 997,938 EUR
    Partners: HL7 INTERNATIONAL, REGIONE LOMBARDIA, ILiM, EMPIRICA, NEN, HPRA, CUSTODIX, AEMPS

    The CSA will enhance the safety of cross-border healthcare through interoperable ePrescriptions. epSOS solved the message transfer problem, but encountered 2 serious “delivery” problems: the univocal identification of medicinal products (MPs) dispensed abroad, and substitution challenges. Global SDOs (WHO, HL7, IHTSDO, ISO/CEN, GS1), EU regulatory agencies (EMA), MS Competent Authorities, major stakeholders (industry, health professionals, patients) harmonise their related efforts to deliver • common data models - expanding upon epSOS and existing standards (ISO/IDMP) - for prescribed MPs • a common meta-vocabulary for unambiguous definition, description, and identification of MPs • rules to harmonise practices of therapeutic and economic substitution • a roadmap for post-project actions and implementations • policy recommendations for the EU-USA road mapping process (MoU) Work will link to related research & innovation activities of SDOs, epSOS, policy and regulatory processes (eHealth Network), the three other PHC34 projects. WP1 develops a concise conceptual framework, including use case scenarios where the identification of a MP is an issue, including pharmacological and pharmacokinetic attributes, clinical indications and risks. WPs 2 address the identification and description of the pharmaceutical products, considering implementability as essential. WP3 investigates the situation in MSs with respect to substitution, and explores options for substitution. Each track develops a set of concrete solutions and road map recommendations, validated by experts in F2F meetings and workshops in WP4. Fostering exploitation by MS regulatory agencies and communication of results is the duty of WP5. The project involves national competent authorities, SDOs and stakeholders not part of the core team at an early stage to assure the practicability, acceptance and trust in the solutions developed. The CSA lasts 2 years involving 8 beneficiaries and about 25 expert organisations.

  • 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
    Funder: EC Project Code: 282521
    Partners: ERASMUS MC, BWFH, VUA, FONDAZIONE MARIO NEGRI SUD-CENTRO DI RICERCHE FARMACOLOGICHE EB IOMEDICHE, University of Bath, FONDAZIONE-SIMG, PHARMO, UniMiB, University of Bremen, VUA...
  • 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.

  • Funder: EC Project Code: 211738
    Partners: UB, ISCIII, EORTC, HHU, REGIONH, CONSORZIO ITALIANO PER LA RICERCA MEDICA, Medical University of Warsaw, IRFMN, University of Leeds, HRB...