Objective 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. Fields of science medical and health scienceshealth scienceshealth care serviceseHealthmedical and health scienceshealth sciencespublic healthmedical and health sciencesbasic medicinepharmacology and pharmacypharmaceutical drugsnatural sciencescomputer and information sciencessoftwaresoftware applicationssystem softwaremedical and health sciencesbasic medicinepharmacology and pharmacyadverse drug reactions Programme(s) H2020-EU.3.1. - SOCIETAL CHALLENGES - Health, demographic change and well-being Main Programme H2020-EU.3.1.5. - Methods and data Topic(s) PHC-34-2014 - eHealth interoperability Call for proposal H2020-PHC-2014-2015 See other projects for this call Sub call H2020-PHC-2014-single-stage Funding Scheme CSA - Coordination and support action Coordinator EMPIRICA GESELLSCHAFT FUR KOMMUNIKATIONS UND TECHNOLOGIEFORSCHUNG MBH Net EU contribution € 191 875,00 Address Oxfordstrasse 2 53111 Bonn Germany See on map Region Nordrhein-Westfalen Köln Bonn, Kreisfreie Stadt Activity type Private for-profit entities (excluding Higher or Secondary 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 Other funding € 0,00 Participants (8) Sort alphabetically Sort by Net EU contribution Expand all Collapse all CUSTODIX NV Belgium Net EU contribution € 299 625,00 Address Kortrijksesteenweg 214 b3 9830 Sint-martens-latem 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 Vlaams Gewest Prov. Oost-Vlaanderen Arr. Gent Activity type Private for-profit entities (excluding 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 Other funding € 0,00 HEALTH PRODUCTS REGULATORY AUTHORITY Ireland Net EU contribution € 110 625,00 Address Earlsfort centre block a kevin o malley house earlsfort terrace 2 Dublin See on map Region Ireland Northern and Western Border 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 Other funding € 0,00 REGIONE LOMBARDIA Italy Net EU contribution € 30 000,00 Address Piazza citta di lombardia 1 20124 Milano See on map Region Nord-Ovest Lombardia Milano Activity type Public bodies (excluding Research Organisations and Secondary or Higher 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 Other funding € 0,00 Third-party Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure. AZIENDA REGIONALE PER L'INNOVAZIONEE GLI ACQUISTI S.P.A. Italy Net EU contribution € 50 625,00 Address Via torquato taramelli 26 20124 Milano See on map Region Nord-Ovest Lombardia Milano Activity type Private for-profit entities (excluding Higher or Secondary 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 Other funding € 0,00 HL7 INTERNATIONAL FONDATION Belgium Net EU contribution € 90 313,00 Address Square de meeus 38-40 1000 Bruxelles / brussel See on map Region Région de Bruxelles-Capitale/Brussels Hoofdstedelijk Gewest Région de Bruxelles-Capitale/ Brussels Hoofdstedelijk Gewest Arr. de Bruxelles-Capitale/Arr. Brussel-Hoofdstad Activity type Research Organisations 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 Other funding € 0,00 SIEC BADAWCZA LUKASIEWICZ - POZNANSKI INSTYTUT TECHNOLOGICZNY Poland Net EU contribution € 87 625,00 Address Ul ewarysta estkowskiego 6 61-755 Poznan See on map Region Makroregion północno-zachodni Wielkopolskie Miasto Poznań Activity type Research Organisations 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 Other funding € 0,00 STICHTING KONINKLIJK NEDERLANDS NORMALISATIE INSTITUUT Netherlands Net EU contribution € 62 875,00 Address Vlinderweg 6 2623 AX Delft See on map Region West-Nederland Zuid-Holland Delft en Westland 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 Other funding € 0,00 AGENCIA ESPANOLA DE MEDICAMENTOS Y PRODUCTOS SANITARIOS Spain Net EU contribution € 74 375,00 Address C/ campezo edificio 8 1 28022 Madrid See on map Region Comunidad de Madrid Comunidad de Madrid Madrid Activity type Public bodies (excluding Research Organisations and Secondary or Higher 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 Other funding € 0,00
