• Multi-stakeholder workshop to further improve the implementation of the Paediatric Regulation

    The workshop, organised by the European Medicines Agency (EMA) and the European Commission, follows the publication of the Commission’s ten-year report on implementation of the Paediatric Regulation and the state of paediatric medicines in the European Union.
    The aim is to discuss potential improvements of the implementation of the Regulation. It will explore opportunities regarding paediatric needs, timely completion of paediatric investigation plans (PIP), and processes and expectations for handling PIP applications. This workshop is a crucial step for the development of a concrete action plan to address challenges identified with medicine development for children in Europe. Invited stakeholders include patients, academia, healthcare professionals and industry.

  • EPTRI – European Paediatric Translational Research Infrastructure.

    ID-EPTRI Approval
    A great success for paediatric medicines development.
    The ID-EPTRI (European Paediatric Translational Research Infrastructure) project, coordinated by CVBF and submitted within the INFRADEV-2016-2017 single-stage call for proposals, aimed to create the framework for a new paediatric Research Infrastructure (RI) has been successfully evaluated and granted 3.00 million Euro in funding from the European Commission.
    The project will develop a new RI, EPTRI, that is complementary to the existing Biomed Research Infrastructures acting as a ‘Paediatric Common Service’ in the ESFRI Scenario. The project involves 26 partners from EU and non-EU countries including consolidated RIs, top-level universities, scientific and clinical centres of excellence in Europe and is aimed to create a Conceptual Design Report (CDR) to realize the European paediatric RI.
    INCiPiT will actively participate into the project.