• The strategic objective of WP2 is to co-ordinate all regulatory information relating to the project in preparation for carrying out all clinical trials and submission of the Paediatric Use Medicines Authorisation (PUMA).

  • Work Package 2

    WP2 is led by Diurnal Limited. The development of the Paediatric Investigation Plan (PIP) and PUMA in relation to the work being undertaken by the TAIN project will be controlled and coordinated by activities from WP2.

  • Work Package 2

    • 2.1 Creation of regulatory working group to collate all regulatory information
    • 2.2 Consultation with the European Medicines Agency
    • 2.3 Prepare and Submit PIP
    • 2.4 Prepare and Submit PUMA
  • Work Package 2

    Deliverables
    Status
    PIP Submission
     
    PUMA Submission
     
    Consultation with the European Medicines Agency