The DEEP project has received research funding from the European Union under the 7th Framework Programme

WP6 - Management of regulatory and pharmacoeconomic issues

This WP deals with the provision of information needed to fulfil and comply with the regulatory requirements for the registration of the first-line use of the new formulation ofdeferiprone in paediatrics. In detail, WP6 entails:

•    to coordinate, prepare and submit the Paediatric Investigation Plan (PIP) for deferiprone to the EMA/PDCO in order to apply for a PUMA application or a Type II variation. The PIP will include the planned clinical trials in the paediatric age groups covered by this Project
•    to provide a pharmacoeconomic evaluation and HTA evaluation on the use of the new deferiprone formulation in paediatrics
•    to organize the results of the studies in compliance with the requirement for a PUMA application or a Type II variation

WP Leader: Ian Wong (FGB)
Involved Partners: CVBF, AOC, NKUA, UHCT, MPHS, CU, ApoPharma, GIAMBRONE, AORC, AODP, PB, FGB, CNGMO
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