ITCC-P4 approved as stakeholder of European Medicines Agency

As part of ITCC-P4's outreach to the greater paediatric community, the consortium's members had presentations at various international meetings, leading to significant awareness of the platform and participants. To enable regulatory filings in the EU through the development of comprehensive preclinical data packages necessary to move drugs into clinical trials for children with solid tumours a manuscript entitled “International consensus on minimum preclinical testing requirements for the development of innovative therapies for children and adolescents with cancer” was published in Molecular Cancer Therapeutics. Based on this white paper, the first of its kind for global paediatric research, ITCC-P4 submitted its offer for review and discussion to the European Medicines Agency. ITCC-P4 has been elected to present its offer to EMA and FDA representatives during an Innovation Task Force (ITF) briefing meeting.  As a result, ITCC-P4 qualified as an EMA stakeholder allowing ITCC-P4 to sustain and continuously evolve the generation of relevant high quality preclinical data for regulatory decisions.