Paediatric Investigation Plan

This service aims to support companies with the intention to submit a Paediatric Investigation Plan at the European Medicines Agency. The Paediatric Investigation Plan, PIP, established by the EU Paediatric Regulation (Regulation (EU) no 1901/2006) is a development plan including a description and timing of the measures (quality, nonclinical and clinical) to obtain all the needed data to conduct studies in children to support the authorisation of the medicinal product in this patient population. The PIP is mandatory for all new medicinal products in the European Union and should be submitted prior the initiation of Phase 3 clinical trials. PIPs are evaluated by the Paediatric Committee, the PDCO. This service is offered to startups, pharma, biotech, med-tech companies developing medicinal product in Europe. EIC beneficiaries will have the opportunity to get support from regulatory experts on writing the PIP Scientific Document according to the European Medicines Agency template, receive strategic support on the paediatric measures (quality, nonclinical and clinical) to be included in the PIP and regulatory advice during the submission, validation and evaluation of the PIP at European Medicines Agency. Additionally, during the whole procedure, meetings will be conducted with EIC beneficiaries to discuss the progress of the project and evaluation by the PDCO.