Paediatric Investigation Plan

Fundació Privada Món Clínic Barcelona

Spain

Service ID:

EP304S3
Service description

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.

Sector
Biotechnology
Health and medical care
Pharmaceuticals
Technology Readiness Level
TRL 5 – Technology validated in relevant environment
TRL 6 – Technology demonstrated in relevant environment
TRL 7 – System prototype demonstration in operational environment
TRL 8 – System complete and qualified
TRL 9 – Actual system proven in operational environment
Financial requirements

€200/hour.

Disclaimer related to service

Service timelines will be discussed specifically for each project.

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