The guidance outlines the main steps to take in preparation for submission and a list of documents required for the main1 types of paediatric submissions
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European Paediatric Translational Research Infrastructure (EPTRI)
Published by EPTRI
Drug DevelopmentpaediatricRegulatory Affairsresearch infrastructureTranslational ResearchThe EPTRI Centralised Services are provided by the EPTRI CMO and dedicated experts. These services include:
*Providing access to paediatric patients’ cohorts
*Providing access to paediatric samples and related data
*Advice on in-vivo / in-silico non-clinical study design
*Advice on in-vivo / in-silico clinical study design
*Advice and document preparation for regulatory and ethics procedures
*Advice on preparing HTA reports for paediatric medicines, diagnostics, and medical devices
*Advice on data and sample sharing preparation
*Support with applications to public and private funding opportunities
