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
FDA Pediatrics Advisory Committee
Published by IRDiRC
Biomedical EthicsEarly Access SupportPaediatric MedicinePaediatric RegulationPaediatric ResearchPaedriatic Advisory CommitteeRegulatory AdviceRegulatory AffairsThe Pediatric Advisory Committee (PAC) is a committee of authorities knowledgeable in pediatric research, pediatric subspecialties, statistics, and/or biomedical ethics who advise and make recommendations to the FDA
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Rare Pediatric Disease Designation
Published by IRDiRC
Early Access SupportOrphan Drug DesignationPaediatric MedicineRare Paediatric Disease DesignationRegulatory AffairsThe FDA grants rare pediatric disease designation for diseases with serious or life- threatening conditions that affect people from birth to 18 years of age, that affect fewer than 200,000 people in the U.S.
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European Network of Paediatric Research at the European Medicines Agency
Published by IRDiRC
Early Access SupportEuropean Network of Paediatric ResearchOrphan DrugPaediatric MedicineRegulatory AffairsResearch and Drug DevelopmentThe European Network of Paediatric Research at the European Medicines Agency (Enpr- EMA) is a network of research networks, investigators and centres with recognised expertise in performing clinical studies in children. Enpr-EMA enables networking and collaboration with members from within and outside the European Union (EU), including academia and the pharmaceutical industry
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Potential for Synergy with Paediatric Regulation (+2 years of Market exclusivity)
Published by IRDiRC
Early Access SupportPaediatric MedicinePaediatric RegulationPotential for SynergyRegulatory AffairsPotential for synergy between EU Orphan (Regulation (EC) No 141/2000) & Paediatric Regulation (Regulations (EC) No 1901/2006 and 1902/2006)
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Paediatric Investigation Plans
Published by IRDiRC
Early Access SupportPaediatric Investigation PlanPaediatric MedicineRegulatory AffairsA paediatric investigation plan (PIP) is a development plan aimed at ensuring that the necessary data are obtained through studies in children, to support the authorisation of a medicine for children
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Paediatric Regulation
Published by EU
Early Access SupportEMA Paediatric RegulationOfficial JournalPaediatric MedicinePaediatric RegulationRegulatory AffairsThe Regulation aims to ensure that medicines for use in children are of high quality, ethically researched and authorised appropriately and improving the availability of information on the use of medicines for children. It aims to achieve this without subjecting children to unnecessary trials or delaying the authorisation of medicines for use in adults.
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