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An agency of the European Union
A European Network of PaediatricResearch The Contribution of Regulators
Daniel BrasseurChair PDCO
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Paediatric Investigation Plans
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PDCO
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EMA
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What should the PDCO do?
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What should the PDCO do?
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To assist in which domains?
• Formulations
• Pre-clinical
• Methodology (design, statistics, extrapolation…)
• Special populations (neonates, …)
• Special products (vaccines, Blood products…)
• Specific fields (rare diseases, ATherapies…)
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What can PDCO offer?
Guidance (science for regulation)
Prioritise Needs & Products
Evaluate and assess paediatric projects intended to bring new or old drugs on the market (e.g PUMA)
Communicate with EMA on ‘ongoing’ Research (EudraCT)
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‘Guidance’ in the « pipe-line »
• Gluco-corticoid induced osteoporosis
• Pulmonary Hypertension
• Insomnia
• Schizophrenia
• Asthma
• Hepatitis C
• …
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PDCOevaluation
DG ResearchProject
PIP
DG Research
EMA
FundedProject
List
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PDCOevaluation
DG ResearchProject
PIP
DG Research
EMA
FundedProject
List
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PDCO
PIP
List
DG Research
EMEA
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PDCO
PIP
Project
List
DG Research
EMEA
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All together…
PDCO can work with the Network to define standard/models PIP (methodology, formulations, designs….) in defined areas where paediatric drug development takes place having in mind feasibility (ethics, access…)and perception of patients (families…)
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PDCO can offer ‘services’ to the system/networks
1/advice on methodology, formulations… guidingresearch and facilitating development with the view to register a paediatric drug…but
2/needs to receive input from all stakeholders to fit with relevance and reality
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