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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