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Paediatric Investigation Plans

This on-demand course focuses on providing an introduction to Paediatric Investigation Plans (PIPs) and the EU Paediatric Regulation.

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概要

This on-demand training course will provide an introduction to Paediatric Investigation Plans (PIPs) and the EU Paediatric Regulation.

This on-demand course will take approximately 4 hours to complete.

特集トピック

- EU Regulation
- How to build the PIP
- Conditions/indications
- How to answer PDCO request for modification at Day 60
- Company interactions with PDCO
- Global Paediatric Plans
- PIP Opinion
- PIP modifications
- Changing the scope of the PIP
- Compliance check
- MAA validation
- Annual deferral reports and rewards
- Paediatric formulations
- Nonclinical studies
- Clinical development
- Modelling and simulation, extrapolation

学習目的

At the conclusion of this on-demand training course, participants will be able to:
- Describe the EU paediatric regulation
- Discuss the PIP approval procedure
- Identify the expectations and requirements from the Paediatric Committee (PDCO)
- Demonstrate how to prepare a PIP eligible for evaluation by PDCO
- Explain the modification of an agreed PIP procedure
- Describe the compliance check procedure
- Demonstrate an overview of procedures after initial PIP approval
- Prepare a global plan in compliance with EU, US and UK requirements

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