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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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概览

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.

精选主题

    • 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

 

谁应该参加？

  • This training course is designed for professionals in regulatory affairs, clinical research, project management, toxicology, and product development.

  • Participants should preferably have a fair understanding of aspects of paediatric medicines development.

  • Level: Intermediate

      • 学习目标

      • 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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