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Hilton London Canary Wharf

2018年4月10日 (火) 午前 8:00 - 2018年4月11日 (水) 午後 4:30

South Quay, Marsh Wall, London, E14 9SH, United Kingdom

Paediatric Investigation Plans (PIP)

This intermediate course will provide a full introduction to PIPs and the EU Paediatric Regulation.

概要

This course will provide a full introduction to PIPs and the EU Paediatric Regulation. The course faculty are European-based leading experts from EMA and industry. Topics will be presented through interactive lectures and hands-on workshop training.

何を学ぶか

  • EU paediatric regulation
  • PIP lifecycle
  • How to get your PIP approved
  • PIPs after approval

参加対象

Professionals in regulatory affairs, clinical research, project management, toxicology, product development.

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

Level: Intermediate

学習目的

At the conclusion of this 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

Participants will complete a knowledge check at the end of the course and will be provided with feedback to ensure learning objectives are attained.


Plan Your Team's Professional Development

Why not take advantage and train your whole department (or even across different departments!) and benefit from increased:

  • Focus
  • Flexibility
  • Convenience
  • Cost Effectiveness

For more information please contact EMEA@DIAglobal.org

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