Paediatric Investigation Plans On-Demand Training
|
THE ONLY COURSE providing a full introduction to Paediatric Investigation Plans (PIPs) and the EU Paediatric Regulation!Register Here!
Description
This training course will provide a full introduction to Paediatric Investigation Plans (PIPs) and the EU Paediatric Regulation. Topics will be presented through interactive lectures and hands-on workshop training.
Learning Objectives
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