Paediatric Investigation Plans
This face-to-face training course will provide a full introduction to Paediatric Investigation Plans (PIPs) and the EU Paediatric Regulation. The course faculty are European-based leading experts
from European Medicines Agency and industry.
Topics will be presented through interactive lectures and hands-on workshop training.
- Definitions, Regulation, Guidelines
- PIP Lifecycle: Preparation, submission, modifications
- Global Paediatric Plan
- PIP Opinion
- Special issues: Pharmaceutical forms and formulations, non-clinical studies, clinical studies
Who should attend?
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.
- 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
- Understand expectations for Covid19 PIPs