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

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

• 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