• • The Paediatric Regulation, Definitions, 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