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

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 PDCO and FDA requirements

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 Basel@DIAglobal.org