概览

This 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.

Participant Testimonials

Very practical and interactive, the best training I attended in a long time.

精选主题

- 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

谁应该参加？

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.

学习目标

- 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

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Paediatric Investigation Plans

概览

Participant Testimonials

精选主题

谁应该参加？

学习目标

Digital Learning Catalog

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