Overview

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.

Featured topics

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.

Level: Intermediate

Learning objectives

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

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