Overview

Overview of the Paediatric Investigation Plan (PIP) procedure and lifecycle, including in-depth discussion of specific scientific/regulatory issues in relation to PIPs will be discussed. Case-studies and instructor-led group work on specific cases will be presented.

This course will provide a full introduction to PIPs and the EU Paediatric Regulation.

The course faculty are European-based leading experts from EMA and industry. Topics will be presented through interactive lectures and hands-on workshop training.

What participants from previous courses say:
"One feels confident to take on PIP related tasks!"
"Congratulations for this programme! I enjoyed it a lot"
"Very good presenters, who responded to our questions"
"Very useful course. Will help me in practical cases very soon"

What you will learn

EU paediatric regulation
PIP lifecycle
How to get your PIP approved
PIPs after approval

Who should attend?

Professionals in regulatory affairs, clinical research, project management, toxicology, product development. Participants should preferably have a fair understanding of aspects of paediatric medicines development.

Level: Beginner/Intermediate

Learning objectives

At the conclusion of this course, participants should be able to:

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

Participants will complete a knowledge check at the end of the course and will be provided with feedback to ensure learning objectives are attained.

Program Committee

Mette Due Theilade Thomsen, PhD CEO
PIP Adviser, Denmark
Janina Karres, PhD Scientific Officer, Paediatric Medicines Office
European Medicines Agency, Netherlands

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