Overview of the Paediatric Investigation Plan (PIP) procedure, 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 course 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.