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Holiday Inn London Kensington Forum

Sep 17, 2015 8:00 AM - Sep 18, 2015 5:00 PM

97 Cromwell Road, London, SW7 4DN, United Kingdom

Paediatric Investigation Plans (PIP)

Overview

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.

Program Committee

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

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Ways to register

Registration fee includes refreshment breaks, lunches and training course material.

This course has limited capacity. Register early!

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