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NH SCHIPHOL AIRPORT

Sep 18, 2019 8:00 AM - Sep 19, 2019 5:00 PM

Kruisweg 495 , 2132 NA Hoofddorp , Netherlands

Paediatric Investigation Plans (PIP) training course

This interactive training course for an intermediate level audience covers all aspects of a PIPs lifecycle, how to prepare for it, how to get it approved, and what to consider after approval.

Overview

ADD TO CALENDAR

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 you will learn

  • EU paediatric regulation
  • PIP lifecycle
  • How to get your PIP approved
  • PIPs after approval
  • Global peadiatric plan

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: Intermediate

Learning objectives

At the conclusion of this course, participants will 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
  • Prepare a global plan in compliance with PDCO and FDA requirements

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

Plan Your Team's Professional Development

Why not take advantage and train your whole department (or even across different departments!) and benefit from increased:

  • Focus
  • Flexibility
  • Convenience
  • Cost Effectiveness

For more information please contact Basel@DIAglobal.org

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