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European Medicines Agency

Nov 05, 2026 8:00 AM - Nov 06, 2026 5:00 PM

Domenico Scarlattilaan 6, 1083 HS Amsterdam, Netherlands

EMA Paediatric Investigation Plans in-person training course

THE ONLY EMA IN-PERSON TRAINING COURSE providing full introduction to Paediatric Investigation Plans (PIPs) and the EU Paediatric Regulation!

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Overview

This specialised hands-on course provides a full overview on the EU Paediatric Regulation and Paediatric Investigation Plans (PIPs). Designed and delivered by experts from the European Medicines Agency and industry, this programme offers an exceptional opportunity to learn directly from regulators and experienced professionals.

Through interactive lectures, real-world case discussions, and practical workshop sessions, you'll build the knowledge and confidence needed to navigate paediatric regulatory requirements effectively to prepare a comprehensive submission. Whether you're new to paediatric drug development or looking to deepen your expertise, this course provides the essential foundation for success.

 

 

 

Participant Testimonials

Very practical and interactive, the best training I attended in a long time.

Featured topics

    • The Paediatric Regulation, Definitions, Guidelines
    • PIP Lifecycle: Preparation, submission, modifications
    • Global Paediatric Plan
    • PIP Opinion
    • Scientific content: Pharmaceutical forms and formulations, non-clinical studies, clinical studies, modelling and simulation, extrapolation

Who should attend?

This training course is designed for professionals in regulatory affairs, clinical research, project management, planning to be involved in paediatric development.

 

The course is open to participants working in industry, medicines regulatory authorities, academia and clinical trial researchers.

 

Level: Intermediate.

Learning objectives

    • Explain the EU Paediatric Regulation and its role in guiding paediatric medicine development.
    • Describe the full PIP approval pathway, from initial submission to final agreement.
    • Understand the expectations of the Paediatric Committee (PDCO) and the key elements they assess in a PIP.
    • Prepare a high quality PIP that meets PDCO requirements and is ready for formal evaluation.
    • Explain how to request and manage modifications to an agreed PIP.
    • Navigate the compliance check process.
    • Summarise the procedures that follow initial PIP approval.
    • Develop a global paediatric development plan aligned with regulatory requirements across the EU, US, and UK.

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