OVERVIEW

Paediatric Investigation Plans (PIP) is organized by Drug Information Association (DIA) and will be held from Nov 17 - 20, 2025.

Description:
This training course will provide a full introduction to Paediatric Investigation Plans (PIPs) and the EU Paediatric Regulation. The course faculty are European-based leading experts from European Medicines Agency and industry. Topics will be presented through interactive lectures and hands-on workshop training.

Learning objectives:

  • 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 EU, US and UK requirements

Featured topics:

  • The Paediatric Regulation, Definitions, Guidelines
  • PIP Lifecycle: Preparation, submission, modifications
  • Global Paediatric Plan
  • PIP Opinion
  • Special issues: Pharmaceutical forms and formulations, non-clinical studies, clinical studies

KEY DATES

Event Start Date
17 Nov, 2025
Event Start Date
Event End Date
20 Nov, 2025
Event End Date
Credits

Continuing Education:
All DIA training courses have been awarded a PharmaTrain Centre Recognition.
PharmaTrain Federation is a not for profit organisation that started its activities as an IMI (Innovative Medicines Initiative) European Project. Its mission is to drive implementation of globally recognized high-level standards for postgraduate education and training in Medicines Development. To that aim, the Federation is assessing Continuous Professional Development (CPD) Courses and Course Providers around the world that deserve recognition.

The Swiss Association of Pharmaceutical Professionals (SwAPP) and the Swiss Society for Pharmaceutical Medicine (SGPM) have accredited this training course with 10.50 credits.
Special rates available for SwAPP and SGPM members.

NameCredit TypeMax CreditsCEU
PIP, 17-20 Nov 2025, 13:00-17:00 CET, Virtual LiveSWAPP/SGPM10.500.000

Statement of Credit:
Please note: Most EU countries accept direct submission, by the participant, of training courses, conferences and other educational opportunities with the aim of obtaining CPD (Continuous Professional Development) points. Please do not hesitate to contact DIA directly if you need any further documentation (e.g. detailed program, certificate of completion, etc.) to conclude your submission.

  • 10.5 Credits
  • TARGET AUDIENCE

    Clinical ResearchersRegulatory affairsPediatricsClinical Toxicologists

    SPECIALITIES

    Pediatrics

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