概要

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.

特集トピック

- 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

参加対象

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.

学習目的

- 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.

申込書をダウンロード参加申し込み

EMA Paediatric Investigation Plans in-person training course

概要

Participant Testimonials

特集トピック

参加対象

学習目的

最新情報や機会を逃さないで