Paediatric Clinical Trials in the EU: How to Overcome Regulatory and Ethical Challenges

There is a high need to get more medications authorized for paediatric use. To support this need, special regulations and funding opportunities are available in the EU. Learn how to navigate them.

“Paediatric research, globally and particularly within the European  Union, has taken on a new dimension, both from the demands of regulators, investigators, and patients (or their legal representatives). Effective treatment for adults is not always effective and safe for children.The e-book we have developed will give the reader from other regions an insight into the European Medicines Agency's information materials and the history of pediatric research and current strategies.”

Janis Skards

Chief Medical Officer
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In order to market a product for paediatric use, sponsors need to be familiar with the following frameworks, among others:

Paediatric Use Marketing Authorisation
Priority list of studies on off-patent paediatric medicinal products
Paediatric Investigation Plan

Our e-book will provide you with in-depth information on:

The historical background behind paediatric clinical trials

Involving children in clinical research has always been fraught with controversy. We will explain the major historical events that have shaped this.

The requirements to obtain a Paediatric Use Marketing Authorisation

A PUMA is granted for medications that have shown to be safe and effective for children. We will guide you through the steps required to obtain one.

The process to submit and obtain approval for a Paediatric Investigation Plan

All new medications seeking approval by the EMA now need to present a PIP or have grounds for an exemption. We will show you how to obtain it.

The available grants and organizations meant to help develop medicines for children

The EU now recognizes the importance of expanding the list of medicines that can be used in children. Learn more about the grants and mechanisms that can help you contribute.

The approvals needed for paediatric research under the new Clinical Trials Regulation

The new Clinical Trials Regulation will bring new changes to the approval processes for all clinical trials. We will explain how it affects paediatric trials.

The ethical considerations for paediatric clinical research

Children are a vulnerable population, and they are protected by additional legislation. Learn how to navigate it.