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.
Involving children in clinical research has always been fraught with controversy. We will explain the major historical events that have shaped this.
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.
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 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 new Clinical Trials Regulation will bring new changes to the approval processes for all clinical trials. We will explain how it affects paediatric trials.
Children are a vulnerable population, and they are protected by additional legislation. Learn how to navigate it.