Why a purposeful approach to the PIP pays dividends

Efficiently adapting regulatory compliance requirements from the Food and Drug Administration (FDA) to the European Medicines Agency (EMA) across nonclinical, clinical, and quality sections of the Paediatric Investigation Plan (PIP) is essential. While the FDA has strict requirements around studies in children – through the initial Paediatric Study Plan (iPSP) and, more recently, the Paediatric […]

Understanding what the PIP development plan entails

During our conversations with clients from the United States, we often find there is a misunderstanding about the paediatric investigation plan (PIP). Many see the PIP as simply a document that is part of the clinical trial application process or marketing authorisation application interactions with the European Medicines Agency (EMA). This confusion stems from the […]

How sponsors of orphan drugs can take advantage of paediatric expertise at the PDCO

Rare diseases raise a critical planning consideration for sponsors: how to manage the inclusion of a paediatric population. This can be particularly challenging due to factors such as limited patient numbers, ethical considerations in trial design for children, and the need for age-appropriate formulations. Around 75% of rare diseases largely affect a paediatric population, which […]