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 […]