A Paediatric Investigation Plan (PIP) must be submitted in order to support a medicine's authorisation for use in children. The PIP undergoes a review process and ensures that paediatric...
Off-label use of a medicine is the use of an authorised medicine by a healthcare professional to treat a patient in a way not covered by the Marketing Authorisation...
Developing medicines for children is important, but requires special measures to be taken during clinical development in order to shield children from undue risk.
Special considerations must be taken into account in the development of paediatric medicine, including in terms of research and trial design and ethical concerns.
Paediatric medicine development requires careful planning and decision making. Legislation in the EU mandates that paediatric medicine development should occur early in the medicine development process.
Small populations present ethical and practical challenges to organising clinical trials. Small populations include groups with rare diseases or specific sub-types of common diseases, children, and the elderly.
