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...
Special considerations are necessary when prescribing medicines in special populations, such as children, the elderly, pregnant and breastfeeding women, and patients with renal (kidney) or hepatic (liver) impairment.
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.
Some groups within the general population of a clinical study may require special study, due to the particular risks, benefits, or treatment requirements associated with them
