Developing medicines for children is important, but requires special measures to be taken during clinical development in order to shield children from undue risk.
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.
The process of enrolling in clinical trials is carefully regulated, as is the way in which sponsors advertise clinical trials to prospective participants. Patients are screened and must give...
Clinical trial results are recorded in a clinical study report (CSR) in a prescribed manner; however, access to the CSR is usually limited. Summarised information from the CSR comes...
After Phase III of clinical studies, all the information on a medicin is collected and organised in a pre-determiend format (a dossier), which is then submitted to the regulatory...
Life-cycle management activities begin as soon as a medicine receives authorisation from the regulatory authorities. Research on the medicine continues in order to gather additional data on safety and...
Research Ethics Committees (RECs) evaluate the ethical acceptability of research before participants can be enrolled in a study. RECs are highly regulated, neutral bodies which operate according to standard...
Non-clinical studies can be performed at any time during the life-cycle of the product, testing the compound outside of humans. Non-clinical studies aim to identify candidate therapies with the...
