A very important result from the EUPATI project was the development, broad consultation and final release of guidances on the best approach to interaction of patients with pharmaceutical industry-led...
The European Patients’ Academy (EUPATI) guidance document on patient involvement in regulatory processes aims to support the integration of patient involvement across the entire process.
This article explores patient involvement in scientific regulatory committees in the EU, specifically in the activities of the European Medicines Association (EMA).
Before a medicinal product can be marketed and sold, a marketing authorisation must be obtained from the relevent National Competent Authorities. The marketing authorisation application process can take one...
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...
