A French cohort ATU example
Companies who do not design or manufacture the devices have to use the term “manufacturer”.
EUDRAC held a 2-day pharmacovigilance inspection by the German Competent Authority (BfArM).
Risk Management Plan in revision 2 template
Periodic Safety Update Report (PSUR) in the European Union for a product which was not registered in the eXtended Medicinal Product Dictionary (XEVMPD).
Project management and regulatory function for a Centralised MAA
Obtainig CHMP’s agreement on a change in development plan.
PRIME application for an orphan drug