The Pharmacovigilance Risk Assessment Committee (PRAC) is the committee that is responsible for assessing all aspects of the risk management of medicines for human use.
This extraordinary CHMP meeting is organised to discuss emerging data with the sickle cell disease medicine Oxbryta (voxelotor).
This is tenth quarterly meeting of the Industry Standing Group (ISG).
EMA is initiating a new pilot programme for the expert panels to support manufacturers manufacturing and notified bodies certifying orphan medical devices with the challenges linked to generating clinical evidence for these devices in the premarket phase.
This is a hands-on training that covers user management, clinical trial life cycle, modifications, and responding to RFIs. Featuring a blended learning approach with on-demand, self-paced, and live virtual sessions.