by Ursula Tschorn | Jul 13, 2015
Pharmacovigilance Risk Assessment Committee (PRAC)
by Ursula Tschorn | Jul 13, 2015
Pharmacovigilance System Master File (PSMF)
by Ursula Tschorn | Jul 13, 2015
Periodic Safety Update Report (PSUR) The objective of the PSUR is to present a comprehensive and critical analysis of the risk-benefit balance of the product taking into account new or emerging safety information in the context of cumulative information on risk and...