by Ursula Tschorn | Jul 14, 2015
Summary of Product Characteristics (SmPC) sometimes also abbreviated as SPC
by Ursula Tschorn | Jul 14, 2015
Enterprise Resource Planning (ERP)
by Ursula Tschorn | Jul 14, 2015
Regulatory Information Management (RIM)
by Ursula Tschorn | Jul 14, 2015
Marketing Authorisation Holder (MAH)
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...
