MDM

Master Data Management (MDM) is critical for IDMP compliance In matching IDMP´s required data with customer´s data there will be several systems identified which hold IDMP relevant data. In case of Marketing Authorisation Holders (MAHs) this will be...

PSUR

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...