May 28th 2025
While randomization is required by regulatory bodies, it is up to the sponsor on how to conduct it.
January 21st 2021
New Pharmacovigilance, and New Inputs to Legislation
December 1st 2003Europe has a new system for pharmacovigilance for human medicines up and running. It's a data-processing network and database management system for dealing with Individual Case Safety Reports (ICSRs) in 18 countries-Iceland, Norway and Lichtenstein, in addition to the 15 European Union member states.