‘ICSR’ refers to Individual Case Safety Reports which must be compiled for each instance of a suspected or confirmed adverse event and each reception of a report about one to the Competent Authority (CA) of the Member State.
Remaining compliant throughout all the changes to EU legislation can be a challenging endeavour for any company. This is particularly the case with Expedited Reporting – one of the pillars of all EU pharmacovigilance work.
This site uses cookies to personalise and customise your experience. No cookies collect personal or sensitive information. By clicking “I Accept", you consent to cookies in accordance with our cookie policy.
