Pharmacovigilance Operations – Postmarketing

Case processing (ICSRs)

‘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.

Expedited reports

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.

PSUR / PBRER – Periodic Safety Update Report

Periodic safety update reports (PSUR) are required for all products that have marketing authorisation in the EU.

Literature screening

Why Are Correct Screening Procedures So Important?

Safety signals

Business-Critical Responses – Your Processing of Safety Signals