PHARMACOVIGILANCE

Pharmacovigilance Operations – Postmarketing

ICSR – individual case safety report

‘ICSR’ refers to an Individual Case Safety Reports which must be compiled for each instance of a suspected or confirmed adverse event and submission of such report to the Competent Authority (CA) of the Member State.

Expedited reports

Remaining compliant throughout all the changes to EU legislation can be a challenging endeavor for any company. This is particularly the case with Expedited Reporting – one of the pillars of all EU pharmacovigilance work.

Literature screening

Why is Screening of Literature Important?

PSUR / PBRER – Periodic Safety Update Report

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

Safety signals

Business-Critical Responses – Your Processing of Safety Signals