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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.

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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.

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Literature screening

Why Are Correct Screening Procedures So Important?

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PSUR / PBRER – Periodic Safety Update Report

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

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Safety signals

Business-Critical Responses – Your Processing of Safety Signals

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