Introduction to Pharmacovigilance and Rules for Expedited Reporting of Individual Case Safety Reports (ICSRs) in Europe

Agenda

Day 1 May 13, 2014

9:00 AM — 10:00 AM

Pharmacovigilance background and regulatory framework

10:00 AM — 12:00 PM

Key concepts and definitions including exercises

12:00 PM — 1:00 PM

Reporting requirements for expedited ICSR

2:00 PM — 3:45 PM

Requirements for data quality in ICSRs

4:00 PM — 5:30 PM

Coding, MedDRa, Data Privacy Protection

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