Introduction to Pharmacovigilance

Agenda

Day 1 Nov 10, 2015

9:00 AM — 10:00 AM

Session 1: Pharmacovigilance background and regulatory framework

10:00 AM — 11:15 AM

Session 2: Key concepts and definitions including exercises

11:15 AM — 11:30 AM

Coffee Break

11:30 AM — 1:00 PM

Exercises on Session 2 and Session 3: Reporting requirements for expedited ICSR

1:00 PM — 2:00 PM

Lunch Break

2:00 PM — 3:45 PM

Exercises on Session 3 and Session 4: Requirements for data quality in ICSRs

3:45 PM — 4:00 PM

Coffee Break

4:00 PM — 5:30 PM

Session 5: Coding, MedDRa; and Session 6: Data Privacy Protection

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