2nd Periodic Safety Update Report Information Day

Agenda

Day 1 Apr 29, 2014

8:00 AM — 8:30 AM

REGISTRATION

8:30 AM — 8:45 AM

WELCOME NOTE

8:45 AM — 10:15 AM

Session 1 - 1

10:15 AM — 10:40 AM

COFFEE BREAK

10:40 AM — 11:40 AM

Session 1: Technical and procedural aspects of PSUR submissions and the PSUR single assessment

11:40 AM — 12:30 PM

Session 2 - 1

12:30 PM — 1:15 PM

SANDWICH LUNCH

1:15 PM — 2:00 PM

Session 2 -2

2:00 PM — 3:30 PM

Session 3 - 1

3:30 PM — 4:00 PM

COFFEE BREAK

4:00 PM — 5:00 PM

Session 3: Periodic Benefit Risk Evaluation Reporting in practice

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