EMA Signal Management Information Day

Agenda

Day 1 Oct 27, 2017

8:00 AM — 8:45 AM

REGISTRATION

8:45 AM — 9:00 AM

WELCOME NOTE

9:00 AM — 10:30 AM

Session 1: The New EudraVigilance system and implications for Signal Management in the EU network

10:30 AM — 11:00 AM

REFRESHMENT BREAK

11:00 AM — 12:30 PM

Session 2: EudraVigilance access by MAHs – Tools for Signal Detection and Validation

12:30 PM — 1:30 PM

SANDWICH LUNCH

1:30 PM — 3:00 PM

Session 3: Signal Detection and Management by Marketing Authorisation Holders

3:00 PM — 3:30 PM

REFRESHMENT BREAK

3:30 PM — 5:00 PM

Session 4: EudraVigilance data for safety monitoring of medicinal products

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