EMA Information Day on Services and Systems in Pharmacovigilance

This event will provide marketing-authorisation holders with information on the development of the enhanced systems, helping them prepare for the business change to come.

Agenda

Day 1 Dec 07, 2015

8:00 AM — 8:45 AM

Registration

8:45 AM — 9:15 AM

Key Note

9:15 AM — 10:30 AM

Session 1: Adverse Reaction Reporting and Analysis, EudraVigilance System Changes to Come

10:30 AM — 11:00 AM

Coffee Break

11:00 AM — 12:15 PM

Session 1 continued: Adverse Reaction Reporting and Analysis, EudraVigilance System Changes to Come

12:15 PM — 1:00 PM

Sandwich Lunch

1:00 PM — 2:00 PM

Session 2: PSUR Repository – Achievements and Next Steps

2:00 PM — 3:15 PM

Session 3: EMA Service of Medical Literature Monitoring for Reports of Suspected Adverse Drug Reactions

3:15 PM — 3:45 PM

Coffee Break

3:45 PM — 5:00 PM

Session 4: Article 57 Database and How Data in Medicines is Used for Pharmacovigilance

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EMA Information Day on Services and Systems in Pharmacovigilance

Agenda

Be informed and stay engaged.