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European Medicines Agency

16 mar 2018 8:00 a.m. - 16 mar 2018 4:45 p.m.

30 Churchill Place, Canary Wharf, London, E14 5EU, United Kingdom

EMA EudraVigilance & Signal Management Information Day

SESSION 4: SIGNAL MANAGEMENT (PART 2)

Session Chair(s)

Georgy  Genov, MD

Georgy Genov, MD

Head of Pharmacovigilance Office

European Medicines Agency, Netherlands

Menno  Van Der Elst, PHARMD, PHD

Menno Van Der Elst, PHARMD, PHD

Head of EU Committees Department

MEB, Netherlands

The signal management session will continue with a presentation on the processes put in place by a marketing authorisation holder involved in the signal management pilot. Signal management key performance indicators (KPIs) from an industry perspective will be also discussed. The session will conclude with a dedicated question and answer session for which participants are invited to send questions by 23 February 2018 to emaevents@diaglobal.org

Speaker(s)

Magnus  Ysander, MD

MAHs processes as part of the signal management pilot

Magnus Ysander, MD

AstraZeneca, Sweden

EU & UK QPPV & Head Pharmacovigilance Excellence

David John Lewis, PHD

Signal Management KPIs from an industry perspective

David John Lewis, PHD

Novartis Pharma Gmbh, Switzerland

Former Head QPPV PRRC Office, Patient Safety & Pharmacovigilance

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