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Renaissance London Heathrow Hotel

10 oct 2018 8:00 a.m. - 11 oct 2018 4:30 p.m.

Bath Road, Hounslow, Middlesex, TW6 2AQ, United Kingdom

2018 European Forum for Qualified Person for Pharmacovigilance (QPPV)

Session 5: Are We Looking at the Right Thing in the Right Place? - EV Signalling Experience

Session Chair(s)

Peter  De Veene, MD

Peter De Veene, MD

GQPPV

MSD Belgium, Belgium

Winrich  Rauschning, DrMed, MD, MBA

Winrich Rauschning, DrMed, MD, MBA

QPPV

Biolitec Pharma, Germany

In October 2018 signaling in EV will have been mandatory for about 7 months. Experts from EMA, large and small pharma will review their experience and discuss points like: Are we looking at the right thing? Are we identifying signals in a timely manner? How complementary is this approach to established sources and methods?

Speaker(s)

Phil  Tregunno

Alternative Data sources for Signal Detection

Phil Tregunno

Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom

Deputy Director - Patient Safety Monitoring

Yusuf  Tanrikulu

Feedback to Signaling in Eudravigilance – Big Pharma Perspective

Yusuf Tanrikulu

Deutschland, Germany

Christina  Strom Moller, MD, PhD

Christina Strom Moller, MD, PhD

Sobi AB, Sweden

Head Global Pharmacovigilance &Patients Safety, QPPV

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