2018 European Forum for Qualified Person for Pharmacovigilance (QPPV)

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

Session Chair(s)

Peter De Veene, MD

GQPPV

MSD Belgium, Belgium

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)

Alternative Data sources for Signal Detection

Phil Tregunno

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

Deputy Director - Patient Safety Monitoring

Feedback to Signaling in Eudravigilance – Big Pharma Perspective

Yusuf Tanrikulu

Deutschland, Germany

Christina Strom Moller, MD, PhD

Sobi AB, Sweden

Head Global Pharmacovigilance &Patients Safety, QPPV