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Renaissance London Heathrow Hotel

Oct 10, 2018 8:00 AM - Oct 11, 2018 4:30 PM

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

QPPV, 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

Phil Tregunno

Deputy Director - Patient Safety Monitoring, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom

Alternative Data sources for Signal Detection

Yusuf  Tanrikulu

Yusuf Tanrikulu

, Deutschland, Germany

Feedback to Signaling in Eudravigilance – Big Pharma Perspective

Christina  Strom Moller, MD, PHD

Christina Strom Moller, MD, PHD

Head Global Pharmacovigilance &Patients Safety, QPPV, Sobi AB, Sweden

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