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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
QPPV, 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)
Phil Tregunno
Deputy Director - Patient Safety Monitoring, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Alternative Data sources for Signal Detection
Yusuf Tanrikulu
, Deutschland, Germany
Feedback to Signaling in Eudravigilance – Big Pharma Perspective
Christina Strom Moller, MD, PHD
Head Global Pharmacovigilance &Patients Safety, QPPV, Sobi AB, Sweden