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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