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Session 5: Signal Detection and Risk Management: What's Next?
Session Chair(s)
Gemma Jimenez Sese
Senior Director, Deputy EU QPPV, AstraZeneca, Spain
Magnus Ysander, MD
EU & UK QPPV & Head Pharmacovigilance Excellence, AstraZeneca, Sweden
Signal detection and risk management have been continuously evolving in recent years. In the EU there are new requirements for signal detection in EVDAS and steps towards more strict definitions of risk. At the same time emerging legislation from global markets bring new obligations for signal notification and risk management plans. What have we learnt from the signal pilot? How can we ensure consistency of risk definitions internationally? Finally, are we communicating signals and risks appropriately with the patient in mind?
Speaker(s)
Achint Kumar Gupta, DrMed, MD
EU / UK QPPV , Incyte, Netherlands
Signaling Pilot EVDAS
Frederic Bouder, PhD
Professor in Risk Management, University of Stavanger, Norway
Risk Perception and Communication
Magnus Ysander, MD
EU & UK QPPV & Head Pharmacovigilance Excellence, AstraZeneca, Sweden
Communication of Identified Signals: Global Perspective