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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)
Signaling Pilot EVDAS
Achint Kumar Gupta, DrMed, MD
Biogen Idec Ltd., United Kingdom
EU QPPV - Safety & Benefit-Riak Management
Risk Perception and Communication
Frederic Bouder, PhD
University of Stavanger, Norway
Professor in Risk Management
Communication of Identified Signals: Global Perspective
Magnus Ysander, MD
AstraZeneca, Sweden
EU & UK QPPV & Head Pharmacovigilance Excellence
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