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TOPIC 4: SIGNAL DETECTION AND SIGNAL MANAGEMENT
Session Chair(s)
Gaby L. Danan, MD, PHD
Pharmacovigilance Expert, GLD, France
Phil Tregunno
Deputy Director - Patient Safety Monitoring, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
New safety signals may emerge at any time following product launch and must be evaluated for relative risk, medical importance, and likelihood of occurrence. This session will provide approaches to signal detection using quantitative methods illustrated in a workshop with examples as well as general considerations on signal management in the EEA.
Speaker(s)
Phil Tregunno
Deputy Director - Patient Safety Monitoring, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Introduction to Signal Detection
Phil Tregunno
Deputy Director - Patient Safety Monitoring, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Signal Management in the European Union: Regulatory Network Perspective
Jan Petracek, MD, MSC
CEO, iVigee Services a.s., Czech Republic
Signal Management in the European Union: Industry Perspective
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