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SIGNAL DETECTION AND MANAGEMENT: CAN YOU WHISTLE?
Session Chair(s)
Phil Tregunno
Deputy Director - Patient Safety Monitoring
Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
The session will present signal detection recommendations from the collaborative Innovative Medicines Initiative (IMI) PROTECT Project and discuss the key principles of signal management in the EU. Over the course of the past 5 years, IMI PROTECT has conducted research across multiple partners to explore various aspects of statistical signal detection. Its results are already beginning to shape changes in the approach to signal detection within the EU Network. This session will provide a whistle-stop tour of those recommendations, and key principles for signal management in the EU.
Speaker(s)
Introduction to PROTECT Research and Recommendations for Statistical Signal Detection
Antoni Wisniewski, MSC
AstraZeneca, United Kingdom
Lead, Safety Surveillance Systems, Global Regulatory Affairs
Choice of Granularity for Statistical Signal Detection: When and how to group adverse events
Niklas Noren, PHD, MSC
Uppsala Monitoring Centre (UMC) , Sweden
Chief Science Officer
Statistical Signal Detection for Spontaneous Reports: Which method to use?
Suzie Seabroke, PHD, MSC
MHRA, United Kingdom
Senior Pharmacoepidemiologist, Vigilance and Risk Management Division
The Signal Management Process in the European Pharmacovigilance Network - key principles, transparency, process optimisation, and interface with stakeholders
Georgy Genov, MD
European Medicines Agency, Netherlands
Head of Pharmacovigilance Office