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Session 5: Signalling
Session Chair(s)
Mick Foy
Director of Delivery
Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
This session will explore the latest developments in signal detection activities in the EU and how the tools provided by the EMA and other data sources are used to support drug safety monitoring. There will be perspectives from PRAC, industry and the UK regulatory agency.
Speaker(s)
Use of other data sources
Charlotte Goldsmith
MHRA, United Kingdom
Signal Management Coordinator, Vigilance Intelligence and Research Group
Signal Management MetricsUseof EVDAS outputs by MAHs
David John Lewis, PhD
Novartis Pharma Gmbh, Switzerland
Head QPPV PRRC Office, Patient Safety & Pharmacovigilance