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Joint MHRA/DIA Excellence in Pharmacovigilance

This course is designed to provide a firm grounding in key aspects of European Clinical Pre- and Post-Marketing Safety regulatory requirements.


TOPIC 4: SIGNAL DETECTION AND SIGNAL MANAGEMENT. SESSION 1: Introduction to Signal Detection

Session Chair(s)

Gaby L. Danan, MD, PhD

Gaby L. Danan, MD, PhD

  • Pharmacovigilance Expert
  • GLD, France
Phil  Tregunno

Phil Tregunno

  • Group Manager, Vigilance, Intelligence and Research Group
  • 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

Introduction to Signal Detection

Phil Tregunno

  • Group Manager, Vigilance, Intelligence and Research Group
  • Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom

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