Training Course on Introduction to Signal Detection and Data Mining in Pharmacovigilance

The World Health Organisation (WHO) defines the term Signal as “reported information on a possible causal relationship between an adverse event and drug, the relationship being unknown or incompletely documented previously”. Adverse Drug Reactions (ADRs) may be identified as Signals for clinical and / or quantitative reasons. This course will cover the fundamentals of classical and statistical signal detection and data mining in Pharmacovigilance.

At the conclusion of this course, participants should be able to:

• Explain and apply the basic concepts and principles of signal detection in Pharmacovigilance
• Explain the role and differences of classical and statistical signal detection in the ongoing safety surveillance of medicinal products
• Outline how to apply signal detection within their function based on the possibilities and limitations of methodology and data
• Employ data mining techniques to analyse large volumes of adverse event report data
• Discuss key messages from the European Medicines Agency Guideline on the uses of statistical signal detection methods in the Eudravigilance Data Analysis System