Introduction to Signal Detection and Data Mining in Pharmacovigilance

Date(s) And Time(s):
Oct 7 2010 9:00AM - Oct 7 2010 5:30PM

Park Inn London, Russell Square
92 Southampton Row
United Kingdom


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.

Learning Objectives:

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

Target Audience:

• Pharmacovigilance (including QPPV)
• Clinical Development
• Risk Management
• Pharmacoepidemiology
• Information Technology
• Regulatory Affairs
• Quality and Compliance
• Legal

Event Code:

Contact Information:
DIA Europe
TEL.: +41 61 225 51 51
FAX: +41 61 225 51 52