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

Venue: Novotel Berlin-Mitte

Location: Berlin, Select state..., Germany

Event Date/Time: May 07, 2012 End Date/Time: May 08, 2012
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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:

Professionals who work in:

Pharmacovigilance (including QPPV)
Clinical Development
Risk Management
Information Technology
Regulatory Affairs
Quality and Compliance
For professionals with 2-3 years of experience in pharmacovigilance this course will be at a beginner level; professionals from other areas, or with less experience, will find this course more advanced.

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