Overview

This introductory training course will review approaches to the implementation of signal detection and data mining as part of your pharmacovigilance operations. The requirement for companies to perform signal detection is mandatory in Europe and highly recommended in the US. Many simple techniques can be applied to the generation and review of potential signals, which can also be augmented by the application of sophisticated data mining algorithms.

Topics discussed will include signal identification and assessment, application of available regulatory guidance documents, review of data visualization tools to facilitate signal detection and evaluation, and the use of EU GVP Module IX to structure and organize a signal management process.

What you will learn

Why signal detection is needed
Regulatory requirements
Approaches to signal detection
Good Pharmacovigilance practices
Data mining fundamentals
Introduction to the Bayesian Confidence Propagation Neural Network (BCPNN)
Proportional Reporting Ratio (PRR)
Multi-item Gamma Poisson Shrinker (MGPS)
Signal detection strengthening and management
Signal detection process and operation
Risk management basics in the US and the EU

Who should attend?

Professionals who work in:

Clinical safety and pharmacovigilance
Pharmacoepidemiology
Regulatory affairs
Clinical development/Clinical sciences
Project Management

Learning objectives

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

Understand how the signal detection process is used to define the safety profile of a product
Define signal detection and differentiate the stages of a signal management system
Describe the regulations and guidance documents driving the practice of signal detection in US and EU
Discuss various methods of qualitative and quantitative signal detection and data mining
Recognize how signal management systems can be organized and implemented within their company

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Introduction to Signal Detection and Data Mining

Overview

What you will learn

Who should attend?

Learning objectives

Be informed and stay engaged.