Overview

Effective safety signal detection, evaluation, and management incorporates pharmacovigilance, biostatistics, information technology, medical, regulatory, and governance activities. Biopharmaceutical sponsors are expected by regulatory authorities to identify safety issues via analysis of all information available to them. As the amount of data has grown, so have tools and strategies to manage safety signals. Each data source and analytic strategy has inherent strengths and limitations. An understanding of these factors is a pre-requisite for an effective system of signal detection, prioritization, evaluation and decision-making. This virtual course will present signal detection, evaluation, and management in the framework of regulatory compliance as well as risk management and risk communication strategies. Outputs from signal detection systems will be the basis for hands-on exercises and discussions.

New to Signal Detection? We recommend participants have a firm working knowledge of signal detection and suggest the following online course to learn the basics prior to attending this advanced course.

Basics of Signal Detection and Pharmacoepidemiology eLearning module

What you will learn

Create an efficient, compliant, multidisciplinary process for signal management
Evaluate signals from all sources (including data mining) accouting for sources of bias and confounding
Develop a framework for determining when the evidence constitutes a reasonable probability of drug causality
Integrate data visualization and data mining within an overall system of product safety risk management
Discuss how regulatory authorities expect product safety data to be monitored from clinical development to post-marketing
Discuss new sponsor obligations for signal detection in EudraVigilance based on updates to GVP Module IX

Who should attend?

This course is designed for members of clinical safety and pharmacovigilance organizations who oversee, manage, or perform signal detection activities. The course will also benefit participants who make risk management decisions based on signal detection including professionals who work in:

Clinical safety and pharmacovigilance
Pharmacoepidemiology
Biostatistics
Clinical development
Regulatory affairs
Benefit-risk management
Information technology supporting pharmacovigilance activities

Learning objectives

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

Identify the components needed in the implementation of an integrated signal management project
Recognize the advantages of various data visualization tools
Identify strengths and limitations of specific data sources and methods for signal detection and evaluation
Interpret outputs from disproportionality methods (data mining)
Compare structured medical assessment to safety signal evaluation to ascertain which signals represent actual product risks
Define governance processes for signal detection, prioritization, evaluation, risk management and communication
Identify safety signal management to include overall risk management

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