Overview

Effective safety signal detection and management incorporates pharmacovigilance, information technology, medical, regulatory, and governance activities. Biopharmaceutical sponsors are expected 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 prerequisite for an effective system of signal triage, prioritization, evaluation and decision-making. This basic to intermediate level course will present signal detection 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 practical exercises and discussions.

What you will learn

Create an efficient, compliant, multidisciplinary process for signal detection and management
Integrate data mining within an overall system of product safety risk management
Read and interpret outputs from automated data mining analyses
Prioritize and evaluate signals from all sources (including data mining)
Understand how regulatory authorities use data mining to monitor product safety

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
Regulatory affairs
Benefit-risk management
Information technology supporting pharmacovigilance activities

Learning objectives

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

Lead the implementation of an integrated signal detection and management project
Identify strengths and limitations of specific data sources for signal detection and evaluation
Interpret outputs from automated quantitative signal detection methods (data mining results)
Discuss setting up triage and prioritization procedures for safety signals
Apply structured medical assessment to safety signal evaluation
Design governance processes for signal escalation, decision-making, action and communication
Integrate safety signal management into overall risk management
Anticipate regulatory responses to data mining results

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Advanced Signal Management - Detection, Evaluation, and Decision-Making

Overview

What you will learn

Who should attend?

Learning objectives

Be informed and stay engaged.