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