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

This course will present signal detection and management in the framework of regulatory compliance as well as risk management and risk communication strategies.


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 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.

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:

  • Lead 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)  
  • Apply structured medical assessment to safety signal evaluation to ascertain which signals represent actual product risks
  • Design governance processes for signal detection, prioritization, evaluation, risk management, and communication
  • Integrate safety signal management into overall risk management

Contact us

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1.888.257.6457
+1.215.442.6100


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