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Organiser: DIA

This virtual live training course covers essential concepts of signal detection and signal management and provides guidance on how to apply these concepts at participants' function and their organisation, including the data mining techniques for large volume ADR data analysis.

This virtual live training course covers essential concepts of signal detection and signal management and provides guidance on how to apply these concepts at participants' function and their organisation, including the data mining techniques for large volume ADR data analysis.

The entire course is in line with the latest guidelines on EU Good Pharmacovigilance Practices (GVP): Module IX – Signal management (rev. 1), Commission Implementing Regulation (EU) No. 520/2012, CIOMS VIII and relevant EMA guidelines.

This training is primarily developed based on EU legislation, but it also covers regulatory expectations for signal management in the US, Switzerland, Canada, Australia, and few other countries.

Participants benefit from the hands-on experience of trainers who have worked for many years in signalling activities and are ready to not only explain the legislation, but also provide personal experience and most commonly followed practices that are often considered as industry standards.

Featured Topics:

  • Signal Detection – Theory, methods, and data mining
  • Practical exercise on signal detection – analyse and discuss an article
  • Practical exercise on data mining methods – how to calculate RRR, ROR, PRR
  • Proactive and predictive signal detection
  • Use of automation and AI
  • Signal Management – Detection, validation, confirmation, analysis and prioritisation, assessment, and recommendation for action
  • Signaling exercise in PSUR review – data visualisation and analysis
  • Regulatory expectations in the EU, US, Switzerland, Canada, Australia etc.
  • Exercise on signal management – manage information from PRAC
  • EVDAS introduction and implementation in signal management
  • Strategy for implementation of signal management process in your own organisation (covering both small and large companies)
  • Exercise on signal management processes – propose and discuss the most appropriate signal management procedure for various types of organisations

Learning Objectives:

  • Apply the essential concepts and principles of signal management in PV and implement or improve this process in their own organisation
  • Compare different approaches to signal management that are followed by various organisations
  • Implement EVDAS into signal management process
  • Identify the regulatory expectations at different geographic regions

 

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