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Online Live Training Features

All sessions of this unique course online

Live interaction options between the delegates and trainer

Available via mobile, tablet or laptop

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Meet the training leader

  • Sue Rees
  • Pharmacovigilance Expert, Former EU QPPV
  • United Kingdom
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Course description

This practical course provides an in-depth understanding of signal detection, signal validation & assessment as well as signal communication. The series of talks, discussions & group exercises will bring clarifications about the regulation & methodologies for signal detection, what to consider in signal validation and prioritisation, how to notify regulatory agencies and avoid inspection findings related to signal management.

 

Key takeaways

Understand the regulations & guidance on signal management.

Get an overview of qualitative and quantitative methodologies for signal detection

Explore the role of social media in signal detection

Learn about signals of disproportionate reporting

Reveal what to consider in signal validation and prioritisation

Discuss in groups whether your signals are valid, what assessment you would do & next steps

Learn how signal management links with PSUR & Risk Management Plans

Get expert insights on signal communication

Understand implementation, oversight and governance of the signal management process in the company

Reveal potential inspection findings related to signal management and learn how to avoid them

Testimonials from courses led by Sue Rees

Ticket

Delegate Fee

from 1396 € Buy

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