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Signal Management in Pharmacovigilance

This course is not currently scheduled but may be offered at your company site.
Please contact Fleming for more information.

  • Dates – not available
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Signal Management in Pharmacovigilance

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online live

Training features

Fully online

All sessions of this unique course online

Live interaction

Live interaction options between the delegates and trainer

On any device

Available via mobile, tablet or laptop

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.

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Sue Rees | Fleming
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Sue Rees
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Brochure

Reveal the full schedule of the training as well as key topics, course objectives, key takeaways, special features, and the trainer bio!

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Signal Management in Pharmacovigilance online live training by Fleming_Agenda Cover
Signal Management in Pharmacovigilance online live training by Fleming_Agenda Cover
Signal Management in Pharmacovigilance online live training by Fleming_Agenda Cover
key training

Topics

Signal detection

Signal validation & assessment

Signal communication

Benefits of attending

  • Understand the regulations & guidance on signal management
  • Get an overview of qualitative and quantitative methodologies for signal detection
  • Be introduced to EVDAS and expectations on its use
  • 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

Very enlightening and enriching.
Livia Martins de AbreuEurofarma Laboratórios S/A
It was a great learning development opportunity – great leader and open to discussions.
Yael TroubAbbvie
It is a very rich and informative course, and Sue Reese has so vast knowledge of the topic.
Renata da Rocha MedeirosEurofarma Laboratorios S/A
This course opened my eyes to signal management and introduced me to different strategies how to evaluate signals. There was also plenty of time to ask questions and discuss topics as they came up during the course.
Jonas ErikssonSwedish Orphan Biovitrum AB
Great course during 3 days!
Jana TomovicEmmes
Informative, interactive highest quality course.
Ewa Musialik-WojewodzicGSK
Sue Rees was an excellent speaker and was very knowledgeable about the topic, the course was efficiently organised and allowed plenty of time to ask questions and discuss various topics
Sarah SeddonDrug Safety Executive, Wockhardt, UK
Complete course overviewing the key pharmacovigilance activities involved in the signal management process.
Alberto TremoladaSafety Medical Advisor, Recordati, Italy
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Training ticket

This course is not currently scheduled but may be offered at your company site.
Please contact Fleming for more information.

Online Live Stream
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1496€
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Contact us

Andrea Weber | Marketing Manager | Fleming
Linkedin
Andrea Weber
Sr. Manager for Pharma
Phone: +421 257 272 100
Email: event.inquiries@fleming.events

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