Trainer Booking
Log in Sign up

Signal Detection Training Course

by Steve Jolley

Languages: English

Price (from): €6,000 / day

Share Share

About the trainer:

•    Steve Jolley is a subject matter expert in all areas of global safety compliance and signal detection and is a frequent speaker at leading industry events with FDA, EMA, and MHRA on the topics of auditing and signaling
•    Steve has 30 years’ experience in drug safety & pharmacovigilance and has worked with over 200 clients worldwide. He holds degrees in mathematics and computer science from Cambridge University, England. 
•    He is an Adjunct Professor at Rutgers University and teaches part of their Master's degree in Drug Safety and Pharmacovigilance. 
•    Steve has conducted over 200 audits for pharmaceutical companies in the US, EU, India, and Japan in order to prepare for both FDA and EU pharmacovigilance inspections.
•    Steve was elected chairperson of the DIA Clinical Safety and Pharmacovigilance steering committee for North America.  He is a member of DIA’s training faculty and instructs as part of DIA’s Clinical Safety and Pharmacovigilance Certificate Program.


Please login to send a message

Signal Detection Training Course by Steve Jolley

About the training

#signal detection   #signaling examples

This training course will review approaches to the implementation of signal detection as part of your pharmacovigilance operations. The requirement for companies to perform signal detection is mandatory in Europe and highly recommended in the US.  Many simple techniques can be applied to the generation and review of potential signals.

Topics discussed will include signal assessment, use of signal triage algorithms, compliance with FDA and EMA guidance as specified in FDA’s “Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment” and GVP Module IX, and the timing and frequency of signal detection, triage, and data mining runs.

Learning outcomes

Signal Detection

Understand the basic concepts and principles of signal detection

How to apply

Describe how to apply these techniques within your company

Signaling Analyses

Conduct signaling analyses on real-life data


  • Part 1: Background to Signal Detection

  • Pharmacovigilance

  • The need for signal detection

  • Regulatory Requirements

  • Approach to Signal Detection

  • Company Characterization

  • Premise for Signal Detection

  • Importance of astute clinical perspective

  • Danger of over-reliance on technology

  • Signal Detection Hierarchy

  • Layered approach to signaling

  • Statistical versus medical significance

  • Signaling Analyses specified by Good Pharmacovigilance Practices

  • Detailed characteristics

  • Elements of case series analysis

  • Recommended Approach

  • Components of suggested analyses

  • How to characterize a suspected signal

  • Quiz

  • Part 2: Signaling Examples

  • Signaling Case Studies

  • Data Flow

  • Recommended data elements to be obtained prior to analysis

  • Typical PSUR data elements

  • Analysis by MedDRA System Organ Class

  • Analysis by MedDRA Preferred Term

  • Analysis by Age Range

  • Analysis by Sex

  • Analysis by Country

  • Analysis by Time to Onset

  • Analysis by Treatment Duration

  • Analysis by Concomitant Medications

  • Analysis by Dechallenge/Rechallenge

  • Describe signal and relate to prior signaling exercises

  • Define correlations found via prior signaling exercises

  • Quiz

Main benefits

  • #Wide collection of the biggest experts
  • #Filters for all kinds of needs
  • #User friendly platform
  • #Fast and cheap
  • #Highest level of proficiency