Price (from): €6,000 / day
• 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.
About the training
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.
Understand the basic concepts and principles of signal detection
Describe how to apply these techniques within your company
Conduct signaling analyses on real-life data
Part 1: Background to Signal Detection
The need for signal detection
Approach to Signal Detection
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
Elements of case series analysis
Components of suggested analyses
How to characterize a suspected signal
Part 2: Signaling Examples
Signaling Case Studies
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
More trainings of the trainerImpact of the European Pharmacovigilance Legislation on International Companies US Drug Safety and FDA Inspection Readiness Introduction to Drug Safety – US and EU Requirements