Pharmacovigilance Training Online
Choose from 4 GPvP Online Courses

Pharmacovigilance 4 - Signalling and Risk Assessment

Module 4 of 4 - Pv Signalling & Risk Assessment Course

The Pharmacovigilance Signalling & Risk Assessment course is recommended if you are involved in drug safety, clinical trials, pharmacoepidemiology and risk management. The Pharmacovigilance Signalling & Risk Assessment course covers key components of signal detection, including; definitions, objectives, examples, FDA risk management constituents, EU Signalling requirements and data mining principles. Each of these factors are crucial for a company to ensure that they match legislation – one of signalling and risk management’s primary objectives is to understand and manage the risk profiles of drugs to help avoid hugely expensive and damaging drug withdrawals. Pharmacovigilance Signalling & Risk Assessment is a great addition to your knowledge in pharmacovigilance when combined with The Pharmacovigilance Audit course. The course contains interactive mini exams at the end of each chapter to help re-inforce learning. Updated March 2020.

  • Average study time:
    study time

    3 hrs

  • Personal development points (CPD):

    3 points

  • Price:


Please enter the number of licences required.

Course Details

This course comprehensively explains signalling and risk assessment in Pharmacovigilance, including an overview of data mining, signal detection and its requirements across European and American markets. Keeping products on the market without interruption becomes more essential with the reduced pipeline of drugs in development. Successful navigation of drug safety and pharmacovigilance are keys to product longevity, consumer confidence and regulatory compliance. This module will provide you with a strong foundation of knowledge on pharmacovigilance and drug safety.

Benefits for you

  • CPD Points - Gain Continuing Professional Development (CPD) Points, accredited by The Faculty of Pharmaceutical Medicine of the Royal College of Physicians of the United Kingdom. These can be used to count towards the distance learning element of any scheme that comes under the umbrella of The Academy of Medical Royal Colleges or any other scheme for which there is mutual recognition.
  • Certification - Receive a personal certificate to show your subject knowledge on course completion.
  • Affordable - You get excellent value through our cost-effective prices. We can also offer you group discounts on larger purchases.
  • Flexibility - The course saves you time through the convenience of online availability. This lets you complete the interactive course at your own comfort.
  • Keep Up to Date - You will stay up to date with any legislative changes in pharmacovigilance as our training courses are constantly monitored, reviewed and updated.
  • Learn from Industry Experts - The course content has been developed to ensure that you comply with pharmacovigilance legislation through the application of learning outcomes. The course is written by Steve Jolley, who is a chairperson for the Drug Information Association (DIA)

Course Syllabus

1. Learning Objectives for this Module

  • 1.1 Learning Objectives for this Module 

2. Background to Signal Detection 

  • 2.1 What is Pharmacovigilance? 
  • 2.2 What is a Signal? 
  • 2.3 Need for Signal Detection 
  • 2.4 Increased Withdrawals (1998-2001)
  • 2.5 Mini exam 

3. Reason for Change 

  • 3.1 Reason for Change 
  • 3.2 Rezulin Withdrawal 
  • 3.3 Baycol Withdrawal 
  • 3.4 The Cost of Failure
  • 3.5 Mini exam 

4. Legalities 

  • 4.1 FDA Risk Management Components 
  • 4.2 FDA Amendment Act (FDAAA) 
  • 4.3 European Signalling Requirements 
  • 4.4 GVP Module IX 
  • 4.5 EudraVigilance Monitoring
  • 4.6 Mini exam 

5. Signal Detection Objectives & Key Components 

  • 5.1 Signal Detection Objectives & Key Components 
  • 5.2 AE Incidence Rate 
  • 5.3 Numerator (AEs) 
  • 5.4 Denominator (Patient Exposure) 
  • 5.5 Rates 
  • 5.6 Premise 
  • 5.7 Need for the “Prepared Mind” 
  • 5.8 CIOMS VIII Report 
  • 5.9 Signal detection hierarchy
  • 5.10 Mini exam 

6. Signalling Analyses 

  • 6.1 Signalling Analyses 
  • 6.2 Approach to Signal Detection – Small Companies 
  • 6.3 Approach to Signal Detection – Large Companies 
  • 6.4 Data extraction and visualization 
  • 6.5 Data flow 
  • 6.6 PSUR prior to analysis 
  • 6.7 Sector map by SOC 
  • 6.8 Sector Map by PT 
  • 6.9 Analysis by Cause of Death 
  • 6.10 Analysis by Preferred Term 
  • 6.11 Analysis by Preferred Term II 
  • 6.12 Analysis by Preferred Term III 
  • 6.13 Analysis by Age Range 
  • 6.14 Analysis by Sex 
  • 6.15 Analysis by Country 
  • 6.16 Analysis by Time to Onset 
  • 6.17 Analysis by Treatment Duration 
  • 6.18 Analysis by AE Duration 
  • 6.19 Analysis by concomitant medications 
  • 6.20 Analysis by concomitant medications II 
  • 6.21 Conclusion
  • 6.22 Mini exam 

7. Data Mining Examples 

  • 7.1 What is Data Mining? 
  • 7.2 Principles of Safety Data Mining 
  • 7.3 Principles for Safety Data Mining II 
  • 7.4 Data Mining Challenge 
  • 7.5 Recommended approach – Large Companies 
  • 7.6 Mini exam

8. Data Mining Methods 

  • 8.1 Data Mining Methods 
  • 8.2 Information Component (IC) 
  • 8.3 Bayesian Confidence Propagation Neural Network (BCPNN) 
  • 8.4 PSUR Data 
  • 8.5 IC Scores - PSUR 
  • 8.6 Multi-item Gamma Poisson Shrinker (MGPS) 
  • 8.7 Proportional Reporting Ratio (PRR) 
  • 8.8 PRR Example 
  • 8.9 Final Conclusion!
  • 8.10 Mini exam


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