Pharmacovigilance Training Online
Choose from 4 GPvP Online Courses

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.
3 hrs
3 points
£79.00
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.
1. Learning Objectives for this Module |
2. Background to Signal Detection |
Need for Signal Detection |
Increased Withdrawals (1998-2001) |
3. Reason for Change |
Rezulin Withdrawal |
Baycol Withdrawal |
The Cost of Failure |
4. Legalities |
FDA Risk Management Components |
FDA Amendment Act (FDAAA) |
EMA Signalling Requirement |
MHRA & Signal Detection |
GVP Module IX |
5. Signal Detection Objectives & Key Components |
AE Incidence Rate |
Numerator (AEs) |
Denominator (Patient Exposure) |
Rates |
Premise |
CIOMS VIII reference to the “Prepared Mind” |
Signal detection hierarchy |
6. Signalling Analyses |
Approach to Signal Detection – Small Companies |
Approach to Signal Detection – Large Companies |
Data extraction and visualization |
Data flow |
PSUR prior to analysis |
Sector map by SOC |
Sector Map by PT |
Analysis by Preferred Term |
Analysis by Age Range |
Analysis by Sex |
Analysis by Country |
Analysis by concomitant medications |
7. Data Mining Examples |
What is Data Mining? |
Principles of Safety Data Mining |
Recommended approach – Large Companies |
8. Data Mining Methods |
Data Mining Methods |
Information Component (IC) |
Bayesian Confidence Propagation Neural Network (BCPNN) |
PSUR Data |
IC Scores - PSUR |
Multi-item Gamma Poisson Shrinker (MGPS) |
Proportional Reporting Ratio (PRR) |
PRR Example |