Pharmacovigilance (PV) Training

Our safety team excels in providing a variety of pharmacovigilance (PV) training courses to suit the needs of our clients. The courses are most updated, customized and integrated. We can create your own study packages based on your learning objectives. Sample courses are listed as follows

PV-INTRO

  • Organization of Global Safety Dept
  • Clinical Trials
  • Pharmacovigilance Theory & Definitions
  • The Roles and Interactions of Companies, Governments, and others 

PV-ICSR

  • AE/SAE Handling

PV-Coding

  • Coding
  • MedDRA point to consider 

PV-Medical Review

  • Seriousness Assessment
  • Expectedness Assessment 
  • Causality Assessment
  • Drugs Safety in Special Groups
  • Clinical Trial Safety Monitoring
  • Post-Marketing Safety Monitoring 

PV-Safety Data Analysis

  • Mathematics
  • Big Data Analysis
  • Data Mining
  • Signal Detection

PV-Risk Management

  • Risk and Risk Management and Assessment
  • Risk Specification
  • Risk Analysis
  • Risk Minimization

PV-Aggregate Report

  • Safety Report
  • DSUR
  • PSUR
  • PEBRA
  • Other Safety Aggregate Reports