Pharmacovigillance and Drug Safety

  • Importance of Pharmacovigillance: Safety Monitoring of Medicinal Products
  • Pharmacovigillance in Drug Regulation
  • Monitoring Safety in Clinical Trials and Drug Development
  • Role of Pharmacovigillance in drug development
  • Post-marketing safety monitoring
  • Adverse events reporting: Individual Case Safety Report (ICSR), Expedited reporting, Spontaneous & Aggregate reporting, Coding of adverse events etc.
  • Risk management: Causality assessment, Risk management plans, Risk to benefit profile of drugs
  • Pharmacoepidemiology, Pharmacogenetics and pharmacogenomics
  • REMS/RMP design, Clinical Trials Registries

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