Pharmacovigilance and Drug Safety

Pharmacovigilance activities related to collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products and the safety surveillance and risk management. PV are to enhance patient care and patient safety in relation to the use of medicines; and to support public health programmers by providing reliable, balanced information for the effective assessment of the risk-benefit profile of medicines. Pharmacovigilance plays a critical role in minimizing the risk of any harm that may come to patients by safety surveillance, risk management and identifying the hazards associated with pharmaceutical products.

  • Regulatory requirements for product safety
  • Perform signaling analysis
  • Risk assessment and management functions
  • Criteria for QPPV role
  • Role of therapeutic goods regulation
  • Signal detection
  • Causality assessment

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