Good Pharmacovigilance Practice

Good Pharmacovigilance Practices (GVP) begins with the acquisition of complete data from spontaneous adverse event reports. GVP characterizes the adverse event details, baseline patient characteristics, therapy details, diagnosis of the events and clinical course of the event. The role of Good Pharmacovigilance Practice and Pharmacoepidemology in Risk Management is mainly to  increase the probability of beneficial effects of a drug in a population than the probability of adverse effects and to maintain the Good Reporting Practices by avoiding the major problems in risk management. Also it is important to concentrate on Signal investigation by gathering the information on new or unknown drug effects that is potentially caused by a medicine and that finally should lead to ensuring safety. The pharmacovigilance and clinical trials services providing companies should have the Pharmacovigilance certification .

  • Role of pharmacovigilance and pharmacoepidemiology in risk management
  • Good reporting practices
  • Signal investigation via observational studies
  • Interpreting safety signals
  • Randomized clinical trials
  • Ethical and social aspects of drug use

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