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Electronic Pharmacovigilance Systems : Drug Safety Surveillance

Electronic Pharmacovigilance Systems : Drug Safety Surveillance. Z. Mastaneh, Ph.D. Presentation Overview. Pharmaceutical Industry & Pharmacovigilance (PV) Pharmacovigilance (PV) & Information Technologies. Pharmaceutical Industry & Pharmacovigilance (PV). Thalidomide & Phocomelia.

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Electronic Pharmacovigilance Systems : Drug Safety Surveillance

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  1. Electronic PharmacovigilanceSystems: Drug Safety Surveillance Z. Mastaneh, Ph.D

  2. Presentation Overview • Pharmaceutical Industry & Pharmacovigilance (PV) • Pharmacovigilance (PV) & Information Technologies

  3. Pharmaceutical Industry & Pharmacovigilance (PV)

  4. Thalidomide & Phocomelia

  5. Drug Safety Assessment • Two main phases: • Pre – marketing • Post - marketing Limited Size Narrow Population (age and sex specific) Narrow Indication (only specific disease) Short Duration

  6. Drug Safety Assessment Pharmaceutical Industry & Pharmacovigilance (PV)

  7. Pharmacovigilance (PV) Pharmakon ----- in Greece ------ drug Vigilare ---------- in Latin ------- to keep watch Activities relating to detection, assessment, understanding and prevention of Adverse Drug Reactions (ADRs). (WHO)

  8. Pharmacovigilance (PV) & Information Technology (IT)

  9. International ADR Database Spontaneous Case Reports Case Series Reports National ADR Database Electronic Health Records Data Data from Patient Registries • Case Reviews • Data Mining • … Cohort Studies Results

  10. Prerequisites of National ADR Database • A common reporting form (Electronic form with specific data elements) • Agreed guidelines for data formulating and entering • Common terminologies and classifications • Compatible systems for transmitting, storing, retrieving and disseminating information

  11. Benefits of IT for PV • Safer use of medicines • Quick and timely decision making and taking necessary actions • Reduce costs of ADRs • Observe ethical considerations • Insuring public confidence

  12. Pharmaceutical industry ranking in top 10 profitable industries Furtune Journal, 2010

  13. Interesting Conclusion

  14. غروب زیبا ی ساحل خلیج فارس

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