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MEESA KALYANI
B.Pharmacy
205/102023
CONTENTS
➢ PHARMACOVIGILANCE
➢ AIMS AND SCOPE
➢ METHODS OF PHARMACOVIGILANCE
➢ WHY INTEGRATED NEEDED?
➢ HOW INTEGRATED WORKS?
➢ BENEFITS OF INTEGRATION
2
PHARMACOVIGILANCE
DEFINITATION :
• Pharmacovigilance is the science and activity relating to the detection, assessment,
understanding and prevention of adverse effects or any other medicine/related problem.
• All medicines and vaccines undergo rigorous testing for safety and efficacy through
clinical trials before they are authorised for use.
• Thalidomide tragedy happened in early 19th century of Germany triggered the needed of
Pharmacovigilance, because of off-label usage of drug by pregnant women resulted in
defective limbs in born babies.
3
AIMS AND SCOPE
• To improve patient care & safety in relation to medicines & all medical & para-
medical Interventions.
• To improve public health & safety in relation to the use of medicines.
• To contribute to the assessment of benefit, harm, effectiveness and risk of
medicines.
• To promote understanding, clinical training & effective communication to health
professionals & the public.
5
6
7
8
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10
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Integrated pharmacovigilance

  • 2. CONTENTS ➢ PHARMACOVIGILANCE ➢ AIMS AND SCOPE ➢ METHODS OF PHARMACOVIGILANCE ➢ WHY INTEGRATED NEEDED? ➢ HOW INTEGRATED WORKS? ➢ BENEFITS OF INTEGRATION 2
  • 3. PHARMACOVIGILANCE DEFINITATION : • Pharmacovigilance is the science and activity relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine/related problem. • All medicines and vaccines undergo rigorous testing for safety and efficacy through clinical trials before they are authorised for use. • Thalidomide tragedy happened in early 19th century of Germany triggered the needed of Pharmacovigilance, because of off-label usage of drug by pregnant women resulted in defective limbs in born babies. 3
  • 4. AIMS AND SCOPE • To improve patient care & safety in relation to medicines & all medical & para- medical Interventions. • To improve public health & safety in relation to the use of medicines. • To contribute to the assessment of benefit, harm, effectiveness and risk of medicines. • To promote understanding, clinical training & effective communication to health professionals & the public.
  • 5. 5
  • 6. 6
  • 7. 7
  • 8. 8
  • 9. 9
  • 10. 10
  • 11.
  • 12. 14