Integrated pharmacovigilance refers to the comprehensive and coordinated approach of monitoring, assessing, and managing the safety of pharmaceutical products throughout their lifecycle. It involves the integration of various functions, processes, and stakeholders to ensure the continuous surveillance of the benefits and risks associated with medical products, such as drugs and medical devices. The goal of integrated pharmacovigilance is to enhance patient safety, improve decision-making, and facilitate efficient regulatory oversight.

1. Welcome
INTEGRATED PHARMACOVIGILANCE
GOKUL.N.M.S
M.Sc., BIOECHNOLOGY
173/082023
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2. CONTENTS
 PHARMACOVIGILANCE
 METHODS OF
PHARMACOVIGILANCE
 WHY INTEGRATED NEEDED?
 HOW INTEGRATED WORKS?
 BENEFITS OF INTEGRATION
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3. PHARMACOVIGILANCE
DEFINITION:
• A Field which dedicated to Assessment, Collection, Detection, Reporting,
Identification, Monitoring and Prevention of Adverse Event or Reaction of
drugs called PHARMACOVIGILANCE.
• A unpleasant reaction or harmful even happening after taking the drugs or
medicinal products is known as Adverse event or reaction (ADR or ADE).
• 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.
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4. OBJECTIVES:
1. Early detection of unknown adverse reaction and reactions of drugs.
2. Assessing the frequency of known adverse reaction or event.
3. Identification of risk factors & possible mechanism underlying adverse drug
reaction or event.
4. Dissemination of information needed to improve drug prescribing &
regulation
5. Estimation of quantitative aspects of benefits and risk analysis.
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5. ULTIMATE GOALS:
i) The rational and safe usage of medicinal drugs.
ii) The assessment and communication of risk and benefits of
drugs in the market.
iii) The education and informing about the drugs to patients and
customers.
iv) To ensure public health and safety.
v) To promote clinical trials important and patient health &
safety.
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6. METHODS OF PHARMACOVIGILANCE
• Passive Surveillance
i) spontaneous Reports
ii) Case Series
• Stimulated Reporting
• Active Surveillance
i) Sentinel Sites
ii) Drug event monitoring
iii) Registries
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7. METHODS OF PHARMACOVIGILANCE
• Comparative Observational Studies
i) Cross-sectional study(survey)
ii) Case-control study
iii) Cohort study
• Targeted Clinical Investigations
• Descriptive Studies
i)Natural history of disease
ii)Drug utilization study
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8. WHY INTEGRATED NEEDED?
• The pharmaceutical market is highly regulated & any misstep can lead to product
recall that have a multi-prolonged impact.
• So, its important to build systems that allows one track and monitor potential
challenges
• Drug safety is a major concern in life-science & health care industry that requires
constant attention and monitoring.
• So with increasing number of complex safety cases & associated reports being
submitted to regulators around the world, it has become major important for drug
companies to manage & submit safety data efficiently.
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9. WHY INTEGRATED NEEDED?
• So, the pharmacovigilance departments in the life-
science and health care industry are now under
pressure to do more than ever with less resources.
• An Integrated approach to managing
pharmacovigilance is the key to obtaining the
efficiency and ensuring compliance.
• The dealing of huge number of safety data reports
with less number of resource information by
modern system or method is called as
INTEGRATED PHARMACOVIGILANCE.
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10. HOW INTEGRATED WORKS?
• Using the modern AI/ML and Automation techniques
will give us new age safety systems to deal safety data
problems.
• Key features of new age safety systems
i) Leveraging AI/ML for automation
and insights.
ii) Modern, Secure & Configurable
Saas.
iii) Reduced costs and improved
compliance through automation.
• Industry leaders are exploring integrated approaches
to safety case processing and submissions, signal and
risk management , literature monitoring and
regulatory intelligence for safety.
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11. HOW INTEGRATED WORKS?
• There is an DF Safety 4.o cloud platform which is an intuitive, unified, cloud
–bases safety platform for safety case management through report
submission.
• It is fully integrated platform tools and functionally, offering comprehensive
safety management via a clear, intuitive, and user friendly interface.
• It automates multiple manual processes like case intake, triage, narrative
generation with integrated dictionaries, seriousness prediction & causality
assessment.
• It has integrated PV literature monitoring and reporting function.
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12. BENEFITS OF INTEGRATION
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14. REFFERENCES
• https://www.apcerls.com/insights/infographics/be
nefits-of-integrated-pharmacovigilance/
• https://datafoundry.ai/2022/01/an-integrated-
approach-to-pharmacovigilance/
• https://www.slideshare.net/drsukant/pharmacovigilan
ce-54368523
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15. Thank You!
www.clinosol.com
(India | Canada)
9121151622/623/624
info@clinosol.com
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