B.Pharmacy 8th Semester Pharmacovigilance Notes & Important Question Answer
B.Pharma VIIIth Semester Pharmacovigilance Important Topics With All The Important Question And Answer Are Publish Here Download the Pdf and Give boost To Your Preparation. Stay Connected with us for your future examination all the important content will publish here . Your Full Pharmacy Syllabus will Be published here.
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B.Pharmacy 8th Semester Pharmacovigilance Notes |
Pharmacovigilance - Unit 1
Introduction to Pharmacovigilance
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History and development of Pharmacovigilance
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Importance of safety monitoring of Medicine
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WHO international drug monitoring programme
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Pharmacovigilance Program of India (PvPI)
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Relevant terminologies of PV
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Adverse Drug Reactions: Classification – Detection and reporting – Causality assessment – Severity and seriousness assessment – Predictability and preventability assessment – Management of adverse drug reactions
Pharmacovigilance - Unit 2
Basic terminologies used in pharmacovigilance
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Types of adverse drug reactions
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Detection and reporting methods of ADRs
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Spontaneous reporting systems
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Intensive Monitoring systems
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Targeted Clinical Investigations
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Active Surveillance
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Comparative Observational Studies: Cohort, Case-Control, Cross-sectional
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Case reports and case series
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National and international PV centers
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Resources for information on drug safety
Pharmacovigilance - Unit 3
Vaccine safety surveillance
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Medication error: Definition, classification, causes
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Risk factors, reporting and prevention of medication error
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Adverse Event Following Immunization (AEFI)
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Role of hospital and community pharmacist in medication safety
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Communication in pharmacovigilance
Pharmacovigilance - Unit 4
Basic concepts of risk management
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Risk assessment, risk minimization, risk communication, risk evaluation
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International guidelines for pharmacovigilance: ICH E2E pharmacovigilance planning
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Pharmacovigilance methods: Passive surveillance, active surveillance, cohort event monitoring, Targeted spontaneous reporting
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Safety data sources: pre-clinical, clinical, post-marketing data
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WHO-UMC data management and safety reporting
Pharmacovigilance - Unit 5
Pharmacogenomics of adverse drug reactions
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ICH guidelines for pharmacovigilance
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Good pharmacovigilance practices (GVP)
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Pharmacoepidemiology
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Vaccine vigilance
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Safety reporting requirements for biologics
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Special population: Pediatrics, geriatrics, pregnancy and lactation
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Global perspective of pharmacovigilance
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