pharmacovigilance - the veritas career solutions pvt ltd
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Pharmacovigilance - The Veritas Career Solutions Pvt Ltd
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What is Pharmacovigilance?
Pharmacovigilance (abbreviated PV or PhV), also known as Drug Safety, is the pharmacological science relating to the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products. The etymological roots for the word “pharmacovigilance” are: pharmakon (Greek for drug) and vigilare (Latin for to keep watch).
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Course Contents:1. Introduction to Pharmacovigilance
2. Global Pharmacovigilance System and the current trends
3. Sources and Documentation of Individual Case Safety Reports (ICSRs)
4. Case processing and Reporting
5. Medical dictionary (MedDRA) and Medi
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6. Special cases in Pharmacovigilance
7. Medical Information System
8. Safety monitoring in Clinical Trials
9. Signal detection
10. Periodic Safety Update Reports (PSURs) and suspected unexpected serious adverse reactions Medication errors (SUSARs)
11. Risk –benefit assessment and management in Pharmacovigilance
12. Standard operating procedures in Pharmacovigilance
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13. Compliance monitoring and Pharmacovigilance inspections
14. Global regulatory requirements and guidelines in Pharmacovigilance
15. Pharmacovigilance communications
16. Pharmacoepidemiology
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