About the Course
Pharmacovigilance (PV) is the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems throughout a medicine’s life cycle. It ensures patient safety by monitoring marketed drugs for side effects not detected during clinical trials, involving data collection, signal detection, and risk management
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Introduction
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Fundamentals
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Problems Due to Inadequate PV System Part 1 -
Active Ingredients Withdrawn Part 2
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Pharmacovigilance Definition Part 3
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Pharmacovigilance Aim and Responsbilites Part 4
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Lifecycle of Drug and Pharmacovigilance Part 5
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Need of Pharmacovigilance Even After Clinical Trials. Part 6
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Do Pharmacovigilance Needed in Every Country Part 7
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Term Definitions Part 8
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Term Definitions Part 9
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Partners in Pharmacovigilance Part 10
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Drug Regulatory Authorities Part 11
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Pharmacovigilance Help and Rational Part 12
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What to Report Part 13
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History of Pharmacovigilance Evolution Part 14
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AE Sources and Principles
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ICSR Processing
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Data Handling
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Narrative Writing
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Drug Labelling
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Re-Assessment
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Signal Management
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PV Coding