This course cover basic concepts as well as the history, need, aims and scope of pharmacovigilance. It serves as an introduction for anyone with an interest in pharmacovigilance.
| Module 1 | 1. Introduction to pharmacovigilance | |
|---|---|---|
| Unit 1 | Introduction to Pharmacoviginalce | |
| Unit 2 | The history of PV | |
| Unit 3 | The Burden Of Adrs And The Need For Pv | |
| Unit 4 | Aims Of Pv | |
| Unit 5 | The Scope Of Pv Part 1,2,3 | |
| Module 2 | 2. Signal detection and causality assessment | |
| Unit 1 | What Is A Signal, When Does Signal Detection Start & Why Do We Need Signal Detection | |
| Unit 2 | Where Can We Find Signals, What Triggers A Signal, How Do We Assess A Signal | |
| Module 3 | 3. Statistical reasoning and algorithms in pharmacovigilance | |
| Unit 1 | Statistical Reasoning And Algorithms In Pv, Dis-proportionality, Relative Reporting Ratio (Rr) | |
| Unit 2 | Random Variability, Decision Rules,Aspects Of Strength Of Evidence, A Cautionary Note | |
| Module 4 | Medical Dictionary for Drug Regulatory Activities (MedDRA) | |
| Unit 1 | Medical Dictionary for Drug Regulatory Activities (MedDRA) | |
| Module 5 | Individual Case Safety Reports (Icsrs) | |
| Unit 1 | Individual Case Safety Reports (Icsrs) | |
| Module 6 | Periodic safety update report (PSUR) | |
| Unit 1 | Periodic safety update report (PSUR) | |
| Unit 2 | Dsur Vs Psur in Pharmacovigilance | |
| Module 7 | Online Examination | |
| Unit 1 | Quiz |
