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 | Pharmacovigilance Aggregate report |
| Unit 1 | PV-1.Development Safety Update Report (Dsur)&Benefit-Risk Evaluation Reports (Pbrers) |
| Unit 2 | Aggregate report writing in PV- 2. Dsur And Pbrer(Section1 To Section-5) |
| Unit 3 | Aggregate report writing in PV- 3 Dsur And Pbrer(Section 6 & Section-7) |
| Unit 4 | Aggregate report writing in PV- 4. Dsur And Pbrer( Section 8 To Section-15) |
| Unit 5 | Aggregate report writing in PV- 5. Dsur And Pbrer( Section 16 To 18) |
| Unit 6 | Aggregate report writing in PV-6. Dsur And Pbrer (Section -19) |
| Unit 7 | Aggregate report writing in PV-7. Practice Dsur And Pbrer |
| Unit 8 | Aggregate report writing in PV-8. Periodic Adverse Drug Experience Report (Pader) |
| Unit 9 | Aggregate report writing in PV-9. Risk Management Plan(Rmp) |
| Module 7 | Periodic safety update report (PSUR) |
| Unit 1 | Periodic safety update report (PSUR) |
| Unit 2 | Dsur Vs Psur in Pharmacovigilance |
| Module 8 | Oracle Argus Safety – Theoretical Software Training |
| Unit 1 | Session 2 - Process Of Login, User Interface And Navigation - Oracle Argus Safety |
| Unit 2 | Session 3 - Active Cases And Case Actions In Argus Safety |
| Unit 3 | Session 3.1 - Worklist In Argus Safety |
| Unit 4 | Session 3.2 - Reports Tab In Argus Safety |
| Unit 5 | Session 3.3 - Dashboards And Utilities In Argus Safety |
| Unit 6 | Session 4 - Tabs And Fields Of Case Form & Management Of Cases In Argus Safety |
| Unit 7 | Session 5 - Drug And Event Coding In Argus Safety |
| Unit 8 | Session 6 - Case Management Workflow In Argus Safety |
| Unit 9 | Session 6.1 - Case Processing Of Spontaneous Case In Argus Safety |
| Unit 10 | Session 7 - Overview Of Advanced Conditions And Building Complex Queries In Argus Safety |
| Unit 11 | Session 8 - Aggregate Reporting - Generating Psur In Argus Safety |
| Unit 12 | Session 8.1 - Aggregate Reporting - Clinical Trial Periodic Reports (Ctpr) In Argus Safety |
| Unit 13 | Session 8.2 - Aggregate Reporting - Ind And Nda In Argus Safety |
| Unit 14 | Session 8.3 - Aggregate Reporting - Case Data Analysis, Case Listing, Cioms Ii Line Listing |
| Module 9 | Online Examination |
| Unit 1 | Quiz |
