Curriculum
- 4 Sections
- 55 Lessons
- 10 Weeks
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- Module 1 – Fundamentals of Global Pharmacovigilance8
- 1.1Introduction to Drug Safety and PV
- 1.2Key PV Terminology (Side Effect, Drug Safety and Risk Terms)
- 1.3International Regulatory Requirements and Guidelines Overview
- 1.4Pharmacovigilance Quiz
- 1.5Regional Regulatory Requirements (FDA, EMA, Japan, China)
- 1.6Post-marketing Surveillance and Safety Management
- 1.7GVP – Pharmacovigilance Abbreviations
- 1.8Advanced Review of Adverse Event Reporting
- Module 2 – Advanced Review of Pharmacovigilance19
- 2.1Advanced Practice of Pharmacovigilance
- 2.2Pharmacovigilance Quiz
- 2.3Additional Encompassing and Confusing Terms in Pharmacovigilance
- 2.4MedDRA (Hierarchy, Searching, Terms, Exporting, Assessing, Important Medical Events)
- 2.5Pharmacovigilance Quiz
- 2.6Need for Pharmacovigilance
- 2.7The History of Pharmacovigilance
- 2.8Roles in Pharmacovigilance
- 2.9Pharmacovigilance Quiz
- 2.10Key Stakeholders in Pharmacovigilance
- 2.11Pharmacovigilance Quiz
- 2.12Post-marketing AE Processing and Reporting (ICSR, Case Processing, Narrative Writing & International Aggregate Reporting)
- 2.13Pharmacovigilance Quiz
- 2.14Signal Management (Detection, Validation, Prioritization and Action)
- 2.15Pharmacovigilance Quiz
- 2.16Risk Assessment, Plan and Management
- 2.17Pharmacovigilance Quiz
- 2.18Vaccine Surveillance – COVID-19 Updated (AEFI, Vaccinology, AESI, AVSS, Communication and Case Studies)
- 2.19Post-authorization/ Post-marketing Regulations in Pharmacovigilance
- Module 3 – Argus Safety Database Certification7
- 3.1Argus Safety Database Certification Part 1
- 3.2Argus Safety Database Certification Part 2
- 3.3Argus Safety Database Certification Part 3
- 3.4Argus Safety Database Certification Part 4
- 3.5Argus Safety Database Certification Part 5
- 3.6Argus Safety Database Certification Part 6
- 3.7Oracle Argus Safety User Guide
- Module 4 – Resources21
- 4.1International Pharmacovigilance Initiatives and Guidelines – EMA
- 4.2DIA Safety and Pharmacovigilance Competencies
- 4.3WHO-ISoP Pharmacovigilance Resources
- 4.4E2E ‒ Pharmacovigilance Planning
- 4.5GVP XVI Addendum ‒ Educational Materials
- 4.6GVP Module I‒IV PV Systems, PSMF, Inspections & Audits
- 4.7GVP I – Pharmacovigilance Systems
- 4.8GVP VIII – Post-authorisation Safety Studies
- 4.9GVP III – Pharmacovigilance Inspections
- 4.10GVP IX – Methodological Aspects
- 4.11GVP V – Risk Management Systems
- 4.12GVP IX – Signal Management
- 4.13GVP VIII Addendum – Requirements, Recommendations
- 4.14GVP XV – Safety Communication
- 4.15GVP XVI – Risk Minimization Measures
- 4.16GVP II – Pharmacovigilance System Master File
- 4.17GVP VI – Duplicate Management
- 4.18GVP IV – Pharmacovigilance Audits
- 4.19GVP X – Additional Monitoring
- 4.20GVP VII – Periodic Safety Update Report
- 4.21GVP VI – Collection, Management and Submission of Reports