Pharmacovigilance Training Course

The Syllabus covers

1: Introduction to Pharmacovigilance
⦁ Definition and scope of pharmacovigilance (PV)
⦁ History and evolution of PV
⦁ Objectives and importance in healthcare and drug safety
⦁ Key stakeholders: regulatory authorities, MAHs, CROs, HCPs

2: Regulatory Framework and Guidelines
⦁ International and national PV regulations
⦁ Key regulatory bodies:
⦁ FDA (USA)
⦁ EMA (Europe)
⦁ CDSCO (India)
⦁ MHRA (UK)
⦁ PMDA (Japan)
⦁ ICH Guidelines (E2E, E2D)
⦁ GVP (Good Pharmacovigilance Practices)

3: Adverse Drug Reactions (ADRs)
⦁ Definition and classification (Type A/B)
⦁ Serious vs. non-serious ADRs
⦁ Expected vs. unexpected ADRs
⦁ Tools for assessing causality (WHO-UMC, Naranjo Algorithm)

4: Individual Case Safety Reports (ICSRs)
⦁ Components and structure of an ICSR
⦁ Data collection and validation
⦁ Narrative writing and case quality
⦁ MedDRA and WHO-DD coding
⦁ Timelines for expedited reporting

5: Signal Detection and Risk Management
⦁ Signal identification, validation, and prioritization
⦁ Quantitative and qualitative methods for signal detection
⦁ Risk Management Plan (RMP) and Risk Evaluation & Mitigation Strategies (REMS)
⦁ Pharmacovigilance Planning (PVP)

6: Aggregate Reporting
⦁ Periodic Safety Update Reports (PSUR)
⦁ Periodic Benefit-Risk Evaluation Reports (PBRER)
⦁ Development Safety Update Reports (DSUR)
⦁ Literature screening and review

7: Case Processing and Workflow
⦁ Workflow of case receipt to submission
⦁ Data entry, triage, duplicate checks
⦁ Medical review and quality check (QC)
⦁ Electronic submissions (E2B format)

8: Pharmacovigilance Databases and Tools
⦁ Overview of global safety databases: Argus, ARISg, VigiBase, etc.
⦁ E2B (R3) data standards
⦁ Introduction to PV software (manual & electronic data entry)
Coding dictionaries: MedDRA, WHO-DD

9: Clinical Trial Safety
⦁ Safety reporting in clinical development (pre-marketing)
⦁ SAE reporting timelines and reconciliation
⦁ Unblinding in trials for safety evaluation
⦁ Sponsor-investigator communications

10: Regulatory Submissions and Inspections
⦁ EudraVigilance and FDA FAERS
⦁ EMA’s EVMPD, IDMP
⦁ Audit readiness and compliance
⦁ PV inspection scope and documentation

11: Career Pathways and Professional Ethics
⦁ Roles in PV: Case processor, Medical reviewer, QPPV
⦁ Interview preparation and resume tips
⦁ Career opportunities in pharma, CROs, and KPOs
⦁ Ethics and confidentiality in pharmacovigilance

12: Certification & Mock Assessment
⦁ Preparation for industry-standard certifications (e.g., DIA, IPHARM, or company-specific)
⦁ Mock tests and case study reviews
⦁ Final assessment and feedback
⦁ Course completion and certification