Introduction to Pharmacovigilance
- Definition, history, and importance of pharmacovigilance
- Key concepts and terminology
- Stakeholders and their roles in pharmacovigilance
Adverse Drug Reactions (ADRs)
- Types and classification of ADRs (Type A, B, C, D)
- Serious vs. non-serious ADRs
- Expected vs. unexpected ADRs
Causality Assessment
- WHO and Naranjo algorithm
- CIOMS/RUCAM scale for drug-induced hepatotoxicity
- Practical case analysis
Good Pharmacovigilance Practices (GVP)
- Overview of GVP modules
- Pharmacovigilance processes and systems
- Roles of marketing authorization holders and regulatory agencies
Signal Detection and Risk Management
- Signal detection methodologies (PRR and other statistical tools)
- Risk minimization and communication strategies
- Post-authorization safety studies (PASS)
Benefit/Risk Evaluation
- Methods to assess benefit-risk balance
- Case studies and practical examples
Pharmacovigilance Legislation and Guidelines
- EU and international perspectives
- Legal obligations for reporting ADRs