An Introduction for Pharmacovigilance Managers

Technical warm-up

Start of course: Welcome and introduction

Introduction to pharmacovigilance

• What is pharmacovigilance?
• Information sources
• How is safety information generated?
• The pharmacovigilance system
• EU QPPV and local QPPVs
• Important definitions and abbreviations

Regulatory framework

• Pharmacovigilance network: EMA, PRAC, and national authorities
• What does the law say?
• International and European guidelines
• Good pharmacovigilance practices (GVP)
• National requirements in Europe

Quiz: What have we learned?

Collecting, recording, and reporting

• Regulatory framework and definitions
• Documentation and reporting requirements
• Individual Case Safety Reports (ICSRs)
• EudraVigilance and EVDAS
• Single-case causality assessment

Workshop: Single-case causality assessment

Signal management and safety evaluation

• Signal management and cumulative evaluation of safety data
• Causality vs benefit-risk assessment
• Regulatory toolbox
• Post-authorisation safety studies (PASS)
• Benefit-risk assessment - the basics
• Referral procedures at EU level

Interfaces with other departments

• Overview
• Departments including clinical research, regulatory affairs, quality management, sales and marketing, management level etc.
• Conflict points and solutions

Start of day 2: Summary of day 1

Risk management in PV

• The risk management plan (RMP)
• Identified risks, potential risks, and missing information
• Routine and additional risk minimisation measures (RMMs)
• RMP in the life cycle

Workshop: Risk minimisation measures and risk communication

The pharmacovigilance system master file (PSMF)

Development/periodic safety update reports (DSUR/PSUR)

• Format, content, and submission requirements
• Patient exposure and reporting rates
• PSUR Single Assessment

Quality management in PV

• Basics of QA systems in PV
• SOPs, KPIs, CAPAs, and more
• Who needs to be trained?
• Documentation and archiving

Pharmacovigilance audits and inspections

• Who inspects, when and what?
• Exercise: The risk-based audit strategy
• Inspection readiness

Workshop: Safety in the life cycle of a medicinal product

Summary and discussion