An Introduction for Pharmacovigilance Managers

Technical test

Welcome and introduction

Introduction to drug safety

• What is drug safety?
• Information sources
• How is safety information generated?
• Elements of the pharmacovigilance system
• EU QPPV and local QPPVs using the German "Stufenplanbeauftragte*r" as an example
• Important definitions and abbreviations

Regulatory framework

• Overview and classification of relevant regulations
• International and European guidelines and regulations
• National requirements in the EU
• Good pharmacovigilance practices (GVP)
• Pharmacovigilance network: Federal and state authorities, EMA, PRAC, etc.

Quiz: What have we learned?

Collecting, recording, and reporting drug risks

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

Workshop: Single-case causality assessment

Evaluation and signal management

• Cumulative evaluation and signal management
• Causality vs benefit-risk assessment
• Benefit-risk assessment: CTD, PSUR/PBRER, PASS, PAES
• Post-authorisation safety studies (PASS)
• Benefit-risk assessment methods
• Referrals

Interfaces with other departments

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

Summary of Day 1

Risk management in PV

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

Workshop: Risk minimisation measures and risk communication

The pharmacovigilance system master file (PSMF)

Periodic and development safety update report (PSUR/DSUR)

• Format, content, and submission
• Patient exposure and reporting rates
• Process and project management

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: Drug safety in the life cycle of a drug

Summary and discussion