Fundamentals
of
Pharmacovigilance

Duration: 4 weeks (10 hours)
Can be taken individually: Yes

Learning Objectives

By the end of this course, learners will be able to:

• define pharmacovigilance and its role in patient safety;

• explain the lifecycle approach to drug safety;

• understand the role of regulators, MAHs, HCPs, and patients;

• recognize major global PV frameworks.

Weekly Topics

Week 1: Introduction to Pharmacovigilance

• Definition and objectives of PV

• History of drug safety

• Patient safety as the foundation of PV

• Global PV ecosystem

Week 2: Regulatory Framework

• Health Canada, FDA, EMA, WHO

• ICH guidelines overview

• MAH obligations

• Post-market surveillance

Week 3: Safety Data Sources

• Spontaneous reports

• Literature

• Clinical trials

• Registries

• Social media and digital sources

Week 4: PV Systems and Governance

• Safety departments

• Local vs global PV roles

• SOPs, quality systems, audits and inspections

Assessment

Short quiz + assignment: e.g. Identify safety data sources for a marketed product.