Foundations of Global Pharmacovigilance · Section 1.12
~3 min read · The Drug Safety Coach — Global PV Career Course
Key points
Full text
Pharmacovigilance has evolved from a reactive response to the thalidomide catastrophe into a proactive, data-driven, globally integrated discipline — grounded in the same research ethics that emerged from Nuremberg, Helsinki, and Belmont, run through a workflow that is essentially identical in every country on earth, and reshaped in just the last eighteen months by three of the biggest regulatory changes the field has seen: ICH E6(R3), EU Regulation 2025/1466, and the CIOMS WG XIV AI framework.
But its core purpose has not changed in six decades: protect the patient. Detect harm. Assess it honestly. Understand who is at risk and why. Prevent further harm through clear, timely communication and decisive regulatory action. Re-evaluate the benefit-risk balance continuously throughout the product’s lifetime.
From here, the course moves into the global regulatory framework in depth — the regulators, the standards, and the systems that turn these principles into daily practice worldwide.
Quick check
Test yourself before moving on — no pressure, just click an answer.
1. Across this entire module, which single test appears in three different forms — the four SAE criteria, the four valid ICSR elements, and the three SUSAR criteria?