Introduction to Good Pharmacovigilance Practice (GVP)

This Introduction to Good Pharmacovigilance Practice (GVP) is a concise, beginner-friendly foundation course covering what pharmacovigilance is, why drug safety matters and how the global regulatory landscape works. Across eight focused modules learners build core vocabulary (AE, ADR, SAE, SUSAR, signal, risk-benefit), walk the medicine lifecycle from pre-clinical to post-marketing, meet Individual Case Safety Reports, signal detection, risk management, and learn how to develop a Pharmacovigilance Plan aligned to ICH E2E, including FDA pharmacoepidemiologic assessment guidance and the four-section PV plan structure. The course closes with technology, AI and careers in PV — pointing learners toward Whitehall's advanced PV programmes for operational mastery.

Designed for PV new hires, nurses transitioning into pharma, pharmacists, life-science graduates, clinical research and regulatory staff, and corporate learners needing an annual GVP refresher. On completion you will define pharmacovigilance confidently, recognise EMA GVP / MHRA / FDA / ICH frameworks and EudraVigilance, apply core PV terminology correctly, place activities into the medicine lifecycle, describe ICSR fundamentals, walk the signal management lifecycle and risk minimisation toolkit, and plan progression into Whitehall's advanced PV courses. Aligned to EMA GVP Modules, MHRA expectations, FDA PV awareness, ICH E2 family and CIOMS conventions.