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A Practical Guide for Pharmacovigilance Practice in Africa

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About Course

This course provides a comprehensive, Africa-centred foundation in pharmacovigilance, the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problem. It is designed for practising health professionals, pharmacy graduates, regulatory affairs officers, public health practitioners, and advanced students across all African regions.

While global frameworks and international standards are taught rigorously, every module is anchored in African epidemiological realities, regulatory architectures, resource environments, and disease priorities. The course bridges the gap between international best practice and the specific challenges of implementing pharmacovigilance in low- and middle-income settings.

What Will You Learn?

  • You will define pharmacovigilance, explain its scope, and articulate its importance within the African health systems context.
  • You will be able navigate the African regulatory landscape, including the roles of national medicines regulatory authorities, regional bodies, and the African Medicines Agency.
  • You will learn how to detect, document, and report adverse drug reactions using standardised tools and national reporting systems.
  • You will learn how to apply causality assessment methods including the WHO-UMC scale and Naranjo algorithm.
  • You will be able to conduct signal detection using both qualitative and quantitative methods.
  • You will learn how to implement disease-specific pharmacovigilance protocols for HIV/AIDS, malaria, tuberculosis, neglected tropical diseases, and vaccine-preventable diseases.
  • You will be able to apply a health equity lens to pharmacovigilance, including considerations for special populations, pharmacogenomics, and underrepresented communities.
  • You will learn how to design and evaluate hospital- and national-level pharmacovigilance systems appropriate to African contexts.
  • You will be able to engage with emerging issues including digital pharmacovigilance, AI-assisted signal detection, and substandard/falsified medicines surveillance.
  • You will learn how to prepare a professional pharmacovigilance system improvement plan as a capstone deliverable.

Course Content

Introduction to Pharmacovigilance
Module 1 introduces the foundational science and practice of pharmacovigilance. Learners will gain a clear understanding of what pharmacovigilance is, why it exists, how it developed historically, and why it has particular significance for African countries. This module lays the conceptual groundwork for all subsequent content.