This e-course is designed to help all participants to successfully conduct Active Safety Surveillance studies in their countries. The different modules in the course target the various actors with different roles in conducting a study, such as health care professionals, study staff, staff from national pharmacovigilance centres, immunization and disease programmes, as well as principal investigators and academics.
Language: English
Health topic, Intermediate (Intermediaire)
Course information
Overview
Adverse events following immunization (AESIs) pose a significant risk to patient safety and public health. Studies in Europe showed that ADRs account for 3.7% of hospital admissions and affect 10.1% of hospitalized patients. The situation is potentially worse in low- and middle-income countries due to limited resources for managing ADRs. Furthermore, existing spontaneous reporting systems often suffer from underreporting, making it difficult to accurately assess the incidence and severity of adverse events.
Pharmacovigilance involves detecting, assessing, understanding, and preventing adverse effects and other medicine- or vaccine-related issues. It supports health care professionals in prioritizing treatment benefits over risks, enhances patient care by providing critical data, and reduces economic burdens by minimizing ADR frequency and impact. This also promotes rational medicine use, treatment adherence, and public confidence.
To enhance pharmacovigilance efforts, active safety surveillance studies are implemented. These involve systematic, continuous processes for collecting case safety information proactively. Unlike routine methods which rely on voluntary reporting, active safety surveillance employs organized efforts such as regular follow-ups, direct patient inquiries, and comprehensive medical record reviews. This pre-organized approach ensures timely identification of adverse events, particularly in real-world settings, and is crucial for understanding the safety profiles of new products and monitoring special populations.
Course duration
5 hours
Certificate
A Certificate of Participation will be available for this e-course.
What you'll learn
- Define pharmacovigilance and its role in monitoring medicine and vaccine safety.
- Explain the need for active safety surveillance alongside passive methods for timely risk identification and management.
- Design the structure of a training module for background of a study medicine or vaccine.
- Describe key epidemiology methods (cross-sectional, case-control, case-only) for safety surveillance.
- Explain the ethical principles relevant to active safety surveillance and how to address ethical issues in practice, especially in vulnerable populations.
Who this course is for
- This e-course has been designed for the different actors involved in conduction active safety surveillance studies: health care professionals; study staff; staff from national pharmacovigilance centres, immunization programmes, disease programmes; principal investigators; academics; other health care professionals at study sites.
Course contents
Course introduction:
An introduction to this course on implementing active safety surveillance for medicines and vaccines.Module 1: Introduction to pharmacovigilance
Module 2: Examples of medicines and vaccines with WHO CEM protocols:
This module will outline and explain the background information study staff should know about a study medicine or vaccine.Module 3: Other methodological approaches for pharmacovigilance observational studies :
This module will provide a background on different epidemiology methods – other than cohort event monitoring (CEM) – that can be used for safety surveillance.Module 4: Cohort event monitoring (CEM):
This module will provide information on cohort event monitoring (CEM) studies.Module 5: Adapting the WHO protocols for active safety surveillance:
This module will address how to conduct an active safety surveillance study in your country using the WHO protocols.Module 6: Ethical considerations:
This module will provide an overview of ethical considerations in active safety surveillance.Module 7: Collecting baseline information and follow-up :
This module will provide information on the data collection process for active safety surveillance.Module 8: Conducting active safety surveillance in pregnant and breastfeeding women:
This module will look at medicine and vaccine safety surveillance in pregnant and breastfeeding women.Module 9: Statistical analysis plan for cohort event monitoring:
This module will explore the statistical analysis plans used in cohort event monitoring (CEM).Course close
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Certificate Requirements
- Gain a Confirmation of Participation by completing at least 80% of the course material.
- Gain an Open Badge by completing the course.