Pharmacovigilance trainings

Pharmacovigilance trainings

WHO Nepal
National training on adverse event following immunization (AEFI) and vaccine safety surveillance held in Bagmati Province, Nepal
© Credits

The WHO Pharmacovigilance team supports countries with a broad range of trainings that can be customized to local context for establishing and strengthening national pharmacovigilance systems based on collaboration, a product lifecycle approach and the best use of available resources.

Pharmacovigilance Inspections 

This training course provides the learner an introduction to the organization, planning, conduct, reporting and follow-up of pharmacovigilance inspections, to regulatory authority personnel who will be involved or who are already involved in pharmacovigilance inspections.

Practical guidance on Anaphylaxis

This is practical guidance on anaphylaxis that provides insights on the identification, management and follow up in a primary care setting. The step-by-step guidance offered enables the learner to differentiate anaphylaxis from fainting. It also provides guidance on the contents and usage of "emergency kits" that need to be kept at all centers where vaccines are administered.

Vaccine Safety Basics

This course introduces participants to the foundations of vaccine pharmacovigilance. The aim of this course is to provide healthcare professionals whose work involve vaccine safety issues, with essential knowledge about vaccines and their safety aspects. These professionals can include nurses, midwives, community health workers, as well as pharmacists, medical doctors and immunization programme or vaccine safety communication officers. The course is available in English, French, Russian and Spanish.

AEFI Data management basics

In this course, first, the learner visits the island country of Harmonia and understands the organizational structure of its health system as well as the different human actors and their roles in the vaccine safety crisis that unfolds in the course. Next, the learner will manage the AEFI cluster of cases that occur in Harmonia and will review the different aspects of an electronic AEFI data management system. Finally, the learner will learn how the data entered in the electronic AEFI data management system is converted to graphs, tables, and line lists, how the data are reviewed and monitored at the various levels and how key decisions are made.

AEFI Investigation

WHO takes the learner on a journey to Africa, Europe and Asia where serious AEFI cases are reported, to: 

  • decide when to launch an AEFI investigation
  • list what information is required to successfully complete an AEFI Investigation Report Form and investigation dossier
  • decide when, what and how may be best to communicate with involved parties during an investigation.

AEFI causality assessment

Part A: AEFI Causality Assessment – Understanding the principles and philosophies :The learner explores the different facets and challenges of AEFI causality assessment and practices assessing causality for serious AEFI cases with step-by-step guidance explaining the logic of the decisions taken. “Difficult”  questions are answered by an expert through the Chatbot.

Part B:  AEFI Causality Assessment – Software training: For users of the AEFI causality assessment software, this eLearning course explores its various features, teaches how to do an AEFI causality assessment online an also certifies the users' skills. 

Communication - Vaccine Safety Basics

This course is in Chinese and will help users to understand how public fears and concerns about vaccines and immunization can improve your skills in vaccine safety communication.

Pharmacovigilance training packages

They are available upon request: Trainings provided in countries requesting more advanced support, e.g., to build the capacity of an AEFI review committee, Periodic Safety Update Reports (PSUR) training, training for AEFI signal detection.

Stay tuned: more courses to come!

Risk management plan and Periodic safety update reports

Course using the material produced during a WHO virtual pharmacovigilance workshop on periodic safety update reports (PSUR) and risk management plan (RMP) assessments, held in 2020.

Vaccine Safety Crisis Communication

This course is under development in collaboration with WHO EURO. Using an adult gaming approach this course aims to build the capacity of learners on using simple communication approaches and strategies when responding to a vaccine safety crisis thus preventing to from  escalating to unmanageable proportions that can cause lasting damage to immunization programs.

Active surveillance 

Resources addressing the safety monitoring of new COVID-19 vaccines and therapeutics, safety monitoring in pregnancy and criteria for good practices on safety communication compose the content of this course for health-care professionals and frontline health workers in settings with limited resources.