Learn by doing
Move from theory to practice with hands-on training in case series causality assessment.
National and regional pharmacovigilance centre staff have priority on our courses. If you can’t access any of the self-paced courses on our learning platform, write to us at support@who-umc.org.
Building on what you have learnt in our self-paced online courses, this instructor-led online course deepens your understanding and skills in how to assess a group of ICSRs with the same drug and ADR through practical exercises that put your newfound knowledge to the test.
Who is this course for?
Staff from national or regional pharmacovigilance centres who have access to VigiLyze and meet the entry requirements.
How will it help me?
Guided by an instructor, you will turn theory into practice, taking a structured approach to case series causality assessment that you can then apply in your own work.
What are the learning objectives?
- Build a case series based on a drug-ADR combination selected by UMC using VigiLyze
- Choose WHO-UMC causality assessment categories for individual cases
- Apply case series causality assessment following a set of questions and the Bradford Hill criteria
- Use VigiLyze to find relevant information about a drug-ADR combination
Practical exercises in case series causality assessment – what you can expect
As a participant on this course, you will gain experience in assessing a real-world drug-ADR combination by learning how to identify relevant cases in VigiLyze and analyse the case series using Bradford Hill criteria.
You will be expected to complete three assignments and will receive constructive feedback from UMC instructors on your work and areas for improvement. You will need to attend weekly group meetings with your class to discuss that week’s assignment. We also offer optional Q&A sessions throughout the course.
Dates: 2-23 September 2024
Duration: Three weeks part-time. The course takes roughly 25 hours to complete
Cost: Free of charge
Places (max): 20
Application deadline: 5 August 2024
To apply for this course, you must work for a national or regional pharmacovigilance centre and have successfully completed the self-paced courses listed below by 5 August 2024.
With these courses we were able to gain new knowledge and exchange experiences with international experts while doing our regular work. As a result, we now approach signal detection and causality assessment with much more confidence.
Veselinka Vukićević Head of Pharmacovigilance Department, Institute for Medicines and Medical Devices, Montenegro.
Compulsory learning path
