learn by doing

Case series causality assessment

Building on what you have learnt in our self-paced online courses about analysis of PV data, this instructor-led online course deepens your understanding and skills in how to assess a case series, which is a group of ICSRs with the same medicine and adverse event, through exercises that put your 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 you will learn

By the end of this course, you will be able to:
  • Build a case series based on a medicine-adverse event 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 medicine-adverse event combination

Hands-on, instructor-led course – what you can expect

As a participant in this online course, you will gain experience in assessing a real-world medicine-adverse event 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.

To apply for this course, you must meet the following requirements:

  • Dates: To be determined
  • Location: Online
  • Duration: Three weeks part-time. The course takes roughly 25 hours to complete.
  • Target audience: Employees at national or regional PV centres that are members of the WHO PIDM.
  • Language: English
  • Award: Yes
  • Cost: Free of charge
  • Places (max): 20
  • Application deadline: Closed

Compulsory learning path

Additional recommended pre-study

MedDRA

During this course, you will use MedDRA terminology. If you have limited knowledge about MedDRA, we strongly recommend learning more about this terminology through the online training options offered by the
Maintenance and Support Services Organization (MSSO) in several languages. You can also use the MedDRA Training Roadmap as a starting point. Topics such as safety data analysis and Standardised MedDRA Queries (SMQs) are included in the material.

VigiBase

During this course, you will analyse VigiBase data. To understand what kind of data is available in VigiBase, where it comes from, and what limitations it has, we recommend that you take the UMC self-paced VigiBase – Introductory course.

“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