Learning unit: Pharmacovigilance


Impact of the learning unit:

The pharmacotherapy is associated with a risk of adverse effects. The aim of the learning unit is
to familiarize the student with the generally valid and legally binding procedures of
pharmacovigilance, i.e. monitoring and reporting of adverse drug reactions.


Relevant terms

phamacovigilance

adverse reaction

adverse effect

serious adverse effect

unexpected adverse effect

suspicion of severe and unexpected adverse effect

EudraVigilance

regulatory authority

clinical trial phase IV


Learning outcomes

The student distinguishes between serious and non-serious, between expected and unexpected adverse
effect of drugs.

The student is able to describe the characteristics of a phase IV clinical trial of medicinal
products. The student enumerates subjects involved in the system of collecting and evaluating
information about the adverse effects of drugs and can describe the role of the physician and his
responsibilities in this system.


Study literature

http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000679.jsp&mid
=WC0b01ac05800250b5

http://www.sukl.eu/medicines/pharmacovigilance

CIOMS form https://cioms.ch/wp-content/uploads/2018/09/CIOMS-to-E2B-1.pdf

FDA form https://www.accessdata.fda.gov/scripts/MedWatchLearn/adverse_effects/default.htm


Exam questions

General pharmacology: 23. Pharmacovigilance, drug safety, advertisement and marketing on the field
of therapeutics, ethical issues