IMAIcelandic National Competent Authority. http://www.lyfjastofnun.is/"
Identified riskAn adverse event for which there is adequate evidence of an association with the use of the medicinal product of interest.
Idiosyncratic drug reactionA reaction that occurs rarely and unpredictably in a small percentage of the population in response to a treatment or medicine. These reactions frequently occur with exposure to new medicines and cannot be explained by the known mechanisms of action of the medicine, do not occur at any dose in(...)
ImmunogenicThe ability of a substance to produce an immune response.
ImmunotoxicityImmunotoxicity is harm occurring to the immune system caused by exposure to chemical substances. Testing for immunotoxicity is a standard part of developing substances as potential new medicines. Symptoms of immunotoxicity can include increased rates or severity of infectious diseases or(...)
Impartial WitnessThe role of an impartial witness is to attend the informed consent process if the patient/participant or their legally authorised representative (LAR) cannot read. The impartial witness reads the relevant documentation supplied to the participant (for instance, the consent form). The witness(...)
Implementing ActsFrom the European Commission: An implementing act is a non-legislative act laying down detailed rules allowing the uniform implementation of legally binding Union acts. Implementing powers are conferred in many cases on the European Commission, while in duly justified specific cases and in the(...)
Inactivated vaccineInactivated vaccines use the killed version of the pathogen that causes a disease.
IncidenceThe number of new cases of a health event (such as development of a disease, or reaction to a medicine) that occur during a specific time period, usually a year, in a specified population. Incidence is therefore also a measure of the risk of experiencing the health event during a certain(...)
