FAQ Category: Pharmacovigilance

An adverse event requires the evaluation of the presence of the following criteria by the sponsor:

• Is it a serious event?
• Is there reason to suspect a causal relationship with the administration of the investigational medicinal product?
• Is the adverse reaction, by its nature and severity, inconsistent with the reference information for the investigational medicinal product?

If the investigator or the sponsor judges all these criteria to be fulfilled, this constitutes a case of a suspected unexpected serious adverse reaction (SUSAR).

• Death
• Life-threatening
• requires inpatient hospitalization or prolongation of existing hospitalization
• Disability or Permanent Damage
• Congenital Anomaly/Birth Defect
• Important Medical Event (IME): when the event does not fit the other outcomes, but the event may jeopardize the patient and may require medical or surgical intervention (treatment) to prevent one of the other outcomes

An adverse reaction, the nature or severity of which is not consistent with the applicable product information.

A response to a drug which is noxious and unintended, and which occurs at doses normally used in man for the prophylaxis, diagnosis, or therapy of disease, or for the modifications of physiological function.

Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.

Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem. (WHO 2002)