White paper - Safety Studies

The benefit-risk profile of a medicine is monitored during its whole life cycle. In the post-marketing setting, safety studies (sometimes referred as phase-IV studies) can be conducted as a complement to routine pharmacovigilance activities, to further investigate the safety profile of a medicine. For instance, safety studies can be carried out to obtain additional information on a safety signal identified during clinical trials or via adverse events reported spontaneously by patients and healthcare professionals. Hence, safety studies are an important method of ensuring patients´ safety and wellbeing.