Fernanda Borrazas

Serious adverse event narratives: background and definitions Before defining case narrative, it is important to explain the concept of Individual Case Safety Report (ICSR); this well-known pharmacovigilance report captures information about adverse events and product problems that are reported to public health, patient safety/quality improvement organizations or regulatory agencies. The ICSR message supports reporting from a variety of sources such as consumers, hospitals, contract research...

Introduction The safety of drugs is of paramount importance to patients and healthcare professionals. The pharmaceutical industry has an...

Pharmacoepidemiology definition Pharmacoepidemiology is the study of the utilization and effects of drugs in large numbers of people; it...