World OF DRUG SAFETY MODULE

There are two types of adverse event reports for approved drug or biologic products: expedited 15-day alert reports and non-expedited adverse event reports that are included in periodic safety reports. The most important is the 15-day alert report. These reports have foreign or domestic origins. These alerts report anything that meets the regulatory definition of a serious and unexpected adverse event. Serious adverse events are defined as:

• Anything that leads to death.
• Anything that leads to a life-threatening adverse experience.
• Anything that leads to inpatient hospitalization.
• Anything that can prolong hospitalization.
• Anything that leads to a persistent or significant disability or incapacity.
• Anything that can cause a congenital anomaly.
• Anything that can require intervention, which if that intervention had not occurred, would have resulted in one of the events already mentioned.