Reporting of AE cases by health professionals and pharmaceutical companies which does not derive from a study or any organized data collection scheme (i.e. is

Reports derived from organized data collection systems, including: Clinical trials Clinical registries Post-approval patient use programs Patient support programs Patient disease management programs Surveys of

Evaluation of the data supporting a detected signal to verify that there is sufficient evidence demonstrating a new potentially causal association, or a new aspect

A set of activities performed to determine whether there are signals associated with medicinal product (based on ICSRs, data from active surveillance systems or studies,

Reported information on a new possible causal relationship (or a new aspect of a known relationship) between an adverse event and a drug. A signal

This part of an RMP provides a synopsis of a medicinal product’s safety. It should be a summary of: The important identified risks Important potential

An important identified risk, important potential risk or important missing information. Medicinal product safety concerns are identified, characterized, and monitored in the DSUR, RMP and

Evidence of an absence of harm (not absence of evidence of harm). Judgement about safety takes into account the degree to which a given risk is acceptable.

results in death requires patient hospitalization results in persistent or significant disability or incapacity is life-threatening or is a congenital anomaly/birth defect. “Severe” describes the