A Serious Adverse Reaction (SAR) is an adverse reaction to a medicinal product that meets specific criteria of severity. It is characterized by one or more of the following conditions: the reaction results in death, is life-threatening, necessitates in-patient hospitalization or extends an existing hospital stay, leads to persistent or significant disability or incapacity, or involves the occurrence of a congenital anomaly or birth defect.
The term “reaction” signifies that there is at least a reasonable possibility of a causal relationship between the medicinal product and the adverse event. SARs are of significant concern in pharmacovigilance and require careful evaluation and reporting to ensure patient safety.
Confounding by Indication
Contact our experts today
Composed of proven experts from the pharmaceutical industry, our team is ready to answer to your needs in any
area of product development, commercialisation and early access programs, and life cycle management