An ongoing assessment of the benefit-risk profile of products based on the collection and collation of reports of adverse events, from whatever the source.
Adverse Event (AE)
Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a casual relationship with its treatment. An AE can therefore be any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.
Serious Adverse Event (SAE)
Any untoward medicinal occurrence that at any dose:
Adverse Events Include
FDA Reporting Requirements
Lean Principles for Case Handling
Focused on Thoroughness, Integrity, Timely