What Students Need To Know About Reporting Patient Safety Events in Pharamcovigilance.

The U.S. Food and Drug Administration (FDA) defines an adverse drug experience as any AE associated with the use of a drug in humans, whether or not considered drug related, while the International Conference on Harmonisation (ICH) guideline ICH E2A similarly defines an AE as an untoward medical occurrence in a patient administered a pharmaceutical product, whether or not the occurrence is related to or considered to have a causal relationship with the treatment. For marketed products regulated by FDA, AEs are categorized for reporting purposes according to the seriousness and expectedness of the event (i.e., whether the event was previously observed and included in local product labeling), as it is presumed that all spontaneously reported events are potentially related to the product for the purposes of FDA reporting. Prior to marketing approval, relatedness is an additional determinant for reporting events occurring during clinical trials or preclinical studies associated with investigational new drugs a