Ethical, Regulatory, Legal ResponsibilitiesLimitations on safety profile in clinical trials: pregnant, pediatrics, geriatrics not enrolledAdverse Event: Any untoward medical occurrence in a patient, clinical investigation subject, or consumer who administered an Abbvie product, which could be a drug or medical deviceAn adverse event need not necessarily have a causal relationship with the treatment or usage of an AbbVie product.You need to report the adverse event even if the reporter thinks the adverse event is unrelated to the AbbVie product.Adverse Events: abnormal test findings (elevated liver enzyme), clinical signs and symptoms (sneezing, coughing), changes in physical exam findings (reduced body weight), hypersensitivity (rashes due to drug allergy), worsening of underlying disease (sudden surge in BP), death, hospitalizationAn adverse event is considered serious if it results in death, is life threatening, requires or prolongs hospitalization, results in significant/persistent disability/capacity, is a congenital anomaly/birth defect, medically significant requiring medical or surgical intervention, elective abortion (AbbVie), miscarriage (AbbVie)15 calendar days for SARs and 7 days for fatal/life-threatening events for report to regulatory agencyValid adverse event: identifiable patient (initials, sex, age and age group), reporter (contact info), adverse event/special situation (confirm w HCP whether serious or not), AbbVie product (batch number) Special Situations (circumstances that may increase patients risks of developing adverse events):-Exposure during pregnancy/lactation: maternal exposure (during or after use of AbbVie) or paternal exposure (prior to or around time of conception, during partner pregnancy), obtain pregnancy outcome-Suspected Transmission of an Infectious Agent: contamination of starting materials, during manufacture, inadequate inactivation /attenuation of infectious agents (live vaccines)-Misuse/Abuse/Overdose/Underdose: intentional or unintentional-Lack of effect: therapeutic effect is diminished, the drug is not working-Off-label use with an adverse event: prescribe pharmaceuticals outside the scope of the drugs approved label.-Occupational exposure to the drug-Medication errors (near miss): potential errors: no actual patient has been involved, preventable event that may cause or lead to inappropriate medication use or patient harm. Including prescribing error, dispensing error, administration error, product labelling, packaging and name confusion, wrong preparation and expired products. Reportable even if it was corrected prior to the administration of the product. Other situations: adverse events already in label, occurred weeks/months ago but just recently aware, AEs which HCPs do not want to report, unexpected therapeutic or clinical benefits, inadvertent or accidental exposure w or w/o AEs, product complaints associated with an adverse event.GSK products: Tracium, Ultiva, Mivacron