Serious or Unexpected Adverse Drug Experience definition

Serious or Unexpected Adverse Drug Experience means any adverse drug experience occurring at any dose that results in any of the following outcomes: death, a life-threatening adverse drug experience, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered a Serious or Unexpected Adverse Drug Experience when, based upon appropriate medical judgment, they may jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the outcomes listed in this definition as more fully defined in 21 C.F.R. (Section 314.80 or Section 600.80, as applicable). An unexpected adverse drug experience means any drug experience that is not listed in the current labeling for the drug product. This includes events that may be symptomatically and pathophysiologically related to an event listed in the labeling, but differ from the event because of greater severity or specificity. Unexpected refers to an adverse drug experience that has not previously been observed (i.e., not included in the labeling) rather than from the perspective of not being anticipated from the pharmacological properties of the pharmaceutical product.

Related to Serious or Unexpected Adverse Drug Experience

  • Serious Adverse Event means any adverse event that led to any of the following:

  • Adverse Drug Experience means any of: an “adverse drug experience,” a “life-threatening adverse drug experience,” a “serious adverse drug experience,” or an “unexpected adverse drug experience,” as those terms are defined at either 21 C.F.R. § 312.32 or 21 C.F.R. § 314.80.

  • Adverse drug reaction means any undesirable or unexpected medication related event that requires discontinuing a medication or modifying the dose, requires or prolongs hospitalization, results in disability, requires supportive treatment, is life-threatening or results in death, results in congenital anomalies, or occurs following vaccination.

  • Clinical experience means providing direct services to individuals with mental illness or the provision of direct geriatric services or special education services. Experience may include supervised internships, practicums, and field experience.

  • Adverse Event means any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and that does not necessarily have a causal relationship with the treatment. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.

  • Serious health condition means an illness, injury, impairment, or physical or mental condition that involves:

  • Acute toxicity means concurrent and delayed adverse effects that result from an acute exposure and occur within any short observation period, which begins when the exposure begins, may extend beyond the exposure period, and usually does not constitute a substantial portion of the life span of the organism.

  • Adverse reaction means an unexpected outcome that threatens the health or safety of a patient as a result of a medical service, nursing service, or health-related service provided to the patient.

  • Specific, adverse impact means a significant, quantifiable, direct, and unavoidable impact, based on objective, identified, and written public health or safety standards, policies, or conditions as they existed on the date the application was deemed complete.

  • Adverse decision means a decision reducing,

  • Teaching Experience means full-time employment as a teacher in a public school, private school licensed or accredited by the State Board of Education, or institution of higher education,

  • Serious harm means harm, whether physical or

  • Final Adverse Benefit Determination means an adverse benefit determination that is upheld at the completion of a health plan issuer’s internal appeals process.

  • Infectious Disease means an illness that is capable of being spread from one individual to another.

  • Serious means violations that either result in one or more neg- ative outcomes and significant actual harm to residents that does not constitute imminent danger, or there is a reasonable predictability of recurring actions, practices, situations, or incidents with potential for causing significant harm to a resident, or both.

  • Mental, Nervous or Psychological Disorder means a mental or nervous health condition including, but not limited to: anxiety, depression, neurosis, phobia, psychosis; or any related physical manifestation.

  • Material Adverse Event means any circumstance or event that, individually or collectively with other circumstances or events, may reasonably be expected to have a material adverse effect on the financial condition or Business of the Borrower, as now conducted or as proposed to be conducted.

  • Final Adverse Determination means an Adverse Determination involving a Covered Service that has been upheld by Blue Cross and Blue Shield or its designated utilization review organization, at the completion of Blue Cross and Blue Shield's internal grievance process procedures.

  • Adverse System Impact means a negative effect that compromises the safety or reliability of the electric distribution system or materially affects the quality of electric service provided by the electric distribution company (EDC) to other customers.

  • Serious Mental Illness . means the following mental disorders as classi­

  • Imminent health hazard means a significant threat or danger to health that is considered to exist when there is evidence sufficient to show that a product, practice, circumstance, or event creates a situation that requires immediate correction or cessation of operation to prevent injury based on the number of potential injuries and the nature, severity, and duration of the anticipated injury or illness.

  • Inherited Metabolic Disorder means a disease caused by an inherited abnormality of body chemistry that meets all of the following requirements:

  • Clinical evaluation means a systematic and planned process to continuously generate, collect, analyse and assess the clinical data pertaining to a device in order to verify the safety and performance, including clinical benefits, of the device when used as intended by the manufacturer;

  • Adverse impact on visibility means visibility impairment which interferes with the management, protection, preservation or enjoyment of the visi- tor’s visual experience of the Federal Class I area. This determination must be made on a case-by-case basis taking into account the geographic extent, in- tensity, duration, frequency and time of visibility impairment, and how these factors correlate with (1) times of vis- itor use of the Federal Class I area, and(2) the frequency and timing of natural conditions that reduce visibility.

  • Congenital Anomaly means a condition which is present since birth, and which is abnormal with reference to form, structure or position.

  • Small disadvantaged business concern means a small business concern that represents, as part of its offer that—