Unexpected Adverse Drug Reaction definition

Unexpected Adverse Drug Reaction means an adverse reaction, the nature or severity of which is not consistent with the applicable product information (e.g. Investigator’s Brochure for an unapproved investigational medicinal product).
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Unexpected Adverse Drug Reaction means an adverse reaction, the nature or severity of which is not consistent with the applicable product information.
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Unexpected Adverse Drug Reaction. ("UADR") means an ADR, the nature or severity of which is not consistent with the applicable product information
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Examples of Unexpected Adverse Drug Reaction in a sentence

  • An Unexpected Adverse Drug Reaction is defined as an adverse reaction, the nature or severity of which is not consistent with the applicable product information.

  • Unexpected Adverse Drug Reaction (abbreviated as UADR) - shall mean such adverse drug reaction the nature, severity or consequences of which are not consistent with the information laid down in the summary of the product characteristics for an authorised medicinal product or which are not consistent with available information, e.g. the investigator's brochure for an investigational medicinal product without marketing authorisation (Section 3, paragraph 4 (b) of the Act).

  • Unexpected Adverse Drug Reaction: An adverse reaction, the nature or severity of which is not consistent with the applicable product information (e.g., Investigator's Brochure for an unapproved investigational medicinal product or package insert/summary of product characteristics for an approved product).

  • Unexpected Adverse Drug Reaction An adverse reaction, the nature or severity of which is not consistent with applicable product reference safety information (Section 6.5 of the Investigator Brochure).

  • It was shown that the proteolytic activity in all yogurt Table 2.

  • Unexpected Adverse Drug Reaction: an adverse reaction, the nature or severity of which is not consistent with the applicable product information (e.g. the Investigator’s Brochure for an unapproved investigational product or the Product Monograph for an approved drug).

  • Unexpected Adverse Drug Reaction: an unexpected Adverse Drug Reaction is “an adverse reaction, the nature or severity of which is not consistent with the applicable product information (e.g., Investigator’s Brochure for an unapproved investigational medicinal product)”.

  • Unexpected Adverse Drug Reaction (U-ADR): an adverse reaction, the nature or severity of which is not consistent with the applicable product information (e.g. the Investigator’s Brochure for an unapproved investigational product or the Product Monograph for a marketed drug).

  • Serious and Unexpected Adverse Drug Reaction (SUADR) SUADRs are SADR that are unexpected, where severity of which is not consistent with the applicable product information of each component of the paste and suspension.All SUADRs will have expedited reporting to regulatory agencies following ICH-GCP and local regulatory requirements.

  • An Unexpected Adverse Drug Reaction is any adverse reaction, the nature or severity of which is not consistent with the applicable product information (e.g. Investigator’s Brochure).


More Definitions of Unexpected Adverse Drug Reaction

Unexpected Adverse Drug Reaction means an adverse reaction, the nature or severity of which is not consistent with the applicable investigational product information.
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Unexpected Adverse Drug Reaction. An Adverse Drug Reaction where the nature and/or severity of the reaction is not consistent with the term or description used in the IB . Unlisted Adverse Drug Reaction: An ADR, the nature, severity, specificity or outcome of which is not consistent with the information included In the applicable CCSI or local equivalent reference label. · Valid Case: A case that includes each of the following minimum criteria: • An identifiable patient; • The name of the suspect Medicinal Product(s) or Clinical Study if considered related to a Clinical Study procedure/design; • An identifiable reporting source; • An event or outcome.
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Unexpected Adverse Drug Reaction. An Adverse Drug Reaction where the nature and/or severity of the reaction is not consistent with the term or description used in the IB. Unlisted Adverse Drug Reaction: An ADR, the nature, severity, specificity or outcome of which is not consistent with the information included in the applicable CCSI or local equivalent reference label.
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Unexpected Adverse Drug Reaction means an adverse reaction with the nature or severity not consistent with the applicable product information;
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Unexpected Adverse Drug Reaction means an adverse reaction with the nature or severity not consistent with the applicable product information; CHAPTER II: APPLICATION, ASSESSMENT, INSPECTION AND REPORTING IN CLINICAL TRIALS
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Unexpected Adverse Drug Reaction means an adverse reaction, the nature, severity or outcome of which is not consistent with domestic labeling, marketing authorization or the SmPC.
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Related to Unexpected Adverse Drug Reaction

  • 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.

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

  • 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.

  • Drug abuse means any pattern of pathological use of drugs that causes impairment in social or occupational functioning, or that produces physiological dependency evidenced by physical tolerance or by physical symptoms when it is withdrawn.

  • 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 decision means any decision by a review agent not to certify an admission,