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).
Sample 1Sample 2
Unexpected Adverse Drug Reaction means an adverse reaction, the nature or severity of which is not consistent with the applicable product information.
Sample 1Sample 2Sample 3
Unexpected Adverse Drug Reaction. ("UADR") means an ADR, the nature or severity of which is not consistent with the applicable product information
Sample 1Sample 2

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. 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.
Sample 1
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.
Sample 1
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.
Sample 1
Unexpected Adverse Drug Reaction means an adverse reaction with the nature or severity not consistent with the applicable product information;
Sample 1
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
Sample 1
Unexpected Adverse Drug Reaction means an adverse reaction, the nature or severity of which is not consistent with the applicable investigational product information.
Sample 1

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 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 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.

  • 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.

  • COVID-19 symptoms means fever of 100.4 degrees Fahrenheit or higher, chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting, or diarrhea, unless a licensed health care professional determines the person’s symptoms were caused by a known condition other than COVID-19.

  • 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.

  • Material Adverse Event means an occurrence having a consequence that either (a) is materially adverse as to the business, properties, prospects or financial condition of the Company or (b) is reasonably foreseeable, and if it were to occur might materially adversely affect the business, properties, prospects or financial condition of the Company.

  • 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.

  • Phase I Clinical Study means a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).

  • 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.

  • Phase III Clinical Study means a trial involving administration of a Compound to sufficient numbers of human patients with the goal of establishing that the Compound is safe and efficacious for its intended use, to define warnings, precautions and adverse reactions that are associated with the drug or label expansion of such Compound, and to be considered as a pivotal study for submission of an NDA.

  • Phase II Clinical Study means a human clinical study of a product initiated to determine the safety and efficacy in the target patient population, as described 21 C.F.R. 312.21(b).

  • Phase I Trial means a Clinical Trial, the principal purpose of which is preliminary determination of safety of an investigational product in healthy individuals or patients or that otherwise meets the requirements described in 21 C.F.R. §312.21(a), or similar Clinical Trial in a country other than the United States.

  • Phase I Clinical Trial means a human clinical trial that is intended to initially evaluate the safety and/or pharmacological effect of a Product in subjects or that would otherwise satisfy requirements of 21 C.F.R. 312.21(a), or its foreign equivalent.

  • 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,

  • Clinical Study means a Phase I Study, Phase II Study, Phase III Study, as applicable.

  • Phase II Clinical Trial means a controlled human clinical study that would satisfy the requirements of 21 CFR 312.21(b), conducted to study the effectiveness and establish the dose range of a Product for a particular Indication in patients with the disease or condition under study, including a Phase IIA Clinical Study or Phase IIB Clinical Study.

  • Phase III Clinical Trial means a human clinical trial of a product, the design of which is acknowledged by the FDA to be sufficient for such clinical trial to satisfy the requirements of 21 C.F.R. 312.21(c) (as amended or any replacement thereof), or a similar human clinical trial prescribed by the Regulatory Authority in a country other than the United States, the design of which is acknowledged by such Regulatory Authority to be sufficient for such clinical trial to satisfy the requirements of a pivotal efficacy and safety clinical trial.

  • Phase IV Clinical Trial means a product support clinical trial of a Product commenced after receipt of Regulatory Approval in the country where such trial is conducted. A Phase IV Clinical Trial may include epidemiological studies, modeling and pharmacoeconomic studies, and investigator-sponsored clinical trials studying Product that are approved by the JDC and that otherwise fit the foregoing definition.

  • Phase IIb Clinical Trial means a clinical trial of a Product on sufficient numbers of patients that is designed to provide a preliminary determination of safety and efficacy of such Product in the target patient population over a range of doses and dose regimens.

  • Regulatory Disruption Any event that Dealer, based on the advice of counsel, determines makes it reasonably necessary or appropriate with regard to any legal, regulatory or self-regulatory requirements or related policies and procedures that generally apply to transactions of a nature and kind similar to the Transaction and have been adopted in good faith by Dealer for Dealer to refrain from or decrease any market activity in connection with the Transaction. Settlement:

  • Regulatory Problem means any set of facts or circumstance wherein it has been asserted by any governmental regulatory agency (or a Regulated Stockholder reasonably believes that there is a risk of such assertion) that such Regulated Stockholder is not entitled to acquire, own, hold or control, or exercise any significant right (including the right to vote) with respect to, any Equity Securities of the Company or any subsidiary of the Company.

  • Phase III Trial means a Clinical Trial of an investigational product in subjects that incorporates accepted endpoints for confirmation of statistical significance of efficacy and safety with the aim to generate data and results that can be submitted to obtain Regulatory Approval as described in 21 C.F.R. 312.21(c), or a comparable Clinical Trial prescribed by the relevant Regulatory Authority in a country other than the United States.

  • Diagnosis means the definition of the nature of the Client's disorder. When formulating the Diagnosis of Client, CONTRACTOR shall use the diagnostic codes and axes as specified in the most current edition of the DSM published by the American Psychiatric Association. DSM diagnoses will be recorded on all IRIS documents, as appropriate.