Suspected Adverse Drug Reaction definition

Suspected Adverse Drug Reaction means a noxious and unintended response to any dose of the Shire Product for which there is a reasonable possibility that the Shire Product caused the response. In this definition, the phrase “a reasonable possibility” means that the relationship cannot be ruled out.
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Suspected Adverse Drug Reaction means a noxious and unintended response to any dose of the Product for which there is a reasonable possibility that the Product caused the response. In this definition, the phrase “a reasonable possibility” means that the relationship cannot be ruled out. “Territory” has the meaning given to it in the Acquisition and License Agreement. “Unexpected Suspected Adverse Drug Reaction” means any Suspected Adverse Drug Reaction that is not included in the current U.S. labeling for the Product. “Valid Safety Reports” means the minimum information required for expedited reporting which should at least include all of the following:
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Examples of Suspected Adverse Drug Reaction in a sentence

  • Once an Adverse Event or a Suspected Adverse Drug Reaction has been identified, Shire will assess it according to seriousness and where appropriate report it as a literature report quoting the reference for the article for onward reporting to the appropriate Regulatory Authority in the Territory.

  • This will be reported as a Suspected Adverse Drug Reaction (SADR).• Definitely related: Temporal relationship to SM administration is plausible, and concurrent disease or other drugs or chemicals cannot explain event.

  • The initial term of this Agreement shall be for (5) years commencing on March 1, 2014 and upon mutual agreement, will be renewable for up to (2) two additional terms of (5) five year periods.

  • If the initial capacity of The Village Charter School is insufficient to enroll all prospective students, a lottery, following Idaho Code § 33-5025(3)(k), will be utilized to determine which prospective students will be admitted to TVCS.

  • Overall expected Outcomes: Improved reporting of suspected adverse drug reactions and poor quality medicinal products (evaluated by numbers of Suspected Adverse Drug Reaction [SADR] & Poor Quality Medicinal Products [PQMP]); improved capacity of health care workers to identify and report SADRs and PQMPs; improved awareness by health care workers and the public on medicine safety Activity 13: Support to PV data acquisition, management and useThe following sub-activities will be implemented.

  • Occasional : Transient stinging on instillation.Rare : Allergic reaction (persistent burning, swelling of lids) Also see current BNF.In the event of a Suspected Adverse Drug Reaction, please complete a Yellow card and submit to the MHRA.

  • In the event of a Suspected Adverse Drug Reaction, please complete a Yellowcard and submit to the MHRA or on the website at www.yellowcard.gov.uk .

  • EudraVigilance - European Database of Suspected Adverse Drug Reaction Reports.

  • In the event of a Suspected Adverse Drug Reaction, please complete a Yellowcard and submits to the MHRA.

  • In the event of a Suspected Adverse Drug Reaction, please complete a YellowCard and submit to the MHRA or on the website at www.yellowcard.gov.uk .

Related to Suspected 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.

  • 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.

  • 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.

  • Biological Material means any material containing genetic information and capable of reproducing itself or being reproduced in a biological system;

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

  • 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).

  • 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 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.

  • 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.

  • 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.

  • DXC Sensitive Information means DXC Confidential Information, Intellectual Property, PHI, DXC Customer data, and Personal Information.

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

  • Investigational Product means the Study Drug identified above and the control material, as further detailed in the Protocol;

  • 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).

  • 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.

  • 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.

  • Substance abuse means alcohol and/or drug abuse, addiction or dependency.

  • Commercially Sensitive Information means the Information (i) listed in the Commercially Sensitive Information Schedule; or (ii) notified to the Authority in writing (prior to the commencement of this Contract) which has been clearly marked as Commercially Sensitive Information comprised of information:

  • Study means the investigation to be conducted in accordance with the Protocol.

  • 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.