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

  • 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.

  • A patient profile must be maintained and counseling must be provided for each person according to Regulation 5.0.9.12 Suspected Adverse Drug Reaction.

  • Suspected Adverse Drug Reaction Reporting Form: Refer to Chapter 4, and topic 4.1 along with “Annex A”2.

  • Digital practices can help to relieve some of the pressure under which the public service system is currently working.

  • 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 .

  • 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.

  • 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 by Duramed to the appropriate Regulatory Authority in the Territory.

  • They omit, however, related data from UK Medicines and Healthcare products Regulatory Agency.[UK Suspected Adverse Drug Reaction (ADR) Analysis Influenza antivirals - oseltamivir (Tamiflu) and zanamivir (Relenza) 29 October 2009] A table, or possibly a Venn diagram, could help.

  • 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.

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.

  • Investigational Medicinal Product means the study drug or control material as defined in the Protocol.

  • 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 of a Licensed Product in human patients conducted primarily for the purpose of determining the safety, tolerability and preliminary activity of the Licensed Product, including, without limitation, for determining the maximum tolerated dose, or optimal dose. For purposes of this Agreement, a Phase I trial shall specifically exclude a study in healthy volunteers.

  • 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 taken as a whole or (b) is reasonably foreseeable, has a reasonable likelihood of occurring and, if it were to occur, would materially adversely affect the business, properties, prospects or financial condition of the Company taken as a whole.

  • 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.

  • relevant material means any information, document or thing that in the opinion of SARS is [forseeably] foreseeably relevant for the administration of a tax Act as referred to in section 3;’’;

  • Phase I Clinical Trial means a clinical trial conducted in healthy humans or patients, which clinical trial is designed to establish the safety, drug-drug interactions and/or pharmacokinetics of an investigational drug given its intended use, and to support continued testing of such drug in Phase II Clinical Trials.

  • Clinical Study means a Phase I Study, Phase II Study, Phase III Study, or Pivotal Study, as applicable; but excluding any Post-Approval Studies.

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

  • Phase III Clinical Study means a human clinical study of a product on a sufficient number of subjects that is designed to establish that such product is safe and efficacious for its intended use, and to determine warnings, precautions, and adverse reactions that are associated with such product in the dosage range to be prescribed, which trial is intended to support Regulatory Approval of such product, as described in 21 C.F.R. 312.21(c). 1.185. [***] 1.186. [***]

  • 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.

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

  • Phase IV Clinical Trial means a Clinical Trial conducted after a Product achieves Regulatory Approval, carried out for purposes of conducting safety surveillance and ongoing technical support of the Product.

  • Clinical Trial means a Phase I Clinical Trial, Phase II Clinical Trial or Phase III Clinical Trial, or any post-approval human clinical trial, as applicable.

  • Nonconformity or “Nonconformities” means any failure or failures of the Software to conform to the requirements of this Contract, including any applicable Documentation.

  • 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.