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.

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

  • 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.

  • 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.

  • 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 .

  • Enhancing Communication about Paediatric Medicines: Lessons from a Qualitative Study of Parents' Experiences of Their Child's Suspected Adverse Drug Reaction.

  • 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.

  • 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.

  • The SEEA Central Framework allows for the measurement of physical flows and stocks while providing guidance on the valuation of renewable and non-­‐‑renewable natural resources and land within the System of National Accounts (SNA) asset boundary.

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

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.

  • 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, as to a particular Licensed Product, an initial clinical study in humans with the purpose of assessing the Licensed Product’s safety, tolerability, toxicity, pharmacokinetics or other pharmacological properties.

  • 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 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.

  • 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 I Clinical Trial means a study in humans which provides for the first introduction into humans of a product, conducted in normal volunteers or patients to generate information on product safety, tolerability, pharmacological activity or pharmacokinetics, or otherwise consistent with the requirements of U.S. 21 C.F.R. §312.21(a) or its foreign equivalents.

  • 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.

  • 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.

  • 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 BMS and that otherwise fit the foregoing definition.

  • 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.

  • 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.