Serious ADEs definition

Serious ADEs shall have the meaning set forth in Section 5.1.
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Serious ADEs means, any adverse drug event occurring at any dose that results in any of the following outcomes: Death, a life-threatening adverse drug event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered a serious adverse drug event when, based upon appropriate medical judgment, they may jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the outcomes listed in this definition. Examples of such medical events include allergic bronchospasm requiring intensive treatment in an emergency room or at home, blood dyscrasias or convulsions that do not result in inpatient hospitalization, or the development of drug dependency or drug abuse. “Unexpected ADEs” means, any adverse drug event that is not listed in the current labeling for the Product. This includes events that may be symptomatically and pathophysiologically related to an event listed in the labelling, but differ from the event because of greater severity or specificity. The roles and responsibilities of each Party in respect of ADE’s shall be specified in the Technical Agreement attached as Schedule E.
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Serious ADEs means, with respect to a serious adverse event or reaction, is any noxious and unintended response to a drug that at any dose: ● requires in-patient hospitalization or prolongation of existing hospitalization; ● causes congenital malformation; ● results in persistent or significant disability or incapacity; ● is a congenital anomaly/birth defect; ● is a medically important event or reaction; ● results in death; or ● is life-threatening.
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Examples of Serious ADEs in a sentence

  • Each of Cipher and Distributor and their respective Affiliates, SubDistributors, Approved Manufacturers, agents or other relevant parties shall inform the other of all known or suspected ADE’s associated with the Product in the Territory, of which it is notified, or otherwise becomes aware, as soon as reasonably possible but in any event quarterly for ADE’s and within seven (7) days for Serious ADEs and Unexpected ADE’s or within any time limits required by applicable Law, whichever is shorter.

  • Therefore, the farm must carry workers’ compensation for “volunteers” as if they were employees.

  • Serious ADEs were associated with the indication for which the drug was prescribed, the duration of the ADE and the need to administer treatment for the ADE at the reporting facility.

  • Each of Can-Xxxx and Distributor and their respective Affiliates, SubDistributors, Approved Manufacturers, agents or other relevant parties shall inform the other of all known or suspected ADE’s associated with Supplied Product, of which it is notified, or otherwise becomes aware, as soon as reasonably possible but in any event within ten (10) days for ADEs and forty-eight (48) hours for Serious ADEs or within any time limits required by applicable Law, whichever is shorter.

Related to Serious ADEs

  • Serious harm means harm, whether physical or

  • Serious assault means an act that constitutes a felony violation of chapter XI of the Michigan penal code, 1931 PA 328, MCL 750.81 to 750.90h, or that constitutes an assault and infliction of serious or aggravated injury under section 81a of the Michigan penal code, 1931 PA 328, MCL 750.81a.

  • Serious crime means conduct constituting an offence punishable by a maximum deprivation of liberty of at least four years or a more serious penalty;

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

  • Serious health condition means an illness, injury, impairment, or physical or mental condition that involves:

  • Serious physical harm means bodily injury that involves a substantial risk of death, extreme physical pain, protracted and obvious disfigurement, or protracted loss or impairment of the function of a bodily member, organ, or mental faculty.

  • Serious illness means an accident, injury, illness, disease, or physical or mental condition that: poses imminent danger of death; requires inpatient care in a hospital, hospice, or residential medical facility; or requires continuing in-home care under the direction of a physician or health care provider. Related current definitions are summarized in (f) below.

  • serious criminal offence means an offence which corresponds or is equivalent to one of the offences referred to in Article 2(2) of Framework Decision 2002/584/JHA, if it is punishable under national law by a custodial sentence or a detention order for a maximum period of at least three years;

  • Serious violation means OCC has made a valid finding when assessing a serious complaint that alleges:

  • Serious damage ’ means any specific defect defined in this section; or an equally objectionable variation of any one of these defects, any other defect, or any combination of defects which se- riously detracts from the appearance, or the edible or marketing quality of the fruit. The following specific defects shall be considered as serious damage:

  • Serious offense means any of the following felonies or a felony attempt to commit any of the following felonies, as now existing or hereafter amended:

  • serious offence means: (a) a crime or offence involving the death of a person; (b) a sex-related offence or a crime, including sexual assault (whether against an adult or child); child pornography, or an indecent act involving a child; (c) fraud, money laundering, insider dealing or any other financial offence or crime, including those under legislation relating to companies, banking, insurance or other financial services; or (d) an attempt to commit a crime or offence described in (a) to (c);

  • Serious traffic violation means a conviction when operating a commercial motor vehicle of:

  • Serious means violations that either result in one or more neg- ative outcomes and significant actual harm to residents that does not constitute imminent danger, or there is a reasonable predictability of recurring actions, practices, situations, or incidents with potential for causing significant harm to a resident, or both.

  • Serious Breach means any breach defined as a Serious Breach in the Agreement or any breach or breaches which adversely, materially or substantially affect the performance or delivery of the Services or compliance with the terms and conditions of the Agreement or the provision of a safe, healthy and supportive learning environment or a breach of security that adversely affects the Personal Data or privacy of an individual. Failure to comply with Law, or actions or omissions by the Provider that endanger the Health or Safety of Learners, Provider Personnel, and all other persons including members of the public would constitute a Serious Breach;

  • Serious Mental Illness . means the following mental disorders as classi­

  • serious incident means any incident that directly or indirectly led, might have led or might lead to any of the following:

  • Likelihood of serious harm means either: (a) A substantial

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

  • Noxious weed means a weed defined in 7-22-2101.

  • Serious Misconduct means any misconduct identified as a ground for termination in the Motorola Code of Business Conduct, or the human resources policies, or other written policies or procedures.

  • Mysterious Disappearance means any disappearance of Property which, after a reasonable investigation has been conducted, cannot be explained.

  • Serious emotional disturbance means a diagnosable mental, behavioral, or emotional disorder affecting a minor that exists or has existed during the past year for a period of time sufficient to meet diagnostic criteria specified in the most recent Diagnostic and Statistical Manual of Mental Disorders published by the American Psychiatric Association and approved by the department and that has resulted in functional impairment that substantially interferes with or limits the minor's role or functioning in family, school, or community activities. The following disorders are included only if they occur in conjunction with another diagnosable serious emotional disturbance:

  • 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.

  • Infectious agent means that term as defined in R 325.9031 of the Michigan administrative code.

  • Noxious weeds means weeds that are difficult to control effectively, such as Johnson Grass, Kudzu, and multiflora rose.