Special Situation definition

Special Situation. An occasion or incident for which an employee desires time off but for which the employee cannot be granted time off with pay (i.e. vacation, sick leave, compensatory time off with pay, etc.)
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Special Situation means any outcomes of pregnancies of patients exposed to product, AE during breastfeeding, data on use of product in children, lack of efficacy (effect), transmission of an infectious disease with product, overdose, misuse, or abuse, medication errors or AE in compassionate use/named patient use. For reporting purposes, Medical Imaging considers Special Situations to be AEs that must be reported within 24 hours.
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Special Situation. Occurrences or reports that may not contain an adverse event, which must still be collected and reported in order to meet regulatory safety reporting requirements and J&J Company policies: • Overdose of Product, • Pregnancy exposure (maternal and paternal), • Exposure to the Product from breastfeeding, • Suspected abuse/misuse of the Product, • Inadvertent or accidental exposure to the Product (including occupational exposure), • Any failure of expected pharmacological or medical device action (i.e. lack of effect) of the Product, • Unexpected therapeutic or clinical benefit from use of the Product, • Medication error involving the Product with or without patient/consumer exposure to the Product, (e.g. name confusion) OR that caused an unintended effect or could cause an intended effect (e.g. adult medicine given to a young child), • Suspected transmission of an infectious agent via Product, • Expired drug use and falsified medicine • Off-label use – situations where the Product is intentionally used for a medical purpose not in accordance with the authorized product information Off-label use without an associated AE, Special Situation, UE, ADE or AEPQC should be collected only when it is specifically and voluntarily brought to the attention of the Exagen in an unsolicited manner by a reporter e.g., Health Care Professional or data obtained from databases where off-label use may be systematically collected (e.g., reimbursement database in US), and in accordance with local procedure in compliance with local laws and regulations. Follow-up of off-label use is not required.
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Examples of Special Situation in a sentence

  • Institution and Investigator will report all serious adverse events, Special Situation Reports (defined below), and other safety concerns as specified in the Protocol and in accordance with applicable laws, rules and regulations, including, but not limited to ICH-E2A and the European Union Directive 2001/20/EC.

  • Notice shall be deemed given when so delivered personally or, if sent by private national courier service, on the next business day after delivery to the courier, or, if mailed, two business days after the date of mailing, as follows: Asia Special Situation Acquisition Corp.

  • Except as otherwise agreed to by the Company, and notwithstanding termination of this Agreement, the terms and provisions of the Confidentiality Agreement, dated as of November 11, 2005 (the “Confidentiality Agreement”), between AG Special Situation Corporation and Eureka Capital Markets, LLC (to which the Company is a third party beneficiary) shall apply to all information furnished to any Acquisition Corp.

  • Any consumer reports with accompanying medical documentation supporting the AEs or Special Situation reports will be considered as “medically confirmed” and processed accordingly.

  • To an Investor, to: [Name of Investor] c/o Asia Special Situation Acquisition Corp.

  • For such reports the following information must be actively sought: An identifiable report source (name, address, qualification); An identifiable patient (e.g. initials, date of birth, age group, age or gender); A suspect medicinal product; and An AE or Special Situation.

  • GLOBAL SAFETY DATABASE NORGINE is responsible for establishing and maintaining the Global Safety Database containing all AEs and relevant Special Situation reports for the Product that will be used for safety monitoring activities, and responses to safety queries from Regulatory Authorities for the Product until the termination of this Agreement (or, as applicable, until the obligations intended to survive termination of this Agreement have been fulfilled).

  • Special Situation Thirty (30) years of service to the Garden City School System.

  • If follow-up information is received after reporting a Serious AE, AE, Product Quality Complaint or Special Situation, Member also must report such information.

  • Provider and Investigator will report all serious adverse events, Special Situation Reports (defined below), and other safety concerns as specified in the Protocol and in accordance with applicable laws, rules and regulations, including, but not limited to ICH-E2A and the European Union Directive 2001/20/EC.


More Definitions of Special Situation

Special Situation means any outcomes of pregnancies in patients exposed to the Product, any Adverse Event during breastfeeding, data on use of the Product in children, lack of efficacy (effect), transmission of an infectious disease with the Product, overdose, misuse, or abuse, medication errors or Adverse Event in compassionate use/named patient use of the Product.
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Special Situation means the board of directors of BHMF REIT has (i) adopted a resolution to begin (a) the process of Listing, (b) a Merger with a person that it not an Affiliate of BHMF REIT, or (c) a Disposition, and (ii) determined that it is in the best interest of BHMF REIT to terminate the Partnership.
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Special Situation means a condition under which the department may provide direct control services as a last resort, as requested by the applicant, because in its evaluation an imminent vector hazard exists. [Eff. 9/18/81; am and comp 8/10/00] (Auth: HRS §§321-9,
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Special Situation means occurrences or reports that may not contain an adverse event, which must still be collected and reported in order to meet regulatory safety reporting re- quirements:
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Special Situation. Occurrences or reports that may not contain an adverse event, which must still be collected and reported in order to meet regulatory safety reporting requirements and Janssen policies: • Overdose of Product, • Pregnancy exposure (maternal and paternal), • Exposure to the Product from breastfeeding, • Suspected abuse/misuse of the Product, • Inadvertent or accidental exposure to the Product (including occupational exposure), • Any failure of expected pharmacological action (i.e. lack of effect) of the Product, • Unexpected therapeutic or clinical benefit from use of the Product, • Medication error (includes potential, intercepted or actual) involving the Product with or without patient/consumer exposure to the Product, (e.g. name confusion) OR that caused an unintended effect or could cause an intended effect (e.g. adult medicine given to a young child), • Suspected transmission of an infectious agent via Product, • Expired drug use and falsified medicine, • Off-label use - situations where the Product is intentionally used for a medical purpose not in accordance with the authorized product information. Off-label use without an associated AE, Special Situation, UE or AEPQC should be collected only when it is specifically and voluntarily brought to the attention of a Company Employee in an unsolicited manner by a reporter e.g., Health Care Professional or data obtained from databases where off-label use may be systematically collected (e.g., reimbursement database in US), and in accordance with local procedure in compliance with local laws and regulations. Follow-up of off-label use is not required.
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Related to Special Situation

  • Asset Management is a principle/practice that includes planning processes, approaches, plans, or related documents that support an integrated lifecycle approach to the effective stewardship of infrastructure assets to maximize benefits and effectively manage risk.

  • Asset Management Company means an asset Management Company as defined in the Rules and Regulations.

  • Asset Management Plan means a strategic document that states how a group of assets are to be managed over a period of time. The plan describes the characteristics and condition of infrastructure assets, the levels of service expected from them, planned actions to ensure the assets are providing the expected level of service, and financing strategies to implement the planned actions. The plan may use any appropriate format, as long as it includes the information and analysis required to be in a plan as described in Ontario’s Building Together: Guide for Asset Management Plans.

  • GS shall have the meaning assigned to such term in the preamble to this Agreement.

  • Management Group means at any time, the Chairman of the board of directors, the Chief Executive Officer, the President, any Managing Director, Executive Vice President, Senior Vice President or Vice President, any Treasurer and any Secretary of Holdings or other executive officer of Holdings or any Subsidiary of Holdings at such time.