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.)
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.
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.
Examples of Special Situation in a sentence
S.L. 1353 Supplemental Nutrition Assistance Program Special Situation HouseholdsChapter 365Rev.
Révolution ou mutation ?, Paris, Libre & solidaire, 2018 (1978), pp.
Special Situation: If a large boulder or log is located on an increment point and the obstruction is below bankfull elevation, collect the point on top of the obstruction.
Special Situation (‘SS’) report means a report of the use of an ASTELLAS product covered by this CONTRACT outside of the approved label, lack of efficacy, exposure during pregnancy or breastfeeding, occupational exposure, overdose, abuse, misuse, suspected transmission of an infectious agent, or medication errors which may or may not be reported with an Adverse Event.
S.L. 1353 Supplemental Nutrition Assistance Program Special Situation Households Chapter 365Rev.
More Definitions of Special Situation
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: • Overdose of relevant product,• Pregnancy exposure (maternal and paternal),• Exposure to the relevant product from breastfeeding,• Suspected abuse / misuse of the relevant product,• Inadvertent or accidental exposure to the relevant product (including occu- pational exposure),• Any failure of expected pharmacological or medical device action (i.e. lack of effect) of the relevant product,• Unexpected therapeutic or clinical benefit from use of the relevant product,• Medication error involving relevant product with or without patient / consumer exposure to the relevant product, (e.g. name confusion) OR that caused an unintended effect or could cause an intended effect,• Suspected transmission of an infectious agent via relevant product,• Expired drug use and falsified medicine,• Off-label use - situations where relevant product is intentionally used for a medical purpose not in accordance with the authorised product information
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,
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.
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.
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.
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), CERTAIN MATERIAL (INDICATED BY AN ASTERISK) HAS BEEN OMITTED FROM THIS DOCUMENT PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT. THE OMITTED MATERIAL HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. • 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.