Human Safety Information definition

Human Safety Information means any information relating to:
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Human Safety Information or “HSI” shall mean information relating to human health and/or wellbeing following exposure to the product such as Adverse Event information, and including:
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Human Safety Information. (HSI) means any information relating to human health and/or wellbeing following exposure to GSK products, including Adverse Event information. Adverse Event (AE) means any untoward medical occurrence in a patient, clinical investigation subject or consumer, and is temporally associated with the use of a GSK Product, whether or not considered related to the product. Human Safety Information and related Adverse Events (“HSI/AE”) can include: any unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated); failure to produce expected benefits (i.e. lack of efficacy); reports of off-label use; reports of medication errors or misuse, including drug overdose, whether accidental or intentional; reports of drug abuse or effects of drug withdrawal; reports of occupational exposure; reports of patients taking GSK Products while pregnant or breastfeeding; reports of paternal exposure to a GSK Product before and during pregnancy; transmission of an infectious agent via a medicinal product; safety information received as part of a product quality complaint; reports of drug interaction; unexpected therapeutic benefits – an unexpected improvement in a concurrent condition other than the one being treated;
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Examples of Human Safety Information in a sentence

  • Therefore, the Parties require a framework for management of Human Safety Information.

  • The framework includes, but is not limited to: · Safety reviews of Products to evaluate emergent safety data · Creation of appropriate committees and safety departments to proactively address human safety throughout Product development · Reporting of Human Safety Information to safety departments in a timely fashion.

  • The framework includes, but is not limited to: • Safety reviews of Products to evaluate emergent safety data • Creation of appropriate committees and safety departments to proactively address human safety throughout Product development • Reporting of Human Safety Information to safety departments in a timely fashion.

  • For the Purchaser’s consumer healthcare products, the Supplier will report Human Safety Information, quality complaints, or suspected counterfeits to GSK Australia Product Information on 1800 028 533 or +00 0 0000 0000 within 24 hours of initial awareness.

  • For the Purchaser’s consumer healthcare products, the Supplier will report Human Safety Information, quality complaints, or suspected counterfeits to GSK on 0800 540 144 or +00 0 0000 0000 within 24 hours of initial awareness.

  • For the Purchaser’s pharmaceutical products, the Supplier will report Human Safety Information, quality complaints, or suspected counterfeits to GSK on 0800 808 500 or +00 0 0000 0000 within 24 hours of initial awareness.

  • All Haleon employees are provided with a mandatory induction training and an annual mandatory refresher on Haleon Code of Conduct which includes Haleon Global Quality Policy and Haleon Policy for Collecting information from Consumers (reporting of Human Safety Information including adverse events, medical information, and product quality complaints).

  • During the contract duration if the Third Party or any of its sub-contractors becomes aware of Human Safety Information (HSI), including Adverse Events (“AE”) (together referred as HSI/AE) (whether the information relates to the GSK Product by reference to its generic name or by reference to its trade xxxx) it shall forward such information to GSK.

  • For the Purchaser’s pharmaceutical products, the Supplier will report Human Safety Information, quality complaints, or suspected counterfeits to GSK Australia Medical Information on 1800 033 109 or +61 3 9721 4323 within 24 hours of initial awareness.

  • During the contract duration if the Third Party or any of its sub-contractors becomes aware of Human Safety Information (HSI), including Adverse Events (“AE”) (together referred as HSI/AE)(whether the information relates to the GSK Product by reference to its generic name or by reference to its trade xxxx) it shall forward such information to GSK.


More Definitions of Human Safety Information

Human Safety Information means any information relating to: (a) the death, serious injury or illness of a person that may have been caused by the use or misuse of the Purchaser’s product (a serious injury or illness includes any acute physical injury or illness requiring medical or surgical treatment by, or under the supervision of, a qualified doctor or nurse); or
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Human Safety Information means information relating to human health and/or wellbeing arising following exposure of humans to a Medicinal Product including: • Adverse Events • failure to produce expected benefits (i.e. lack of therapeutic efficacy); • reports of Medication Errors or Misuse, including drug Overdose, whether accidental or intentional; • reports of drug Abuse or effects of drug withdrawal; • reports of Occupational Exposure; • reports of patients taking a Product whilst pregnant (Pregnancy Report) or breastfeeding; • reports of drug interaction; • reports of paternal exposure to a Product; Suspected transmission of an infectious agent via a Product; • information received as part of a product complaint • unexpected therapeutic benefits – an unexpected improvement in a concurrent condition other than the one being treated and • reports of Off-label Use
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Human Safety Information means any information relating to: (a) the death, serious injury or illness of a person that may have been caused by the use or misuse of the Purchaser’s product (a serious injury or illness includes any acute physical injury or illness requiring medical or surgical treatment by, or under the supervision of, a qualified doctor or nurse); or (b) human health and/or wellbeing arising following exposure of humans to the Purchaser’s products such as Adverse Event information, including: any unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated); reports of patients taking drugs whilst pregnant or breastfeeding; drug abuse or drug withdrawal; medication errors or misuse, including drug overdose, whether accidental or intentional; information received as part of product complaints; failure to produce expected benefits (i.e. lack of efficacy); reports of occupational exposure; reports of drug interaction; reports of paternal exposure to a GSK Product; and information regarding unexpected therapeutic benefits such as unexpected improvement in a concurrent condition other than the one being treated;
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Related to Human Safety Information

  • Patient Information means information (however recorded) which—

  • Third Party Information means confidential or proprietary information subject to a duty on the Company’s and its affiliates’ part to maintain the confidentiality of such information and to use it only for certain limited purposes.

  • Contractor information system means an information system belonging to, or operated by or for, the Contractor.

  • Transparency Information means the content of this Contract in its entirety, including from time to time agreed changes to the Contract, and details of any payments made by the Authority to the Contractor under the Contract;

  • Biometric information means any information, regardless of how it is captured, converted, stored, or shared, based on an individual’s biometric identifier used to identify an individual. Biometric information does not include information derived from items or procedures excluded under the definition of biometric identifiers.

  • Client Information means any data, information, software or other materials that you provide to Red Hat under the Agreement.

  • Company Information As defined in Section 4(a)(i).

  • Business Confidential Information has the meaning set forth in Section 5.04(a).

  • Appendix Information means the information which must be provided for the selected modules as set out in the Appendix of the Approved EU SCCs (other than the Parties), and which for this Addendum is set out in:

  • Genetic information means, with respect to any individual, information about such individual’s genetic tests, the genetic tests of family members of such individual, and the manifestation of a disease or disorder in family members of such individual. Such term includes, with respect to any individual, any request for, or receipt of, genetic services, or participation in clinical research which includes genetic services, by such individual or any family member of such individual. Any reference to genetic information concerning an individual or family member of an individual who is a pregnant woman, includes genetic information of any fetus carried by such pregnant woman, or with respect to an individual or family member utilizing reproductive technology, includes genetic information of any embryo legally held by an individual or family member. The term “genetic information” does not include information about the sex or age of any individual.

  • Employee Liability Information means the information which a transferor is obliged to notify to a transferee pursuant to Regulation 11(2) of TUPE regarding any person employed by him who is assigned to the organised grouping of resources or employees which is the subject of a relevant transfer and also such employees as fall within Regulation 11(4) of TUPE;

  • DXC Sensitive Information means DXC Confidential Information, Intellectual Property, PHI, DXC Customer data, and Personal Information.

  • Patient identifying information means an insured's address, telephone number, facsimile number, electronic mail address, photograph or likeness, employer, employment status, social security number, or any other information that is likely to lead to the identification of the insured.

  • Customer information systems means any methods used to access, collect, store, use, transmit, protect, or dispose of customer in- formation.

  • Authority's Confidential Information means all Personal Data and any information, however it is conveyed, that relates to the business, affairs, developments, trade secrets, know-how, personnel, and suppliers of the Authority, including all IPRs, together with all information derived from any of the above, and any other information clearly designated as being confidential (whether or not it is marked "confidential") or which ought reasonably be considered to be confidential;

  • Other Confidential Consumer Information The Contractor agrees to comply with the requirements of AHS Rule No. 08-048 concerning access to information. The Contractor agrees to comply with any applicable Vermont State Statute, including but not limited to 12 VSA §1612 and any applicable Board of Health confidentiality regulations. The Contractor shall ensure that all of its employees and subcontractors performing services under this agreement understand the sensitive nature of the information that they may have access to and sign an affirmation of understanding regarding the information’s confidential and non- public nature.

  • Covered contractor information system means an information system that is owned or operated by a contractor that processes, stores, or transmits Federal contract information.

  • Suitability information means information that is reasonably appropriate to determine the suitability of a recommendation, including the following:

  • Program Information has the meaning set forth in Section 14.8.

  • Confidential System Information means any communication or record (whether oral, written, electronically stored or transmitted, or in any other form) provided to or made available to Grantee; or that Grantee may create, receive, maintain, use, disclose or have access to on behalf of HHSC or through performance of the Project, which is not designated as Confidential Information in a Data Use Agreement.

  • Electronic information means information presented or provided in an electronic format.

  • Information Technology Systems means all information technology systems, Software, computers, workstations, databases, routers, hubs, switches, networks and other information technology equipment used or held for use in, or otherwise relating to, the Business.

  • Citizens Confidential Information means all information, data, and documentation, whether marked as confidential or not, disclosed to Vendor in the course of this Agreement that is either: (a) Protected under any applicable state or federal law (including Chapter 119, Florida Statutes; Sections 501.171, and 627.351(6), Florida Statutes; Chapter 69O-128, Florida Administrative Code; and, 15 U.S.C. § 6801 et seq.); (b) private information concerning Citizens’ employees or policyholders (including social security numbers, personal health information, personal credit information, banking information, drivers’ license numbers, personal email addresses, personal phone numbers, and home addresses); or, (c) related to any Citizens’ manuals, lists, operating and other systems or programs, business practices or procedures, insurance policies, claimants or claims, or any business, governmental, and regulatory matters affecting Citizens. “Citizens Confidential Information” does not include any information, data or documentation that: (a) is publicly available through no fault of Vendor or Vendor Staff; or, (b) Vendor developed independently without relying in any way on Citizens Confidential Information.

  • Electronic Protected Health Information means Protected Health Information that is maintained in or transmitted by electronic media.

  • information folder means the complete folder, including the information document, file, data, drawings, photographs, and so on, supplied by the applicant, it being permissible to supply the information folder in the form of an electronic file;

  • Confidential commercial information means records provided to the govern- ment by a submitter that arguably contain material exempt from release under Exemption 4 of the Freedom of Information Act, 5 U.S.C. 552(b)(4), be- cause disclosure could reasonably be expected to cause substantial competi- tive harm.