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:

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;

Examples of Human Safety Information in a sentence

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.
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.
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 +▇▇ ▇ ▇▇▇▇ ▇▇▇▇ 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 +▇▇ ▇ ▇▇▇▇ ▇▇▇▇ 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 +▇▇ ▇ ▇▇▇▇ ▇▇▇▇ 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 ▇▇▇▇) it shall forward such information to GSK.
Should the Annual Net Revenue, as may be adjusted in accordance with the foregoing, equal at least 85% of the required minimum for the fiscal year ending July 31, 1997, there shall be no reduction in the total maximum number of shares that may be earned, except the Annual Minimum Net Revenue for fiscal year 1998 shall be increased by the amount of the total shortfall for both years.
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 ▇▇▇▇) it shall forward such information to GSK.
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 ▇▇▇▇) it shall forward such information to VIIV.

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 (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;

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