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Overdose refers to the administration of a quantity of a medicinal product given per administration or cumulatively, which is above the maximum recommended dose according to the authorised product information.
Overdose refers to the administration of a quantity of a medicinal product given per administration or cumulatively, which is above the maximum recommended dose according to the authorised product information.
True
Misuse and abuse of a medicinal product have the same definition.
Misuse and abuse of a medicinal product have the same definition.
False
Primary sources' details, including their qualifications, should not be provided in the ICSR if they report information on the same case.
Primary sources' details, including their qualifications, should not be provided in the ICSR if they report information on the same case.
False
Occupational exposure refers to exposure to a medicinal product during the manufacturing process before its release as finished product.
Occupational exposure refers to exposure to a medicinal product during the manufacturing process before its release as finished product.
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Misuse of a medicinal product refers to situations where it is intentionally and inappropriately used not in accordance with the terms of the marketing authorisation.
Misuse of a medicinal product refers to situations where it is intentionally and inappropriately used not in accordance with the terms of the marketing authorisation.
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Falsified medicinal product definition includes unintentional quality defects.
Falsified medicinal product definition includes unintentional quality defects.
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What is the definition of a serious adverse reaction according to ICH-E2A?
What is the definition of a serious adverse reaction according to ICH-E2A?
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What is the difference between a life-threatening reaction and a reaction that hypothetically might have caused death if more severe?
What is the difference between a life-threatening reaction and a reaction that hypothetically might have caused death if more severe?
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What is the purpose of the IME list based on the Medical Dictionary for Regulatory Activities (MedDRA)?
What is the purpose of the IME list based on the Medical Dictionary for Regulatory Activities (MedDRA)?
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