Module 18 2021

08/02/2021

Pre-amble

Toxicological hazard • Nature of toxic effects • Dosages at which they occur • The No Observed Adverse Effect Level (NOAEL)

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Toxicological risk • Quantitative assessment of nature of effects in context of amount to which subject is exposed and route of exposure

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The Organisation for Professionals in Regulatory Affairs

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Pre-amble

• Biological/nonclinical assessment is not a tick-box process

• Rather, a qualified individual developing an evaluation programme based on the specifics of the device/drug is required

• Purpose: to assure safety for patient or user

The Organisation for Professionals in Regulatory Affairs

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