Module 5 Presentations

16/07/2024

Medical Devices – Totally different scenario and not covered here…..

FDA – ISO 10993-1

The Organisation for Professionals in Regulatory Affairs

Module 5 Lecture 3 – Nonclinical safety assessment

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Hazards and Risks

Identify Hazard In genetic toxicology, safety pharmacology, reproductive & general toxicology studies

Hazard identification

Understand Hazard Severity, reversibility, dose

Hazard characterisation

response, species concordance, mechanism (rare), clinical markers

Risk characterisation

Assess Risks Weight of evidence from identity & characterisation of events. Harm to humans?

The Organisation for Professionals in Regulatory Affairs

Module 5 Lecture 3 – Nonclinical safety assessment

8

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