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Testing of biological medicines

V1.0 December 2015

22 December 2015

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Example of risk assessment tool

Example: biological medicine risk assessment tool

This image represents a screenshot of the report page of TGA's biological medicine risk assessment tool.

It displays the sponsor name, each product which was entered (including its ARTG number).

Below this, it displays scores for both consequence and likelihood of risks, and the total score which results from multiplying the consequence and likelihood scores.

Where this total score sits within a range determines the risk level of a product for the purpose of testing.

The report also displays a calculated risk rating; calculated risk group; a description field for the review of the risk assessment; and a final risk group rating.

Screenshot described in text above

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