Module 6

04/10/2024

1. Risk Assessment – Analysis

• The process of Risk Analysis (Sourcing) will lead to an understanding of each “High Risk” Issue.

Analyse each risk

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Brainstorming

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Internet/Media

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• Results of scientific research (Internal/External)

• Reporting procedures (ADEs, PMS, Signal detection)

• Contacts from external experts

• Contacts by interested organisations

Reports from colleagues

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Understand each risk

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Why is it a risk?

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• Are there common risk sources?

• People, events, supply chain?

The Organisation for Professionals in Regulatory Affairs

Issues Management or Managed by Issues?

17

1. Risk Assessment – Analysis

In relation to a particular Risk, there are certain basic strategies begin to Evaluate • Responding to Risk (Consider the 4 T ’S) • T ake the Risk (where no further cost-effective controls are possible) • T erminate the activity • T ransfer the risk to another party • T reat the risk by instituting appropriate business controls – What the Risk (Location, Finance, IT, ….)

The Organisation for Professionals in Regulatory Affairs

Issues Management or Managed by Issues?

18

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