Module 6

03/10/2024

GVP V: Risk management systems – objectives

• At the time of authorisation, information on the safety of a medicine is limited. As not all actual or potential risks are identified, many will only be identified post authorisation.

• Purpose of risk identification and characterisation is to allow for risk minimisation or mitigation where possible.

• Risk management - 3 key stages :

1. Characterisation of medicine safety profile including what is known and not known

2. Planning of PV activities to characterise risks and identify new risks and increase the knowledge in general about the safety profile of the medicine

3. Planning and implementation of risk minimisation and assessment of the effectiveness of these activities

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Risk management is an iterative process

Improvement

Identify Detect

Risk Assessment & Planning

Monitor Evaluate

Analyse

Communicate

The domain of risk minimisation

Plan

Control

Implementation/

Mitigation

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