Module 6

04/10/2024

The Principles of Risk Management can be applied to any ISSUE

The Organisation for Professionals in Regulatory Affairs

Issues Management or Managed by Issues?

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1. Risk Assessment – Identification

• To identify Risks, the nature of the business must be fully understood and objectives clarified.

• What is the culture and operating style within, and around the business?

Risk Taking?

•

Cautious?

•

• What are the internal constraints which limit freedom of action or choice?

Time, Money, Manpower

•

• What expectations have been set?

• What promises have been made?

• What must be delivered?

• What are the external constraints?

Laws

•

Regulations

•

• Mandatory Standards (GMP, GDP, GCP GPVgP)

The Organisation for Professionals in Regulatory Affairs

Issues Management or Managed by Issues?

14

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