Module 6

04/10/2024

2. Risk Control (2)

The Organisation for Professionals in Regulatory Affairs

Issues Management or Managed by Issues?

21

2. Risk Control (3) Risk Reduction Ex 1

Non-compliance with Promotional requirements presents a Risk to the organisation

• Breaches could have several negative outcomes e.g.

• Compromise patient safety

• Damage Company reputation and Brand with

Customers

•

Patients

•

Regulators

•

• Restrict ability to attract and retain top talent

• Result in prosecution, fines, sanctions and reprimands

• Lead to “pre - vetting” in the UK

Impact share price

•

The Organisation for Professionals in Regulatory Affairs

Issues Management or Managed by Issues?

22

11