CRED NPM

05/11/2024

Safety & risk

Use current Risk Management Plan (RMP) to identify risk and where RMP may need to be amended

Consider if post authorisation evaluation would contribute to safe use

Consider if risk management materials will be needed

Identify any possible concerns

The Organisation for Professionals in Regulatory Affairs

9

Candidate benefits

Widened access

Consumer need

Public health benefit

Improved clinical outcome

National healthcare saving

The Organisation for Professionals in Regulatory Affairs

10

5