CRED SMPC 2024

17/09/2024

Always remember…

The draft label is continually evolving:

Internal Factors ● New Data (updates to CCDS) ● Changes in internal corporate requirements

External Factors ● Changes in regulatory environment ● Changes in the commercial environment (generics, competitors etc.)

The Organisation for Professionals in Regulatory Affairs

33

Pitfalls during the endgame

• You have produced the labelling fallbacks…

• You have negotiated your labelling with the Rapp / Co-Rapp / RMS / CMS / National Agency etc

You’re ready to relax…

•

The Organisation for Professionals in Regulatory Affairs

34