CRED SMPC 2024

17/09/2024

Conclusion

An optimum label is one that is fit for purpose: ● Summarises the scientific data ● Summarises the agreed position with regulatory authorities based on the data ● Informs prescribers ● Enables marketing of the compound

The earlier a label can be drafted the better the chance of achieving the optimum label

The Organisation for Professionals in Regulatory Affairs

43

Thank you for listening

Questions?

The Organisation for Professionals in Regulatory Affairs

44