CRED SMPC 2024

17/09/2024

Role of Regulatory Affairs and Other Functions

• Input and review of final drafts according to internal process and roles and responsibilities

• Final label text provided to commercial and packaging management to create mock-ups for submission

• Final mock-up review and approve according to internal processes

• Coordination of the preparation of the MAA including labelling as part of Module 1

• Provide timings pre and post MAA submission to stakeholders

The Organisation for Professionals in Regulatory Affairs

23

Thank you!

The Organisation for Professionals in Regulatory Affairs

24