CRED SMPC 2024

18/09/2024

Format

Group discussion

The Organisation for Professionals in Regulatory Affairs

3

Your Scenario

Your company has obtained an EU marketing authorization (Centralised procedure) for an injectable. The product is supplied in packs of 10 pre-filled syringes and is supplied to pharmacies and family doctors for injection by a healthcare professional. The product strategy is to introduce self-administration into the label. Patients will inject once every six months and the company strategy is to introduce a single-syringe presentation for patients to use. The product team needs you to design the new pack and populate it with the required regulatory content. You will also have to consider other stakeholders, including commercial, package engineering and supply chain teams with whom you need to collaborate and discuss the feasibility and desirability of your proposed design.

The Organisation for Professionals in Regulatory Affairs

4