CRED SMPC 2024

17/09/2024

Labelling teams: Running the Meetings

How

• SOPs – ensure team understands the process • Help your team understand the labelling requirements •

How does the data need to be presented to meet the regulatory requirements?

• Timetable – schedule well ahead to ensure good attendance • Have a plan – which sections, when? • Minutes & actions - deadlines • Review/Approvals – does a higher-level governance body need to approve/endorse? • Presenting the sections: • Guidelines • Company Core Data Sheet (CCDS) • Text (SMEs/labelling may draft – people often review better than they author) • Options A or B • Back up plans if X not accepted, keep Y in background

The Organisation for Professionals in Regulatory Affairs

29

Difficulties Completing a Draft Label

How

• Wording needs to be flexible enough for differences in local country healthcare systems

• Ensure that wording is translatable

Use affiliates to help review

•

• Easier to manage this up front rather than during the HA review

The Organisation for Professionals in Regulatory Affairs

30