CRED SMPC 2024

17/09/2024

Fall back positions

How

• Timelines for labelling discussions can be very short • Negotiation options (fallback positions) are valuable to plan for contingencies if there are differences in interpretation • Important to have strategy in place and endorsed up front (Labelling team meetings preparation) • Fallback should be reasonable compromise – a win-win between you and the agency • Worst case fallback – minimum threshold if not achieved would lead to withdrawal

The Organisation for Professionals in Regulatory Affairs

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Where do your labelling team meetings take place?

Where

• Likely online - geographic spread of experts

• Consider time zones and different public holidays

• Make sure you have an agenda and your materials are clear

• Provide document in advance for review/comments

• Consider smaller groups focusing on specific sections if needed (round tables at kick-off and review stage)

• Without visual cues/body language, check with team that there is good understanding

The Organisation for Professionals in Regulatory Affairs

32