CRED ERP 25

01/07/2025

Finalising your European Regulatory Strategy

Jayne Hunt, Arriello s.r.o.

The Organisation for Professionals in Regulatory Affairs The Organisation for

Professionals in Regulatory Affairs

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Learning Outcomes

Scheduling the submission

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Access to procedures

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Commercial considerations

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Tradename issues

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Pre-submission meetings

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Timelines

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• Conditional approvals/exceptional circumstance

The Organisation for Professionals in Regulatory Affairs

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1