CRED 8 Presentations

01/07/2024

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

1

Learning Outcomes

• Scheduling the submission • Access to procedures • Commercial considerations • Tradename issues • Pre-submission meetings • Timelines • Conditional approvals/exceptional circumstance

The Organisation for Professionals in Regulatory Affairs

2