CRED 8 Presentations

01/07/2024

Scheduling your submission (2)

• Build in time for eCTD compilation and publishing • Need to balance business/ marketing strategy vs. strategic considerations & technical risks • Premature submission vs. delayed filing • Build-in quality from beginning • Internal resource to respond to validations/ scientific questions

The Organisation for Professionals in Regulatory Affairs

5

Scheduling your submission (3)

• Be honest and transparent

• Realistic vs. stretch goals • Best guess vs. worst case • Filing dates vs. approval dates • Confirm centralised eligibility (if needed) • Submit ‘Intent to File Notification’ or book the RMS ‘slot’ (decentralised procedure) (common request form)

The Organisation for Professionals in Regulatory Affairs

6