CRED 8 Presentations

01/07/2024

Preparing and Applying for a Centralised Procedure (Details in back-ups)

The Organisation for Professionals in Regulatory Affairs

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• Familiarize yourself with the EMA Pre-Submission Guidance • Make sure you understand timelines and deadlines…and where there may be flexibility (some timelines advisory) • Check regularly for updates! • Make sure you have an EMA Account and make sure you have back-ups (and don’t forget IRIS for Orphan products) • This can take longer than you think – use the helpdesk if needed • Speak to colleagues/peers who have done this before • Be prepared for some bureaucracy…and some “Interesting” forms to fill Before you submit

The Organisation for Professionals in Regulatory Affairs

4