CRED 8 Presentations

01/07/2024

A word on the Rapporteurs

• You cannot choose your Rapporteurs (but can you influence the choice?) • Rapporteurs are the “Figureheads” of their Assessment Teams • The Rapporteurs can be very influential in the success of your filing • They will not always agree with each other

• …and if they don’t agree with you, you can still be successful • Building a relationship with the Rapporteurs is crucial

• Although not mandatory, Pre-Submission meetings can be vital to the success of your application (particularly if you plan to request Accelerated Assessment) – use them wisely! • Orient the Rapporteurs to application content, particularly any potential issues/challenges – don’t shy away from tough discussions

The Organisation for Professionals in Regulatory Affairs

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What to expect pre-submission T minus 18 months T minus 7 months T minus 6 months T minus 3 months

T minus 2 months

Submission

Eligibility Request (deadlines per EMA website, can be submitted with Letter of Intent)

Reconfirm Planned Submission Date

Q: When to meet with the Rapporteurs? A: At a point where any feedback can be incorporated into your dossier

“Letter of Intent” &

Rapporteur Assignment

EMA Pre Submission Meeting

Submission Preparation

The Organisation for Professionals in Regulatory Affairs

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