CRED 8 Presentations

01/07/2024

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

“Letter of Intent” &

Rapporteur Assignment

EMA Pre Submission Interaction

Submission Preparation

The Organisation for Professionals in Regulatory Affairs

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EMA Pre-submission Interactions

6-7 Months prior to Submission

• These are the best opportunity to obtain procedural advice before submission • …and provide the chance to meet the EMA Product Lead, your main contact throughout the procedure (another critical relationship) • Use interaction to “de-risk” and agree content of application • Ask the right questions to ensure a valid submission and avoid issues during the procedure • Complete an MAA Pre-submission Interactions form, summarisingissues to be discussed • Include background information (briefing document) and supporting annexes e.g. Overview of development program, draft RMP, draft SmPC, draft protocols etc. • Written answers given within 3 weeks; meetings held case-by-case • If meeting, prepare supporting presentation for meeting and provide meeting minutes to Agency after

The Organisation for Professionals in Regulatory Affairs

Abbreviations: RMP = Risk Management Plan, SmPC = Summary of Product Characteristics

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