CRED 8 Presentations

01/07/2024

Recommend to Tier Questions – An Example!

Tier 1 Critical Issues

Tier 2 Clarification or requested new presentation of existing data

Major objections (plus some other concerns) High impact on overall strategy and/or approvability of the dossier

•

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Tier 3 Administrative • Low impact on overall strategy and/or approvability of dossier • Usually handled in regulatory only

• Minimal to moderate impact on overall

strategy and/or approval dossier (“other concerns”)

Prioritise questions to ensure correct stakeholders/seniority/decision makers involved, and to focus on critical issues for clarification meeting

The Organisation for Professionals in Regulatory Affairs

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Submit your response…and prepare to do it all again!!!

• Submit your responses per EMA deadline • At the next stage of the procedure – you will again receive preliminary assessment reports and the formal CHMP “List of Outstanding Issues” • Major Objections at this stage may be a problem – prepare for potential Oral Explanation and/or Scientific Advisory Group

The Organisation for Professionals in Regulatory Affairs

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