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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