CRED Understanding Clinical Development 2024

08/10/2024

Validation and review

Validation

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• Paediatric Coordinator (PC) validates the application

• Changes may be requested with short turnaround time

Review

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• 3 principal reviewers: PC, Rapporteur and Peer Reviewer

• Their comments are included in the Summary Reports

• All PDCO members vote on the outcome, but they are strongly led by the principal reviewer comments

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Formulation aspects

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• Do not underestimate the importance of this

• The key phrase is “age - appropriate formulation” (AAF)

• Can tablets / capsules be taken?

• If so, should they be physically smaller?

• Is something else needed?

Oral liquid?

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Microgranules?

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Injectable presentation?

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