CRED Getting the CMC Dossier Right 2024

28/08/2024

Role of Regulatory Team Member [1]

Provide phase appropriate regulatory guidance to the team ● Outline requirements for each phase of development ● Proactively plan activities to support later phases and registration ● Develop and prosecute program appropriate regulatory strategies ● Outline regulatory risks and identify mitigation strategies ● Update the team on recent regulatory developments and outline regional requirements

The Organisation for Professionals in Regulatory Affairs

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Typical deliverables during clinical phases ● Ensure that development activities support the phase appropriate requirements for IND/IMPD submissions ● IMPD / IND submissions and their updates ● Consider agency interactions ● Plan for the registration – Starting material identification – Impurity control strategy (including nitrosamines) – Development of the overall control strategy – Outline regional requirements – Plan for the generation of the stability data Role of Regulatory Team Member [2]

The Organisation for Professionals in Regulatory Affairs

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