CRED Getting the CMC Dossier Right 2024

28/08/2024

Data Requirements and Practical Guidance for Drug Substance Development

Olivier Dirat, Senior Director

Global Regulatory Sciences, CMC Advisory Office, Pfizer, Sandwich, UK

The Organisation for Professionals in Regulatory Affairs

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Outline

• Challenges of drug development and the role of the regulatory team member

• Phase appropriate submission content

Supporting ICH guidelines

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• ICH Q11: Traditional vs enhanced and control strategy

Starting materials

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N -Nitrosamines

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Stability

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• Drug Substance Global Registration and Lifecycle Considerations

The Organisation for Professionals in Regulatory Affairs

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