CRED Getting the CMC Dossier Right 2024

05/09/2024

Data Requirements and Practical Guidance for Medicinal Product Development

Sharon Page

Director, CMC

Pfizer R&D UK Ltd

The Organisation for Professionals in Regulatory Affairs The Organisation for

Professionals i Regulatory Affairs

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Learning Outcomes

• Issues faced at different phases of development

• Select the specific product type required

• ICH Q8 & Quality by Design

• Medicinal product production and scale up

• Process validation requirements for different dosage forms

• Stability programmes and data requirements

• When/how to deal with changes during development to ensure this does not invalidate clinical/other data already generated

The Organisation for Professionals in Regulatory Affairs

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