Module 9 2024

03/09/2024

Module 9: Registration of Biological, Biotechnology and Advanced Therapy Products

Quality / CMC Considerations

Zeb Younes, Head of Development and Principal Consultant at Scendea

10 Sept 2024

The Organisation for Professionals in Regulatory Affairs The Organisation for

Professionals i Regulatory Affairs

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Agenda

Goal: to provide an overview of core CMC principals in drug development

• Overview of Drug Development Pathway (CMC focus)

Control Strategy

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Comparability

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Special Cases

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• Common scenarios and response planning

Final Messages

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The Organisation for Professionals in Regulatory Affairs

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