Module 9 2024

03/09/2024

Presentation Structure

• Why is Module 3 Important?

• Evolution of Module 3 alongside product development

• Module 3 Differences Inherent in Biologics

Module 3 Level of Detail

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• General Structure of Module 3

• Specific Module 3 Components

Practical Considerations

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Conclusion

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The Organisation for Professionals in Regulatory Affairs

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Why is Module 3 Important?

• The philosophy of Module 3 is different to that of Modules 4 & 5 – specifically Module 3 represents a combination of the CMC development + future manufacturing agreements & compliance

• Getting an appropriate Module 3 approved can save companies considerable time, resources, complexity and ultimately money – particularly with global products

• The EU currently considers your entire Module 3 as effectively Established Conditions (ICH Q12) but this may evolve with the new Pharmaceutical Legislation

The Organisation for Professionals in Regulatory Affairs

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