Module 9 2021

16/03/2021

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

• General Structure of Module 3 • Specific Module 3 Components • Practical Considerations • Conclusions

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)

The Organisation for Professionals in Regulatory Affairs

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