Module 3 Presentations

07/05/2024

Summary

• A coherent ‘story’ is required in the Dossier • Begin development with a Target Product Profile • QbD, traditional or hybrid approach acceptable • Ask yourself: • ' Do I understand how my product has been developed ' • If you don’t…….the assessor will most likely not understand!

The Organisation for Professionals in Regulatory Affairs

31

• ICH Q8-Q10 References and Further Reading

The Organisation for Professionals in Regulatory Affairs

32