Module 5 Presentations

16/07/2024

Assessment and control of DNA reactive (mutagenic) impurities – ICH M7, Step 2, Feb 2013

https://database.ich.o rg/sites/default/files/M 7_R1_Guideline.pdf

The Organisation for Professionals in Regulatory Affairs

Module 5 Lecture 3 – Nonclinical safety assessment

37

Biopharmaceuticals What’s the difference?

The Organisation for Professionals in Regulatory Affairs

Module 5 Lecture 3 – Nonclinical safety assessment

38

19