Module 9 2021

19/03/2021

Impact Definitions

CASSS.org A-mAb Case Study - https://cdn.ymaws.com/www.casss.org/resource/resmgr/imported/a- mab_case_study_version_2-1.pdf ATAs are Anti-therapeutic antibodies other names ADA – anti drug antibodies.

The Organisation for Professionals in Regulatory Affairs

13

Control of CQA’s

The Organisation for Professionals in Regulatory Affairs

14

7