09:00 - 11:00120 mins
Regulatory standards in the EU and USA
11:00 - 13:00120 mins
How approaches to variations differ in the EU and FDA and how different changes will be handled in the different regions
13:00 - 14:0060 mins
14:00 - 15:0060 mins
15:00 - 17:00120 mins
Analytical considerations – Demonstrating comparability based on physicochemical and biological studies
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