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Day One
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Day One
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Regulatory standards in the EU and USA
- Robert Zoubek - Senior Consultant, Granzer Regulatory Consulting & Services
How approaches to variations differ in the EU and FDA and how different changes will be handled in the different regions
- Robert Zoubek - Senior Consultant, Granzer Regulatory Consulting & Services
Relevant guidelines
- Robert Zoubek - Senior Consultant, Granzer Regulatory Consulting & Services
Analytical considerations – Demonstrating comparability based on physicochemical and biological studies
- Robert Zoubek - Senior Consultant, Granzer Regulatory Consulting & Services