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Comparability For Biologics

LIVE Online Course Running April 24-26, 2023
3-Day Sessions Running Daily

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Day Onekeyboard_arrow_right

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
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