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Comparability For Biologics

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Starting 10 October - 12 October, 2022
3 day LIVE Online Course starting 1PM to 5PM GMT
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Day Two | October 11, 2022keyboard_arrow_right

Day Two | October 11, 2022

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Day Two | October 11, 2022

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Regulatory expectations for two major changes: site transfer and scale-up
  • Robert Zoubek - Senior Consultant, Granzer Regulatory Consulting & Services
Designing a clinical comparability programme
  • Robert Zoubek - Senior Consultant, Granzer Regulatory Consulting & Services
Biosimilar perspective – analytical similarity and the comparability exercise
  • Robert Zoubek - Senior Consultant, Granzer Regulatory Consulting & Services
Applying modern concepts such as PAT and Design Space
  • Robert Zoubek - Senior Consultant, Granzer Regulatory Consulting & Services
Exercise
Your turn as a reviewer!
  • Robert Zoubek - Senior Consultant, Granzer Regulatory Consulting & Services
Regulatory implications of getting the comparability exercise wrong
  • Robert Zoubek - Senior Consultant, Granzer Regulatory Consulting & Services
Day One | October 10, 2022
NextDay Three | October 12, 2022
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