PSI Webinar: Statistical Challenges in Analytical Comparability and Biosimilarity Assessment

 
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Tuesday 15 October 2019, 02:00pm - 03:30pm

 

Speakers: 

  • Thomas Lang (EMA BSWP / AGES)
  • Johanna Mielke (Bayer)
  • Bruno Boulanger (Pharmalex)

About the event:

This webinar will discuss statistical requirements for the assessment of analytical comparability and similarity assessments, for example between biosimilars and reference products or before and after manufacturing changes. This topic has been the subject of a recent EMA reflection paper and an EFSPI working group. New strategies are proposed as an alternative to mean comparisons and include the assessment of ranges, inferential approaches or the use of Bayesian methods.

Full information about the webinar and the registration page are available at the following link: https://www.psiweb.org/events/event-item/2019/10/15/default-calendar/psi-scientific-committee-webinar-statistical-challenges-in-analytical-comparability-and-biosimilarity-assessment

Organiser Name Rosalind Leach

Email Address This email address is being protected from spambots. You need JavaScript enabled to view it.

Organising Group(s) PSI

 

 

 

 

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