Organizer: Royal Statistical Society

Venue: The Royal Statistical Society

City: London

Country: United Kingdom

Postcode: EC1Y 8LX

Description:

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

Event type:
  • Workshops and courses

Keywords: HDRUK

PSI Scientific Committee Webinar: Statistical Challenges in Analytical Comparability and Biosimilarity Assessment https://tess.elixir-europe.org/events/psi-scientific-committee-webinar-statistical-challenges-in-analytical-comparability-and-biosimilarity-assessment 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 Royal Statistical Society The Royal Statistical Society, London, United Kingdom The Royal Statistical Society London United Kingdom EC1Y 8LX [] [] [] workshops_and_courses [] HDRUK