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PSI Scientific Committee Webinar: Statistical Challenges in Analytical Comparability and Biosimilarity Assessment 15th October 2019, 2:00pm to 3:30pm (UK time) Speakers: * Thomas Lang (EMA BSWP / AGES) * Johanna Mielke (Bayer) * Bruno Boulanger (Pharmalex) 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 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 Rosalind Leach Senior Statistician T: +44 118 977 0077 www.numerus.com Numerus Ltd, Longstaff House, 47a Denmark Street, Wokingham, RG40 2AY, United Kingdom Registered in England with NO 5726918 whose registered office is at Eastgate House, 11 Cheyne Walk, Northampton, NN1 5PT, United Kingdom You may leave the list at any time by sending the command SIGNOFF allstat to [log in to unmask], leaving the subject line blank.