Thomas Lang (EMA BSWP / AGES) - Setting the Scene: The regulatory landscape – a journey through time
Bruno Boulanger (Pharmalex) - Analytical similarity and comparability: what is the question ?
Johanna Mielke (Bayer) - The assessment of quality attributes for biosimilars: a statistical perspective on current practice and a proposal
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.
This webinar is free for PSI members to attend but has a charge of £20 for non-members. To register please click here.
(EMA BSWP / AGES)
Thomas Lang is biostatistician by training. He spent eight years in academic research, followed by three years in clinical research in the pharmaceutical industry. He currently works as senior statistical assessor for the Austrian Agency for Health and Food Safety. For more than nine years he was a member of the Scientific Advice Working Party at EMA. In his current role of a member of the Biostatistics Working Party Thomas acted as rapporteur for the EMA Reflection paper on statistical methodology for the comparative assessment of quality attributes in drug development.
Bruno Boulanger (Pharmalex)
Bruno has 25 years of experience in several areas of pharmaceutical research and industry including discovery, toxicology, CMC and early clinical phases. He holds various positions in Europe and in USA. Bruno joined UCB Pharma in 2007 as Director of Exploratory Statistics. Bruno is also since 2000 Lecturer at the Université of Liège, in the School of Pharmacy, teaching Design of Experiments and Statistics. He is also a USP Expert, member of the Committee of Experts in Statistics since 2010. Bruno has authored or co-authored more than 100 publications in applied statistics.
Johanna Mielke (Bayer)
Johanna studied Statistics at TU Dortmund University (Germany). Afterwards, she joined the Statistical Methodology Group at Novartis in Basel (Switzerland) as a Doctoral Candidate. Her research was focussed on the development of statistical methodologies for clinical biosimilar development. After completing her Ph.D. in 2018, Johanna started to work as a Data Scientist at Bayer in Wuppertal (Germany).
Joint PSI, EFSPI & ASA BIOP Webinar: Estimands
PSI, the European Federation of Statisticians in the Pharmaceutical Industry (EFSPI) and the Biopharmaceutical Section of the American Statistical Association (ASA) are jointly organising a webinar on Estimands in Practice. Speakers from regulatory authorities (FDA and EMA) and industry will present on their experience on this topic to date.
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