Tuesday, March 20th
15:00 PM – CEST / 09:00 AM EDT
Providing quality to patients, reducing production costs and facilitating new drug process approvals
In this complimentary webinar, our experts discuss Quality by Design, Design of Experiment, Bayesian statistics, Risk, Control Strategy and Comparison. We explain analytical methods developed to support and control various processes and discuss examples from case studies.
At end of the webinar, Dr. Bruno Boulanger will answer your questions in a Q&A session.
Key learnings:
- Quality by Design strategy to successfully implement a model-based process development and evaluate its relation to risk
- Understanding Data Science concepts such as Design Space and Value of Modeling
- Connecting the dots between processes, analytical procedures and clinical trial results for a comprehensive development, qualification and process control
You may address your questions at: contact@pharmalex.com
Featured Speaker:
Dr. Bruno Boulanger, CSO, Company Co-Founder of Arlenda, PharmaLex Statistical Division
Dr. Bruno Boulanger holds a PhD in Experimental Psychology from the University of Liège (Belgium). After a post-doctorate at the Université Catholique de Louvain (Belgium) and the University of Minnesota (USA) in Statistics applied to simulation of clinical trials, he joined Eli Lilly in Belgium in 1990. He has gathered 20 years of experience in several areas of pharmaceutical research and industry including discovery, toxicology, CMC and early clinical phases. He held various positions in Europe and in the US. Since 2000, Dr. Boulanger is Senior Lecturer at the Université of Liège, in the School of Pharmacy, teaching Design of Experiments and statistics. He organizes and contributes to Non-Clinical Statistics in Europe. In 2010, he set up the First Applied Bayesian Statistics conference. He is also a USP Expert, member of the Committee of Experts in Statistics. Dr. Boulanger has authored or co-authored more than 100 publications in applied statistics.