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Session 1: Biosimilar Medicines Regulatory Framework Review
Session Chair(s)
Virginia Acha
AVP, Science and Regulatory Policy, Merck & Co., Inc., United Kingdom
Speaker(s)
Strategic Planning and Regulatory Landscape for the Development of Biosimilars
Christian Maasch
Managing Consultant, Product Development and RA, Xendo, Germany
Statistical Approaches to Quality Comparability
Thomas Lang, MSc
Senior Statistical Assessor, Austrian Agency for Health and Food Safety (AGES), Austria
Regulatory Considerations for Complex and Synthetic Peptides
Inger Mollerup, MS, MSc
Consultant, Inger Mollerup Regulatory Consulting, Denmark
Tailored Clinical Programmes
Alex Kudrin
Biopharmaceutical Consultant, United Kingdom
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