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