×
Don't Miss Out!
Get your weekly Breakfast Briefing eNewsletter, filled with news, trends, and vital information from DIA!
Back to Agenda
Session 0707: CMC REQUIREMENTS FOR THERAPEUTIC BIOLOGICAL PRODUCT AT DIFFERENT CLINICAL DEVELOPMENT STAGE (PART I)
Session Chair(s)
Melly Lin
CMC Regulatory Policy Lead, Pharma Technical Regulatory
F. Hoffmann-La Roche Ltd, Switzerland
Speaker(s)
Regulatory Perspectives on Manufacturing Changes and Comparability Study for Biotechnology Products
Lixin Xu, MD, PhD
USA, FDA, United States
Senior Product Quality Reviewer
Regulatory expectations for specification setting at different stages of clinical development
Wallace Lauzon
Health Canada, China
Acting Chief of the Cytokines Division
Have an account?