戻る Agenda
Quality Considerations for Biosimilarity
Session Chair(s)
Sundar Ramanan, PHD
Director, Global Biosimilars R&D Policy
Amgen Inc., United States
Speaker(s)
Post Approval Regulatory Considerations for Biosimilars
Gustavo Grampp, PHD
Amgen Inc., United States
Executive Director Global Operations
Level of Physicochemical and Biological Similarity
Emily Shacter, PHD
ThinkFDA, LLC, United States
Independent Consultant
Role of Functional Assays in the Assessment of Similarity
Cornelius Fritsch, PHD
Novartis Pharma AG, Switzerland
Fellow, External Bioassay Support
Drug Product Development of Biosimilars: Quality by Design Considerations and Strategies
Krishnan Sampath, PHD
Hospira Inc., United States
Associate Director, Formulation and DP Process Development, Global Biologics R&D
Practical Considerations for Biosimilarity Development
Jim Anderson, PHD
Momenta Pharmaceuticals, United States
Vice President, Analytical Development
Panel Discussion
All Session Speakers, United States