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In Vitro and In Vivo Preclinical Testing of Biosimilars: What Have We Learned?
Session Chair(s)
David Jones, MS
Consultant, Regulatory Pharmaco-Toxicologist
ApconiX, United Kingdom
This session will examine the nonclinical requirements for the safety assessment of biosimilars. We will also review EU and US regulatory requirements and efforts to harmonize approaches.
Learning Objective : Review nonclinical testing requirements for biosimilars; Discuss EU regulatory requirements; Discuss US regulatory requirements.
Speaker(s)
Introduction to Biosimilars and Global Regulatory Guidelines
David Jones, MS
ApconiX, United Kingdom
Consultant, Regulatory Pharmaco-Toxicologist
Comparing Complex Medicines Using Multisystem Gene Expression Profiling: A Critical Piece of the “Sameness” Puzzle
Iris Grossman, PhD
Teva Pharmaceutical Industries Ltd., Israel
Vice President, Global Head of Personalized Medicine and Pharmacogenomics
Animal Studies With Biosimilars: Where Do We Stand?
Paul Baldrick, PhD
Covance Inc., United Kingdom
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Registration override should work.