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Global Developments in the Regulation of Biological Therapeutics
Session Chair(s)
Andrew Robertson, JD, PhD
Vice President, Head of Global Regulatory Policy and Innovation
Takeda, United States
This session will discuss recent developments in global biotherapeutics regulation, including originator biologics and biosimilars. The focus is on key events, the emergence of new analytical tools, new advocacy efforts, and how these impact developed markets.
Learning Objective : Discuss recent developments in biologics and biosimilars regulations within both emerging and developed markets; Identify areas of current debate, review recent milestone events, anticipate market and regulatory issues on the horizon.
Speaker(s)
Interdisciplinary Perspectives on Development of Naming Standards for Biosimilar Medicines
John J. Lewis, MA
Association of Clinical Research Organizations (ACRO), United States
Senior Vice President, Policy and Public Affairs
The Journey To The First Biosimilar Approach In The US: A Sponsor's Perspective
Hillel P Cohen, PhD
Sandoz Inc., United States
Executive Director, Scientific Affairs
Global Biosimilars Regulations: Key Topics and Open Issues
Kimberly Greco
Amgen Inc., United States
Director, Research and Development Policy
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