DIA 48th Annual Meeting
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Regulatory Roundtable on Biosimilars
Track : Track 08: Regulatory Affairs and Submissions
Program Code: 134
Date: Monday, June 25, 2012
Time: 1:30 PM to 3:00 PM  EST
CHAIR :
 Joseph Scheeren, Bayer Healthcare Pharmaceuticals, United States
PRESENTER (S):
 Chih-Hwa Wallace Lin, Center for Drug Evaluation
 Leah Christl, FDA, United States
 Peter Richardson, European Medicines Agency, United Kingdom
Description
This forum will explore the challenges of biosimilars in light of the recent policy developments in the US, EU, and Asia. Participants will hear from a roundtable of authorities on how to address biosimilars and the opportunities for the future.

Learning Objectives:
Discuss the current status of biosimilars (focusing on US, EU, and Asia)
Identify challenges and opportunities for the future.