Biosimilars
Biosimilar Webcast 1

We invite you to participate in a webcast:

Biosimilars: Overview of the European Medicines Agency (EMA) Experience

This webcast is brought to you by Amgen. 


Thomas Felix, MD
Regulatory Affairs Director 
Amgen, Inc.
Thousand Oaks, CA


The faculty for this webcast will: 

  • Describe the regulatory pathway for European Medicines Agency (EMA) approval of biosimilars
  • Discusse key requirements for biosimilar product approval based on EMA scientific guidelines
  • Compare an innovator application versus a biosimilar application data package
  • Describe the challenges with pharmacovigilence
  • Discusse product naming and automatic substitution
  • Review approvals, withdrawals, and rejections of biosimilar application submissions to EMA
  • Highlight regulatory pathways established by other countries for biosimilars


Registration Information:
The webcast will be presented on Wednesday
December 12, 2012 at 12pm EST and again at 5pm EST. After registering, you will receive a confirmation email containing information about joining the webcast.

Please select the date/time that you are registering for: 


WednesdayDecember 12, 2012 at 12pm EST
WednesdayDecember 12, 2012 at 5pm EST

WednesdayJanuary 30, 2013 at 12pm EST
WednesdayJanuary 30, 2013 at 5pm EST

TuesdayFebruary 19, 2013 at 12pm EST
TuesdayFebruary 19, 2013 at 5pm EST

We look forward to your participation! 

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