Biosimilars – Understanding Regulatory Challenges Course

May 4, 2012 7:38 AM

The Center for Professional Innovation and Education (CfPIE) is organizing a training course: “Biosimilars – Understanding Regulatory Challenges” in Los Angeles, California.

The event will take place in The Hilton Los Angeles on 25-26 June 2012.

At the end of the 2 day course you will:

  • Gain a firm understanding of the CMC, Nonclinical and Clinical regulatory requirements and expectations (FDA, EMA and WHO) for biosimilar biological products
  • Appreciate why biosimilars are not treated by the regulatory authorities as bio-generics, and the significant differences between biosimilars and generic chemical drugs
  • Learn the totality of what is to be present in the submitted comprehensive, scientific biosimilarity exercise – what has worked, what has not, in bringing biosimilars into the marketplace.

The website of the conference is: CfPIE Biosimilars

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