PDA/FDA Biosimilars Conference - 26-27 June 2017

FDA

3 May 2017 - The FDA and PDA are co-sponsoring a conference to identify best practices for global development and approval for biosimilars.

The conference wil examine:

  • Risk-based approaches to setting product specifications for quality attributes
  • Practical solutions for establishing suitable control strategies over the biosimilar product lifecycle
  • Approaches for global post-marketing change control
  • Expectations for demonstrating analytical similarity

Read FDA blog

Michael Wonder

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Michael Wonder

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Medicine , US , Biosimilar , Workshop