2018 PDA Biosimilars Workshop

Sept. 26, 2018 – Sept. 27, 2018  • Washington, D.C.

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At the 2018 PDA Biosimilars Workshop, representatives from the U.S. FDA, EMA, and Health Canada will share the most common challenges they’ve identified in biosimilar applications. Learn ways to tackle these technical obstacles and gain practical approaches to avoid the pitfalls frequently encountered during biosimilar candidate development, including:

  • Expectations for manufacturing development and control strategies
  • Compliance standards for analytical similarity data
  • The application of statistical tools, including practical challenges, potential solutions, and considerations for the analytical similarity study design

Whether you work in the development, manufacture, or marketing of biosimilars, you don’t want to miss this Workshop!