Uwe Gudat | Head of Safety, Biosimilars
Fresenius Kabi

Uwe Gudat, Head of Safety, Biosimilars, Fresenius Kabi


Day Two World Drug Safety Congress EU 2018 @ 15:20

Evaluating the clinical safety of a biosimilar: totality different and/or exactly the same?

  • The “Totality of evidence”: integrating evidence across domains
  • A Bayesian perspective on the clinical safety of candidate biosimilars
  • Reflecting on residual uncertainty: the tension between a medico-scientific and a legal perspective

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