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Online Live Training Features

All sessions of this unique course online

Live interaction options between the delegates and trainer

Available via mobile, tablet or laptop

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Meet the training leaders

  • Dr. Markus Fido
  • Managing Director
  • Mfi Bioconsulting, Austria
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  • Dr. Florian Cymer
  • F. Hoffmann-La Roche Ltd.
  • Switzerland
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  • DI(FH) Rainer Fedra
  • VelaLabs GmbH, Austria
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Key topics

Bioassays for Immunogenicity testing

Principles and development of GCLP Bioanalytics

Bioassays for characterization of monoclonal antibodies

Case studies: Selected bioassays under characterization & control

Key takeaways

Understand

  • The need for characterization of Biopharmaceuticals & Biosimilars
  • Bioanalytical method development, optimization & validation
  • Biostatistics for bioanalytical data evaluation

Learn

  • About EMA & FDA Bioassays & Bioanalytics Regulatory Updates
  • How to characterize potency or strength of a biopharmaceutical drug
  • How to design a bioassay validation protocol or report

Gain

  • Principles and development of GCLP Bioanalytics
  • Practical approach to biological assay validation
  • Insight into a DOE for a Bioassay

Ticket

Delegate Fee

from 1396 € Buy

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