Meet the training leaders
- Dr. Markus Fido
- Managing Director
- Mfi Bioconsulting, Austria
- Dr. Florian Cymer
- F. Hoffmann-La Roche Ltd.
- Switzerland
- DI(FH) Rainer Fedra
- VelaLabs GmbH, Austria
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
- The need for characterization of Biopharmaceuticals & Biosimilars
- Bioanalytical method development, optimization & validation
- Biostatistics for bioanalytical data evaluation
- 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
- Principles and development of GCLP Bioanalytics
- Practical approach to biological assay validation
- Insight into a DOE for a Bioassay
Contact us
- Andrea Weber
- Sr. Manager for Pharma
- Phone: +421 257 272 232
- Email: event.inquiries@fleming.events