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Bioassays & Bioanalytical Methods

  • 26/09/2018 - 28/09/2018
  • Vienna, Austria

Meet your prominent trainers

  • Dr. Mahdi Adibzadeh
  • Group Head Analytical R&D and QC
  • Hoffmann-La Roche
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Key topics

Bioassays & Bioanalytics Regulatory Updates

Characterization of biotherapeutics: requirements and challenges

 

Bioassay development strategies

Biostatistics for Bioanalytical Data

Biological Assay Validation

Principles and development of GCLP Bioanalytics

 

Takeaways

Understand

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

Learn

  • About EMA & FDA Bioassays & Bioanalytics Regulatory Updates
  • To prepare Standard Operating Procedures (SOPs)
  • How to design a bioassay validation protocol (workshop)

Gain

  • Principles and development of GCLP Bioanalytics
  • Practical approach to biological assay validation
  • Regulatory background for advanced therapy medicinal products (ATMPs)

Training features

Interactive sessions & workshop

Individual case by case consultancy with the trainer

Comprehensive printed and digital course documentation

5H+ of Networking with industry experts

Case studies from the trainer's experience

Certificate of Completion issued by the Trainer

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Delegate Fee

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