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Bioassays & Bioanalytical Methods Training

  • 20/02/2019 - 22/02/2019
  • Vienna, Austria

Meet your prominent trainer

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

Bioanalytics & Bioassay Regulatory Updates

Biostatistics for Bioanalytical Data Evaluation

Bioassay development strategies

Biological Assay Validation

Characterization of biotherapeutics : requirements and challenges

Principles and development of GCLP Bioaanalytics

Takeaways & Special Features

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

• To characterize a Biosimilar of Biopharmaceutical drug

• How to design a bioassay validation protocol at the workshop

Gain

• Principles and development of GCLP Bioanalytics

• Practical approach to biological assay validation

• Regulatory background for advanced therapy medical products (ATMPs) according to ICH Q6B

Training features

Interactive sessions & workshop

Comprehensive printed and digital course documentation

Individual case by case consultancy with the trainer

5H+ of Networking with industry experts

Case studies from the trainer's experience

Certificate of Completion issued by the Trainer

REGISTRATION

Delegate Fee

from 2596 € Buy

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Based on your requirements, we will build a practical training including content tailored to your specific needs, our cutting edge methodologies and relevant modules from our training portfolio.

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