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International training

Bioassays & Bioanalytical Methods

Three-day training focused on requirements and challenges in characterization of biotherapeutics using bioassays and bioanalytics. Biostatistics, bioassay validation and GCLP will be covered too.

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

CUSTOMIZE THIS TRAINING TO YOUR COMPANY NEEDS

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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JOIN US IN Vienna

Hotel Trend Savoyen Vienna

Rennweg 16, 1030, Vienna, Austria

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