Immunogenicity of Biologics, Biopharmaceuticals & ATMPs

Days
Hours
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Online Live Stream

Immunogenicity of Biologics, Biopharmaceuticals & ATMPs

Training features

Interactive discussions and Q&A sessions
Individual discussion & consultancy with the trainer

Case studies from the trainer's experience
Certificate of completion issued by the trainer
Comprehensive course documentation
Fully online

All sessions of this unique course also online

Live interaction

Live interaction options between the delegates and trainer

On any device

Available via mobile, tablet or laptop

Course description

With the increasing complexity of today’s therapeutics like Biologics, Biopharmaceuticals, Biosimilars & ATMPs, the unique issues have emerged especially in managing immunogenicity in clinical practice and during drug development.

Understanding regulatory and quality requirements as well as applying the appropriate analytics and effective clinical monitoring to detect ADAs (Anti-Drug-Antibodies) are becoming essential for successful drug development & patient safety. Distinct approaches to control ADAs & safeguard human subjects need to be considered.

This 2-day course brings practical & in-depth understanding of immunogenicity in pre-clinical and clinical development, and brings clarifications on regulation, requirements, and quality concerns.

Join us in Vienna to find solutions for your immunogenicity challenges and learn from case studies on mAbs, ATMPs & Biosimilars.

meet the training leaders
Dr. Markus Fido
Owner, Managing Director
Mfi Bio-Consulting, Austria
training

Brochure

Reveal the full schedule of the training as well as key topics, course objectives, key takeaways, special features, and the trainer bio!

Immunogenicity of Biologics, Biopharmaceuticals & ATMPs Fleming Agenda cover
Immunogenicity of Biologics, Biopharmaceuticals & ATMPs Fleming Agenda cover
Immunogenicity of Biologics, Biopharmaceuticals & ATMPs Fleming Agenda cover
key training

Topics

Guidelines, regulatory & quality requirements for immunogenicity

Immerging into the field of immunology & immune reactions

Different factors which may impact immunogenicity

Analytical development – screening, confirmation & neutralization assays

Characterization and monitoring of ADAs with appropriate analytical tools

Study design & bioanalytical methods as characterization tools

Immunogenicity risk assessment & mitigation

Clinical development – pitfalls & challenges, strategies to avoid ADA formation

Clinical synopsis with special emphasis on immunogenicity

Case studies on mAbs, ATMPs & Biosimilars

Benefits of attending

Testimonials

Registration

Training ticket

Online Live Stream
FROM
1496
Delegate Fee
FROM
2396

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