Immunogenicity of Biologics, Biopharmaceuticals & ATMPs

Immunogenicity of Biologics, Biopharmaceuticals & ATMPs – Live Online Training Course

Join this advanced professional training course focused on Immunogenicity of Biologics, Biopharmaceuticals, Biosimilars, Vaccines, Monoclonal Antibodies (mAbs), and Advanced Therapy Medicinal Products (ATMPs). The event will take place on 23–24 September 2026, from 13:00 CEST to 18:00 CEST, and will be delivered as a live online instructor-led training course, allowing participants from around the world to attend remotely.

As biologics and ATMPs continue to transform modern healthcare, managing unwanted immunogenicity remains a critical challenge throughout product development. This comprehensive training provides practical knowledge on immunogenicity risk assessment, anti-drug antibodies (ADA), bioanalytical methods, assay development, quality control, regulatory compliance, and risk mitigation strategies.

The course will be led by renowned industry experts Dr. Thorsten Meyer (Germany), Marion Prior (Austria), and DI Markus Roucka (Austria), who bring extensive experience in biologics development, clinical analytics, regulatory affairs, and immunogenicity assessment. Through expert presentations, case studies, interactive discussions, and Q&A sessions, attendees will gain actionable insights into the latest industry practices and regulatory expectations.

Key Topics Covered

• Immunogenicity and ADA characterization

• Bioanalytical assay development and validation

• Immunogenicity risk assessment and mitigation

• Regulatory requirements and global guidelines

• Preclinical and clinical immunogenicity considerations

• Quality control and analytical testing strategies

• Biosimilars, vaccines, monoclonal antibodies, and ATMPs

• Case studies and practical industry examples

Who Should Attend?

This training is ideal for:

• Bioanalytical and Analytical Development Professionals

• Product Development Scientists

• Clinical Development Teams

• Regulatory Affairs Specialists

• Quality Assurance and Quality Control Professionals

• Biotechnology and Pharmaceutical Researchers

• CRO Representatives

• R&D Scientists working with biologics and complex therapies

• Clinicians and Principal Investigators

• Members of Regulatory Agencies and Health Authorities

Benefits for Participants

• Learn directly from internationally recognized experts

• Understand EMA and FDA expectations for immunogenicity assessment

• Gain practical strategies for ADA monitoring and risk management

• Explore real-world case studies and development challenges

• Network with global life sciences professionals

• Receive comprehensive digital training materials

• Earn a Certificate of Completion

Mode of Event: Live Online Training

Date: 23–24 September 2026

Time: 13:00–18:00 CEST

Place: Virtual / Online

Special thanks to the expert trainers and the Fleming Events team for delivering this high-quality educational experience for the global biotechnology and pharmaceutical community.

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