Immunogenicity of Biologics, Biopharmaceuticals & ATMPs IMMUNO ATM on September 23-24, 2026 in Bratislava, Slovakia

**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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