Introduction:

Welcome to the IMMUNOIMPACT: Immunogenicity Insights & Strategies Masterclass 2025, an intensive and informative workshop designed to explore the complexities of immunogenicity while ensuring compliance with the European Medicines Agency’s (EMA) guidelines. Over two days, we will examine key concepts, methodologies, and practical approaches to understanding and managing immunogenicity in the context of therapeutic interventions.

Key Takeaways:

Participants will gain insights into the following topics:

• Immunogenicity and Antigenicity
• Generation and management of Anti-Drug Antibodies (ADAs) in immunogenicity
• Clinical configurations and procedures for monitoring immunogenicity
• Utilization of animal data to navigate clinical challenges
• Development of diagnostic tools and technologies
• Role of drugs in combating serious adverse events
• Advanced bioinformatics and procedure verification
• Product evolution and addressing complexities
• Immunogenicity surveillance in pharmacovigilance
• Analysis of safety approaches
• Assay methods for ADA quantification
• Regulatory compliance in alignment with EMA guidelines

Who Should Attend:

1. Immunologist
2. Clinical Research Scientist
3. Regulatory Affairs Specialist
4. Pharmaceutical Scientist
5. Drug Safety Officer