Monoclonal Antibodies Quality & Regulatory Requirements MONOCLONAL on October 13-14, 2026 in Vienna, Austria

The Monoclonal Antibodies: Quality & Regulatory Requirements training course provides an in-depth exploration of the evolving regulatory landscape and quality expectations for biologics development. As monoclonal antibodies continue to grow into complex, high-value therapeutics, understanding regulatory flexibility while maintaining compliance is critical.

This program delivers practical insights into global regulatory frameworks, including guidance from the International Council for Harmonisation, alongside expectations from agencies such as the U.S. Food and Drug Administration and European Medicines Agency. Participants will gain a strong understanding of process characterisation, validation, comparability, and control strategies across the product lifecycle.

The course emphasizes real-world case studies, analytical product profiling, and regulatory considerations for advanced modalities such as biosimilars, bispecific antibodies, and antibody-drug conjugates. Attendees will also benefit from interactive discussions and practical approaches to overcoming common development and manufacturing challenges.