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 unique 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.
