Exploring Requirements for Characterisation & Control of ADCs: A Regulator’s Perspective

• Understanding the NCA´s perspective to ADC regulatory CMC as a promising emerging modality
• Offering scientific advice and principles for ADC regulatory CMC strategy
• Laying out commonly asked questions raised by sponsors in Clinical Trial Applications for ADCs

Speakers:

Christian Merz

Assessor, Non-Clinical/Quality, Antibody Therapeutics

Paul-Ehrlich-Institute