Monoclonal Antibodies Quality & Regulatory Requirements (Monoclonal Regulatory Training)
Bratislava, Slovakia, October 13, 2026
TL;DR
The Monoclonal Antibodies Quality & Regulatory Requirements training course provides comprehensive insights into the evolving regulatory landscape and quality expectations for biologics and advanced monoclonal antibody products. The program focuses on critical topics including International Council for Harmonisation quality guidance, process characterisation, comparability protocols, Quality by Design (QbD), analytical product profiling, and lifecycle management strategies.
About the Event
Monoclonal Antibodies have developed and evolved from the early forms derived in ascitic fluid to multibillion drugs manufactured in ton quantities. In the early days of Monoclonal antibody development, the approaches now considered routine such a biosimilars and Antibody Drug Conjugates were not considered as feasible, yet they are. The current guidance and approaches offer significant flexibility within the regulatory framework, yet the industry still adopts a more conservative approach.
This course will encourage the adoption and the utilisation of the full extent of the current regulatory guidance and share practical examples as to how to achieve.
Organization
Monoclonal Antibodies Quality & Regulatory Requirements is organized by Fleming
Date and Location
The lecture will take place in Bratislava, Slovakia on October 13, 2026.
Attendance to the this lecture is Online.
For more information, you can click here to access to the event website.