EU Regulatory CMC Strategies and Challenges

Description: Biologics are more complex than small molecules and have unique practical challenges and issues that can arise during their review. Small molecules, while not as complex, have their own idiosyncrasies that can trip up product development.
This session will evaluate the common challenges associated with both monoclonal antibodies and small molecules for EMA applications. It will outline the best strategies to overcome these challenges and will be illustrated by the use of real life examples and case studies.
Lastly, the session will provide a regulator’s perspective on what is potentially changing in the CMC regulatory landscape going forward.

By the end of this topic, participants should have a clear understanding of how to effectively plan and execute a CMC regulatory strategy, and be able to apply these strategies to their own product development processes in order to minimize the risk of CMC-related issues and ensure a successful review and approval outcome.