Due to regulatory uncertainty, difficult patient recruitment, and growing costs, U.S. biotech companies are increasingly looking to Europe to conduct clinical trials and build Medical Affairs functions to prepare for launch.

But how do Medical Affairs departments scale internationally, maintain compliance, and deliver value while managing headcount and resource limitations?

In this session, two Medical Affairs leaders will share case studies illustrating how they built global organizations with lean U.S. teams—offering practical insights for achieving efficiency, maintaining quality, and driving meaningful global impact.

Learning Objectives

1. Identify common challenges faced when establishing or expanding Medical Affairs organizations globally with limited resources.
2. Explore the business case for building vs. outsourcing and describe the upskilling needed to achieve impact.
3. Apply practical strategies for maintaining oversight, quality, responsiveness, and compliance in lean Medical Affairs structures.