A Rapidly Changing Regulatory Landscape: What Medical Affairs Leaders Should Know

Recent shifts in U.S. health policy—from revised vaccine recommendations and NIH budget cuts to proposed bans on direct-to-consumer pharma advertising—are redefining the regulatory environment in which Medical Affairs operates. As the pace of change accelerates, Medical Affairs professionals must be proactive in understanding how emerging legislation, transparency expectations, and cost-containment strategies may impact their work.

This session brings together seasoned experts and leaders in Medical and Regulatory Affairs to explore the implications of a rapidly evolving policy landscape. Topics will include real-world examples of recent or proposed changes and practical steps Medical Affairs leaders can take to ensure compliance, maintain public trust, and remain agile in an uncertain environment.

Learning Objectives

1. Recognize how recent and proposed healthcare policy changes may impact Medical Affairs operations, strategy, and compliance expectations.
2. Understand the increasing emphasis on transparency, conflict-of-interest management, and ethical decision-making in a changing regulatory climate.
3. Identify proactive steps Medical Affairs leaders can take to align cross-functional teams and ensure preparedness in the face of regulatory shifts.
4. Explore how automation, digital tools, and audit-ready systems can support compliance, adaptability, and strategic decision-making.

Speakers: