Panel: Building Ethical Frameworks for Post-Trial Responsibilities

• Understanding post-trial ethical responsibilities across drug development
• Frameworks for continued access to investigational medicines and devices
• Navigating unexpected, early discontinuations to ensure regulatory requirements and post-trial ethical obligations are met
• Key lessons learned from implementing frameworks, evaluation processes, and governance structures within a large organization

Speakers:

Missy Heidelberg

Head, Bioethics

Takeda

Sarah White

Executive Director, Multi-Regional Clinical Trials Center

Harvard