Panel Discussion: Driving Smarter Decisions by Clarifying the Role of RWD in EAPs

• Comparing how FDA, EMA, and national health authorities interpret the use of RWD in expanded and post-trial access programs
• Examining differing company approaches, from limiting programs to treatment-only access to actively incorporating structured evidence generation
• Exploring real-world examples of where regulators accepted or rejected RWD submissions in filings and approvals
• Defining the boundaries of ethical and compliant RWD collection when patient care is the primary purpose

Speakers:

Romina Oxborough

CEO

Maprium

Debra Litwak

Consultant

Avidity Biosciences, Inc.

Kashina Bugayong

Program Led

Ultragenyx Pharmaceutical Inc.

Amelia Spinrad

Associate Director

Gilead Sciences