Debra Litwak
Consultant Avidity Biosciences, Inc.
Seminars
Wednesday 15th July 2026
Panel Discussion: Driving Smarter Decisions by Clarifying the Role of RWD in EAPs
2:00 pm
- 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
Thursday 16th July 2026
Chair’s Opening Remarks
8:20 am
