Sara Radenovic
Director, Managed Access Programs Bristol Myers Squibb
Seminars
Thursday 26th March 2026
Operating EAPs In-House, Hybrid, or Fully Outsourced: Finding the Right Model
12:15 pm
- Comparing the pros and cons of fully in-house, fully outsourced, and hybrid approaches to program management
- Leveraging vendor expertise for complex countries or niche therapies while maintaining control over core markets
- Learning from real-world case studies on outsourcing, internalizing, and transitioning programs smoothly
Wednesday 25th March 2026
Fireside Discussion: Driving Smarter Decisions by Clarifying the Role of RWD in EAPs
12:00 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
