Nora Pöntynen
Senior Principal Global Medical Advisor LEO Pharma A/S
Seminars
Tuesday 20th October 2026
Panel Discussion: Driving Smarter Decisions by Clarifying the Role of RWD in Early Access Programmes
3:30 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
Wednesday 21st October 2026
Transitioning Early & Managed Access Programmes from In House Teams to Vendors
1:45 pm
- Managing programme handovers without disrupting active patient supply
- Preparing affiliates and physicians for new systems, workflows, and points of contact
- Preserving responsiveness and accountability when execution becomes more layered
- Learning how peers maintained confidence and continuity during vendor transitions
